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Testing the Use of Combination Therapy in Adult Patients With Newly Diagnosed Multiple Myeloma, the EQUATE Trial (EQUATE)
Lantis, Kristin - kllantis@vcu.edu
Yazbeck, Victor, Y
NCT04566328
HM20022350
Inclusion Criteria:
* STEP 0 - Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2 (PS 3 allowed if secondary to pain)
* STEP 0 - Patient must have newly diagnosed multiple myeloma (MM) by International Myeloma Working Group (IMWG) criteria
* STEP 0 - Patient must agree to register to the mandatory REVLIMID Risk Evaluation and Mitigation Strategy (RevREMS) program and be willing and able to comply with the requirements of RevREMS
* STEP 0 - Patient must be able to undergo diagnostic bone marrow aspirate following preregistration.
* NOTE: Bone marrow aspirate specimen must be submitted to Adaptive Biotechnologies for clonoSEQ Assay
* NOTE: Adaptive Biotechnologies will release results to the diagnostic Portal from the Clonality (ID) test within fourteen (14) days of receipt and reconciliation of fresh bone marrow specimen to the submitting institution
* STEP 1 - Patient must meet all eligibility criteria in STEP 0 with exception of allergy requirement
* STEP 1 - Institution must have received the Clonality (ID) test results from Adaptive Biotechnologies and dominant sequences were identified
* STEP 1 - Patient must have standard risk MM as defined by the Revised International Staging System (RISS) stage I or II
* NOTE: R-ISS stage is based on serum beta2 microglobulin, albumin and lactate dehydrogenase (LDH) levels along with presence of chromosomal abnormalities (CA) detected by interphase fluorescent in situ hybridization (iFISH). Presence of del(17p), t(4;14), and/or t(14;16) is considered high risk and absence of these, including any other findings, are standard risk
* R-ISS stage
* Stage I: ISS stage I \[beta2 macroglobulin \< 3.5 mg/L, albumin \> 3.5 g/dL\] AND standard-risk CA AND normal LDH
* Stage II: Not R-ISS stage I or III
* Stage III: ISS stage III \[beta2 macroglobulin \> 5.5 mg/L\] AND high-risk CA OR high LDH (\> upper limit of normal) \[patients with stage III are ineligible\]
* STEP 1 - Patient must have measurable or evaluable disease as defined by having one or more of the following, obtained within 28 days prior to registration:
* \>= 1 g/dL monoclonal protein (M-protein) on serum protein electrophoresis
* \>= 200 mg/24 hours of monoclonal protein on a 24-hour urine protein electrophoresis
* Involved free light chain \>= 10 mg/dL or \>= 100 mg/L AND abnormal serum immunoglobulin kappa to lambda free light chain ratio (\< 0.26 or \> 1.65)
* Monoclonal bone marrow plasmacytosis \>= 30% (evaluable disease)
* STEP 1 - Patients must have a serum protein electrophoresis (SPEP), urine protein electrophoresis (UPEP), and serum free light chain (FLC) assay performed within 28 days prior to registration. In addition, a bone marrow biopsy and/or aspirate is required within 28 days if bone marrow is being followed for response
* NOTE: UPEP (on a 24-hour collection) is required, no substitute method is acceptable. Urine must be followed monthly if the baseline urine M-spike is \>= 200 mg/24 hr. Please note that if both serum and urine M-components are present, both must be followed in order to evaluate response
* NOTE: The serum free light chain test is required to be done if the patient does not have measurable disease in the serum or urine. Measurable disease in the serum is defined as having a serum M-spike \>= 1 g/dL. Measurable disease in the urine is defined as having a urine M-spike \>= 200 mg/24 hr
* STEP 1 - Calculated creatinine clearance \> 30 mL/min (obtained =\< 14 days prior to Step 1 registration)
* STEP 1 - Absolute neutrophil count (ANC) \>= 1000/mm\^3 (obtained =\< 14 days prior to Step 1 registration)
* STEP 1 - Untransfused platelet count \>= 75,000/mm\^3 (obtained =\< 14 days prior to Step 1 registration)
* STEP 1 - Hemoglobin \>= 8.0 g/dL (obtained =\< 14 days prior to Step 1 registration)
* STEP 1 - Total bilirubin =\< 1.5 x ULN (institutional upper limit of normal) (obtained =\< 14 days prior to Step 1 registration)
* STEP 1 - Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\< 3 x ULN (obtained =\< 14 days prior to Step 1 registration)
* STEP 1 - Patient must have received no more than one cycle (28 days or less) of prior chemotherapy and no more than 160 mg of prior dexamethasone (or equivalent dose of prednisone) for treatment of symptomatic myeloma. Patient must not have been exposed to daratumumab for treatment of symptomatic myeloma. Prior radiation therapy to symptomatic lesions is allowed provided there are no residual toxicity related to radiation and blood counts meet the study requirements. Radiation treatment must be completed at least 14 days prior to Step 1 registration
* STEP 1 - Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of randomization are eligible for this trial
* STEP 1 - For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
* STEP 1 - Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
* STEP 1 - Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
* STEP 1 - Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better. Patients must not have evidence of current uncontrolled cardiovascular conditions, including hypertension, cardiac arrhythmias, congestive heart failure, unstable angina, or myocardial infarction within 6 months prior to Step 1 registration
* STEP 1 - Patient may have a history of current or previous deep vein thrombosis (DVT) or pulmonary embolism (PE) but must be willing to take some form of anti-coagulation as prophylaxis if they are not currently on full-dose anticoagulation
* STEP 1 - Patients with a history of chronic obstructive pulmonary disease (COPD) must have FEV1 testing done within 28 days prior to Step 1 registration and the forced expiratory volume in 1 second (FEV1) must be \> 50% of predicted normal
* STEP 2 - Institution must have received Tracking (MRD) test results from Adaptive Biotechnologies
* STEP 2 - Patient must have completed the Step 1 Induction phase of this protocol without experiencing progression
* STEP 2 - Patient must be registered to Step 2 within 8 weeks of completing Step 1 Induction Treatment, counting from last day of completion of last cycle
* STEP 2 - Patient must have an ECOG performance status (PS) of 0-2 (PS 3 allowed if secondary to pain)
* STEP 2 - Any adverse event(s) related to Step 1 Induction Treatment must have resolved to grade 2 or less
* STEP 2 - Hemoglobin \>= 8 g/dL (obtained within 14 days prior to Step 2 randomization)
* STEP 2 - Platelet count \>= 50,000/mm\^3 (obtained within 14 days prior to Step 2 randomization)
* STEP 2 - Absolute neutrophil count (ANC) \>= 1000/mm\^3 (obtained within 14 days prior to Step 2 randomization)
* STEP 2 - Calculated creatinine clearance \>= 30 mL/min (obtained within 14 days prior to Step 2 randomization)
* STEP 2 - Total bilirubin =\< 1.5 x ULN (Institutional upper limit of normal) (obtained within 14 days prior to Step 2 randomization)
* STEP 2 - ALT and AST \< 3 x ULN (obtained within 14 days prior to Step 2 randomization)
Exclusion Criteria:
* STEP 0 - Patient must not have any known allergies, hypersensitivity, or intolerance to corticosteroids, monoclonal antibodies or human proteins, or their excipients (refer to respective package inserts or Investigator's Brochure), or known sensitivity to mammalian-derived products
* STEP 1 - Women must not be pregnant or breast-feeding due to the potential harm and teratogenic effects to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. All females of childbearing potential must have a blood test or urine study with a sensitivity of at least 25 mIU/mL within 10-14 days prior to Step 1 registration to rule out pregnancy and again within 24 hours prior to the first dose of lenalidomide. Females of childbearing potential must also agree to ongoing pregnancy testing while on protocol treatment. A female of childbearing potential is defined as any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria:
* Has achieved menarche at some point,
* Has not undergone a hysterectomy or bilateral oophorectomy; or
* Has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
* STEP 1 - Women of childbearing potential must not expect to conceive children by using accepted and effective method(s) of contraception (for this protocol defined as the use of TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME for 1) at least 28 days before starting protocol treatment; 2) while participating in the study; 3) during dose interruptions; and 4) for at least 3 months days after the last dose of protocol treatment) OR by practicing true abstinence from sexual intercourse for the duration of their participation in the study (periodic abstinence \[e.g., calendar, ovulation, symptothermal, post-ovulation methods\] and withdrawal are not acceptable methods of contraception). Men must not expect to father children by practicing true abstinence from sexual intercourse for the duration of their participation in the study (periodic abstinence \[e.g., calendar, ovulation, symptothermal, post-ovulation methods\] and withdrawal are not acceptable methods of contraception) OR use a latex condom during sexual contact with a female of child bearing potential while participating in the study and for at least 3 months after the last dose of protocol treatment even if they have had a successful vasectomy. Men must also agree to abstain from donating sperm while on study treatment and for 3 months after the last dose of protocol treatment even if they have had a successful vasectomy. Both women and men must both agree to abstain from donating blood during study participation and for at least 28 days after the last dose of protocol treatment
* STEP 1 - Patient must not have peripheral neuropathy \>= grade 2 on clinical examination or grade 1 with pain at time of Step 1 registration
* STEP 1 - Patient must not have any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol
* STEP 1 - Patient must not have moderate or severe persistent asthma within the past 2 years, or uncontrolled asthma of any classification
* NOTE: Patients who currently have controlled intermittent asthma or controlled mild persistent asthma are allowed to register
* STEP 1 - Patient must not receive any other concurrent chemotherapy, or any ancillary therapy considered investigational while on this protocol
* NOTE: Bisphosphonates are considered to be supportive care rather than therapy, and are thus allowed while on protocol treatment
* STEP 2 - Patient must not have received any non-protocol therapy outside of the assigned Step 1 Induction treatment including stem cell transplant
* STEP 2 - Women must not be pregnant or breast-feeding due to the potential harm and teratogenic effects to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. All females of childbearing potential must have a blood test or urine study with a sensitivity of at least 25 mIU/mL within 10-14 days prior to Step 2 randomization to rule out pregnancy and again within 24 hours prior to the first dose of lenalidomide. Females of childbearing potential must also agree to ongoing pregnancy testing while on protocol treatment. A female of childbearing potential is defined as any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria:
* Has achieved menarche at some point,
* Has not undergone a hysterectomy or bilateral oophorectomy; or
* Has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
* STEP 2 - Women of childbearing potential must not expect to conceive children by using accepted and effective method(s) of contraception (for this protocol defined as the use of TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME for 1) at least 28 days before starting protocol treatment; 2) while participating in the study; 3) during dose interruptions; and 4) for at least 3 months days after the last dose of protocol treatment) OR by practicing true abstinence from sexual intercourse for the duration of their participation in the study (periodic abstinence \[e.g., calendar, ovulation, symptothermal, post-ovulation methods\] and withdrawal are not acceptable methods of contraception).
Men must not expect to father children by practicing true abstinence from sexual intercourse for the duration of their participation in the study (periodic abstinence \[e.g., calendar, ovulation, symptothermal, post-ovulation methods\] and withdrawal are not acceptable methods of contraception) OR use a latex condom during sexual contact with a female of child bearing potential while participating in the study and for at least 3 months after the last dose of protocol treatment even if they have had a successful vasectomy. Men must also agree to abstain from donating sperm while on study treatment and for 3 months after the last dose of protocol treatment even if they have had a successful vasectomy. Both women and men must both agree to abstain from donating blood during study participation and for at least 28 days after the last dose of protocol treatment DRUG: Bortezomib, BIOLOGICAL: Daratumumab and Hyaluronidase-fihj, DRUG: Dexamethasone, DRUG: Lenalidomide, OTHER: Quality-of-Life Assessment
Plasma Cell Myeloma, RISS Stage I Plasma Cell Myeloma, RISS Stage II Plasma Cell Myeloma
Comparing Combinations of Drugs to Treat Newly Diagnosed Multiple Myeloma (NDMM) When a Stem Cell Transplant is Not a Medically Suitable Treatment
Sharon Palmer - spalmer@swog.org
NCT05561387
Inclusion Criteria:
* Participants must have documented multiple myeloma satisfying standard International Myeloma Working Group (IMWG) diagnostic criteria within 28 days prior to registration
* Participants must have measurable disease within 28 days prior to registration as defined by any of the following:
* Immunoglobulin (Ig) G myeloma (serum monoclonal paraprotein \[M-protein\] level \>= 0.5 gram/deciliter \[g/dL\] or urine M-protein level \>= 200 milligram\[mg\]/24 hours\[hrs\]); OR
* IgA, IgM, IgD, or IgE multiple myeloma (serum M-protein level \>= 0.2 g/dL or urine M-protein level \>= 200 mg/24 hrs); OR
* Light chain multiple myeloma (serum immunoglobulin free light chain \>= 10 mg/dL and abnormal serum immunoglobulin kappa lambda free light chain ratio)
* All disease must be assessed and documented on the baseline/pre-registration tumor assessment form
* Participants must have a calculated myeloma frailty index (Myeloma Frailty Score Calculator; http://www.myelomafrailtyscorecalculator.net/) categorized as frail or intermediate fit (regardless of age) within 28 days prior to registration
* For Participants Meeting "Frail" Status:
* Participants with any degree of kidney dysfunction are allowed; however, participants on dialysis are not eligible
* For Participants Meeting "Frail" Status:
* Hemoglobin \>= 7 g/dL (must be performed within 28 days prior to registration)
* Note: growth factor and transfusion utilization are allowed if cytopenias are considered secondary to bone marrow involvement from MM)
* For Participants Meeting "Frail" Status:
* Platelets \>= 50 x 10\^9/L (must be performed within 28 days prior to registration)
* Note: growth factor and transfusion utilization are allowed if cytopenias are considered secondary to bone marrow involvement from MM)
* For Participants Meeting "Frail" Status:
* Absolute neutrophil count (ANC) \>= 0.75 x10\^9/L (must be performed within 28 days prior to registration)
* Note: growth factor and transfusion utilization are allowed if cytopenias are considered secondary to bone marrow involvement from MM)
* For Participants Meeting "Intermediate Fit" Status, one or more of the following criteria must be present:
* Kidney dysfunction showing calculated creatinine clearance (CrCl) \<30 ml/min.
* Actual lab serum creatinine value with a minimum of 0.7 mg/dL.
* Participants must have bone marrow function assessed and meet the below criteria ranges:
* Hemoglobin between 7-8 g/dL, OR
* Platelets between 50-75 x10\^9/L, OR
* ANC between 0.75-1 x10\^9/L
* Note: growth factor and transfusion utilization are allowed as long as cytopenias are considered secondary to bone marrow involvement from MM)
* Revised International Staging System (R-ISS) stage III disease
* Note: All labs must be performed within 28 days prior to registration
* Participants must have a complete medical history and physical exam within 28 days prior to registration
* Participants must have whole body imaging within 60 days prior to registration. The recommended method of imaging is a positron emission tomography/computed tomography (PET/CT); a low-dose whole body CT scan or whole-body magnetic resonance imaging (MRI) or skeletal survey should be done only if a PET/CT scan cannot be done or is non-feasible. This must be documented in the comments section of the Onstudy form.
* Total bilirubin =\< 2 times institutional upper limit of normal (ULN) unless history of Gilbert's disease. Participants with history of Gilbert's disease must have total bilirubin =\< 5 x institutional ULN (within 28 days prior to registration)
* Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 3 × institutional ULN (within 28 days prior to registration)
* Participants must have adequate cardiac function, as assessed by the treating physician within 14 days prior to registration. Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification and must not be assessed as class 3 or 4
* Participants with known diabetes must show evidence of controlled disease within 14 days prior to registration. Uncontrolled diabetes is defined as: A glycosylated hemoglobin (Hg)A1C \> 7
* Participants with known human immunodeficiency virus (HIV)-infection must be receiving anti-retroviral therapy and have an undetectable viral load test on the most recent test result obtained, within 6 months prior to registration
* All participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load on suppressive therapy within 28 days prior to registration
* Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment, participant must have an undetectable HCV viral load within 28 days prior to registration
* Participants must have an Eastern Cooperative Oncology Group (ECOG)/Zubrod performance status score of 0-2 (Note: Participants with ECOG/Zubrod performance score \[PS\] 3, especially where the deterioration of PS is considered secondary to the MM diagnosis, will be allowed)
* Participants must be offered the opportunity to participate in specimen banking. With participant consent, specimens must be collected and submitted via the Southwest Oncology Group (SWOG) specimen tracking system
* Participants who are able to complete the patient-reported outcomes measures in English or Spanish must agree to participate in the PRO portion of the study
* Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines. For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations
Exclusion Criteria:
* Participants must not have received any prior systemic therapy for multiple myeloma with the exception of any one or more of the following:
* An emergency use of a short course of corticosteroids (equivalent of dexamethasone 160 mg) any time before registration, or
* Up to one complete cycle of a non-daratumumab and hyaluronidase-fihj containing anti-myeloma regimen (1 cycle = 21 or 28 days depending on the regimen being used), or
* Localized palliative radiation therapy for multiple myeloma, as long as the radiation therapy is completed at least 3 days prior to starting the systemic treatment as per the study protocol.
* Participants must not have evidence of grade 4 peripheral neuropathy prior to study registration
* Participants must not have uncontrolled blood pressure within 14 days prior to registration. Uncontrolled blood pressure: systolic blood pressure (SBP) \> 140 mmHg or diastolic blood pressure (DBP) \> 90 mmHg. Participants are permitted to be receiving multiple anti-hypertensive medications (unless otherwise indicated in the study). All blood pressure measurements within the 14 days prior to registration must be SBP =\< 140 and DBP =\< 90. A participant with a single blood pressure elevation who upon rechecking has a normal blood pressure will remain eligible at the discretion of the registering investigator.
* Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen.
* Participants must not be pregnant or nursing. Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 24 consecutive months or who has semen likely to contain sperm is considered to be of "reproductive potential." In addition to routine contraceptive methods, "effective contraception" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation/occlusion, and vasectomy with testing showing no sperm in the semen. DRUG: Bortezomib, DRUG: Daratumumab and Hyaluronidase-fihj, DRUG: Dexamethasone, DRUG: Lenalidomide, OTHER: Quality-of-Life Assessment, OTHER: Questionnaire Administration
Plasma Cell Myeloma
A Study to Evaluate Preventive Treatments for Talquetamab-related Oral Toxicity (Talisman)
Study Contact - Participate-In-This-Study1@its.jnj.com
NCT06500884
Inclusion Criteria:
* Multiple myeloma (MM) according to IMWG diagnostic criteria
* Were triple-class exposed (received prior treatment with a PI, an IMiD, and anti CD38 mAb)
* Documented evidence of progressive disease based on investigator's determination of response by IMWG criteria on or after their last regimen
* Have an Eastern Cooperative Oncology Group-performance status (ECOG-PS) of 0 or 1 at screening. Participants with ECOG-PS 2 or 3 are eligible for the study if the ECOG-PS score is related to stable physical limitations (e.g., wheelchair-bound due to prior spinal cord injury) and not related to multiple myeloma or associated therapy
* Be willing and able to adhere to the lifestyle restrictions specified in the protocol
Exclusion Criteria:
* Contraindications or life-threatening known allergies, hypersensitivity, or intolerance to any study drug or its excipients
* Stroke, transient ischemic attack, or seizure within 6 months prior to screening
* Any of the following within 6 months prior to the first dose of study treatment: severe or unstable angina, myocardial infarction; major thromboembolytic event (e.g., pulmonary embolism, cerebrovascular accident), clinically significant ventricular arrythmia or heart failure New York Heart Association functional classification Class III or IV. Uncomplicated deep vein thrombosis is not considered exclusionary
* Major surgery or had significant traumatic injury within 2 weeks prior to the start of administration of talquetamab, or will not have fully recovered from surgery, or has major surgery planned during the time the participant is expected to be treated in the study or within 2 weeks after administration of the last dose of study treatment
* A WETT score suggesting severe dysgeusia at screening. Also unresolved/severe dysgeusia referred by the participant or a finding in the physical examination/oral cavity inspection. Some examples include leukoplakia, prior mouth cancers, extensive dental caries, severe periodontitis, active oral infections, candidiasis, parotic gland removal, or radiotherapy with resultant xerostomia DRUG: Talquetamab, DRUG: Prophylaxis A, DRUG: Prophylaxis B, DRUG: Prophylaxis C
Relapse Multiple Myeloma, Refractory Multiple Myeloma
Testing Teclistamab (TECVAYLI) in Combination With Iberdomide for Relapsed or Refractory Multiple Myeloma
ctrrecruit@vcu.edu
NCT06465316
Inclusion Criteria:
* Patients must have histologically or cytologically confirmed multiple myeloma (MM), as defined in the International Myeloma Working Group (IMWG) criteria
* If patients have undergone autologous stem cell transplant (SCT), day 0 of SCT must be \> 100 days to be eligible for the study
* Patients must have had disease progression after ≥ 4 prior lines of anti-myeloma treatments including one proteasome inhibitor (e.g., bortezomib, carfilzomib, ixazomib), one immunomodulatory imide drug (ImiD) (e.g., thalidomide, lenalidomide, pomalidomide \[POM\]), and one anti-CD38 monoclonal antibody (e.g., daratumumab, isatuximab)
* Patients must have measurable disease, defined as:
* Serum M-protein ≥ 0.5 g/dL (≥ 5 g/L)
* Urine M-protein ≥ 200 mg/24 h
* Serum free light chain (FLC) assay: "involved" FLC level ≥ 10 mg/dL (≥ 100 mg/L) and an abnormal serum free light chain ratio (\< 0.26 or \> 1.65)
* Note: Patients with non-secretory disease will be allowed to participate
* Age ≥ 18 years
* Because no dosing or adverse event data are currently available on the use of iberdomide in combination with teclistamab in patients \< 18 years of age, children are excluded from this study
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60)
* Hemoglobin ≥ 7.0 g/dL (≤ 28 days prior to registration) (Without growth factor support, blood transfusion, or platelet stimulating agents for the past 7 days, excluding erythropoietin)
* Absolute neutrophil count ≥ 1,000/mcL (≤ 28 days prior to registration) (Without growth factor support, blood transfusion, or platelet stimulating agents for the past 7 days, excluding erythropoietin)
* Platelets ≥ 50,000/mcL (≤ 28 days prior to registration) (Without growth factor support, blood transfusion, or platelet stimulating agents for the past 7 days, excluding erythropoietin)
* Total bilirubin ≤ 2 x institutional upper limit of normal (ULN) (≤ 28 days prior to registration)
* Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT)(serum glutamic pyruvic transaminase \[SGPT\]) ≤ 3 x institutional ULN (≤ 28 days prior to registration)
* Estimated glomerular filtration rate (eGFR) \> 30 mL/min (≤ 28 days prior to registration)
* Spot urine (albumin/creatine ratio) ≤ 500mg/g (56 mg/mmol) OR urine dipstick negative/trace (if \> 1+ only eligible if confirmed ≤ 500 mg/g (56 mg/mmol) by albumin/creatinine ratio (spot urine from first void) (≤ 28 days prior to registration)
* Note: Laboratory results obtained during screening should be used to determine eligibility criteria. In situations where laboratory results are outside the permitted range, the investigator may re-test the subject and the subsequent within range screening result may be used to confirm eligibility
* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
* Patients with treated brain metastases are eligible if follow-up brain imaging done a minimum of 28 days after completion of central nervous system (CNS)-directed therapy shows no evidence of progression
* Patients with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate CNS specific treatment is not required and is unlikely to be required during the first cycle of therapy
* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class II or better
* Based on the mechanism of action, teclistamab may cause fetal harm when administered to a pregnant woman. Females of child-bearing potential (FCBP): should use effective contraception during treatment with teclistamab and for 5 months after the last dose. FCBP should not breast feed during treatment with teclistamab and for 5 months after the last dose. Should a FCBP become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. The effects of iberdomide on the developing human fetus are unknown. However, IMiDs are known to be teratogenic. FCBP must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 10-14 days prior to starting iberdomide, and again within 24 hours. FCBP must either commit to continued abstinence from heterosexual intercourse or begin two acceptable methods of birth control-one highly effective method and one additional effective method-at the same time, at least 28 days before starting iberdomide, while taking iberdomide, and for 28 days following discontinuation from the study. Examples of highly effective methods are intrauterine device, hormonal contraceptives, tubal ligation, or partner's vasectomy. Examples of barrier method are male condom, diaphragm, or cervical cap. FCBP must also agree to ongoing pregnancy testing. Men must practice complete abstinence or agree to use a condom during sexual contact with FCBP while participating in the study, during dose interruptions, and for at least 28 days following discontinuation from the study, even if he has undergone a successful vasectomy. All patients must be counseled at a minimum of every 28 days about pregnancy precautions and risk of fetal exposure
* Men must agree to abstain from donating and semen or sperm while taking iberdomide, during dose interruptions, and for at least 28 days after the last dose of iberdomide. FCBP must agree not to donate eggs (ova, oocytes) for the purpose of reproduction during this period
* All patients must agree to abstain from donating blood products while taking iberdomide and for at least 28 days after the last dose of iberdomide
* Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study subjects
* Willingness to adhere to the study visit schedule and other protocol requirements and provide mandatory blood and bone marrow specimens for correlative research
* Willingness to return to the enrolling institution for follow-up
Exclusion Criteria:
* Patients who have active plasma cell leukemia, active amyloid light chain (AL) (primary) amyloidosis, active polyneurophathy, organomegaly, endocrinopathy, monoclonal gammopathy and skin changes (POEMS) syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal plasma proliferative disorder, myeloma protein, and skin changes), and Waldenstrom macroglobulinemia are ineligible
* If a patient develops recurrent/refractory (R/R) disease while receiving the most recent line of therapy, there is no need for a washout period
* Patients who have had prior anti-BCMA directed bispecific antibody (BsAb) therapy exposure (prior treatment with anti-BCMA directed antibody drug conjugate, anti-BCMA-directed chimeric antigen receptor (CAR) T cell therapy, and prior non-BCMA-targeting BsAb are permitted)
* Patients who have had prior treatment with a cereblon E3 ligase modulator, including mezigdomide, iberdomide, and CFT7455 (all currently in clinical development)
* Patients who received plasmapheresis ≤ 7 days prior to registration
* Patients who received a prior allogeneic stem cell transplant. Autologous SCT is allowed
* Patients who received a live or live-attenuated vaccine ≤ 30 days prior to registration. Patients are allowed to receive a COVID-19 vaccine at any timepoint during protocol treatment
* Systemic active infection requiring treatment
* Any unresolved toxicity ≥ grade 2 from previous treatment except for alopecia or peripheral neuropathy up to grade 2
* Patients who have had any major surgery ≤ 4 weeks prior to registration
* Patients with uncontrolled intercurrent illness or any other significant condition(s) that would make this protocol unreasonably hazardous
* Patients with evidence of active mucosal or internal bleeding
* Current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis. Stable chronic liver disease (including Gilbert's syndrome or asymptomatic gallstones) or hepatobiliary involvement of malignancy is acceptable if participant otherwise meets entry criteria
* Patients with known immediate or delayed hypersensitivity reaction or idiosyncratic reaction to drugs chemically related to teclistamab or iberdomide, or any of the components of the study treatment
* Patients who are taking any anticancer therapy other than hormonal therapy (for prostrate or breast cancer) and palliative radiotherapy (defined as radiation to ≤ 3 sites of active multiple myeloma)
* Patients who require immunosuppressive medications including, but not limited to, systemic corticosteroids at doses exceeding 10 mg/day of prednisone or equivalent. Use of immunosuppressive medications for the management of iberdomide-related adverse events (AEs) or in subjects with contrast allergies is acceptable. In addition, use of inhaled, topical, intranasal corticosteroids or local steroid injection (e.g., intra-articular injection) is permitted. Temporary use of corticosteroids for concurrent illnesses (e.g., food allergies, computed tomography \[CT\] scan contrast hypersensitivity, pneumonia, etc.) are acceptable
* Patients who require medications that are strong inhibitors or inducers of CYP3A4/5
* Patients who are receiving any other investigational agents
* Patients with uncontrolled intercurrent illness or any other significant condition(s) that would make participation in this protocol unreasonably hazardous
* Pregnant women are excluded from this study because iberdomide is a thalidomide analog and thalidomide is a known human teratogen. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with iberdomide, breastfeeding should be discontinued if the mother is treated with iberdomide. These potential risks may also apply to other agents used in this study
* Patients who are unable or unwilling to undergo protocol required thromboembolism prophylaxis are excluded PROCEDURE: Biospecimen Collection, PROCEDURE: Bone Marrow Aspiration, PROCEDURE: Bone Marrow Biopsy, PROCEDURE: Computed Tomography, DRUG: Iberdomide, PROCEDURE: Magnetic Resonance Imaging, PROCEDURE: Positron Emission Tomography, DRUG: Teclistamab
Recurrent Multiple Myeloma, Refractory Multiple Myeloma
EAP for subjects receiving Idecabtagene Vicleucel That is Nonconforming for Commercial Release
Hall, Charles, E. - hallce3@vcu.edu
Simmons, Gary, L.
NCT04771078
HM20021892
Inclusion Criteria:
• Had a participant-specific batch of Idecabtagene vicleucel (ide-cel) manufactured intended for commercial treatment; however, the final manufactured product was nonconforming and did not meet commercial release criteria
• Remanufacturing is deemed not feasible or clinically inappropriate per assessment of the treating physician in discussion with the participant
• Clinically stable
Exclusion Criteria:
• Has a hypersensitivity to the active substance or to any of the excipients
• No experience of a significant worsening in clinical status that would, in the opinion of the treating physician, either increase the risk of Adverse Events associated with lymphodepleting chemotherapy, or exclude them from treatment with nonconforming Idecabtagene vicleucel (ide-cel)
• Has any condition and/or laboratory abnormality that places the participant at unacceptable risk if he/she were to participate in the Expanded Access Protocol based on the Investigator's judgement Other protocol-defined inclusion/exclusion criteria apply
Biological: Nonconforming idecabtagene vicleucel,
drug: Idecabtagene vicleucel, Modality: Immunotherapy
Multiple Myeloma
BB2121, Multiple Myeloma, Expanded Access, idecabtagene vicleucel, nonconforming, CAR T, EAP, Pre-Approval Access
Study Assessing Activity of Intravenous (IV) Etentamig Monotherapy Versus Standard Available Therapies in Adult Participants With Relapsed or Refractory Multiple Myeloma (CERVINO)
ABBVIE CALL CENTER - abbvieclinicaltrials@abbvie.com
NCT06158841
Inclusion Criteria:
* Eastern Cooperative Oncology Group (ECOG) performance of \<= 2.
* Diagnosis of relapsed/refractory (R/R) multiple myeloma (MM) during or after the participant's last treatment as stated in the protocol.
* Must have measurable disease with at least 1 of the following assessed within 28 days of enrollment:
* Serum M-protein \>= 0.5 g/dL (\>= 5 g/L).
* Urine M-protein \>= 200 mg/24 hours.
* In participants without measurable serum or urine M protein, serum free light chain (FLC) \>= 100 mg/L (10 mg/dL) (involved light chain)and an abnormal serum kappa lambda ratio.
* Must have received at least 2 or more lines of therapy, including a proteasome inhibitor (PI), an immunomodulatory imide (IMiD), and an anti-CD38 monoclonal antibody (mAb).
* Must be eligible to receive the Investigator's choice standard available therapy (SAT) based on approved prescribing information, previous MM treatment history, and institutional guidelines.
Exclusion Criteria:
* Clinically significant (per Investigator's judgment) drug or alcohol abuse within the last 6 months.
* Clinically significant conditions such as but not limited to the following: neurologic, psychiatric, endocrine, metabolic, immunologic, cardiovascular, pulmonary, or hepatic disease within the last 6 months that would adversely affect the participant's participation in the study.
* Central nervous system involvement of MM.
* Has received B-cell maturation antigen (BCMA)-targeted therapy. DRUG: Etentamig, DRUG: Carfilzomib, DRUG: Pomalidomide, DRUG: Elotuzumab, DRUG: Selinexor, DRUG: Bortezomib, DRUG: Dexamethasone
Multiple Myeloma
Cervino, Multiple Myeloma, Etentamig, Carfilzomib, Pomalidomide, Elotuzumab, Selinexor, Bortezomib, Dexamethasone
A Study of JNJ-68284528, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against B-cell Maturation Antigen (BCMA) in Participants With Multiple Myeloma (CARTITUDE-2)
Study Contact - Participate-In-This-Study1@its.jnj.com
NCT04133636
Inclusion Criteria:
* Cohort A: Received a minimum of 1 to a maximum of 3 prior lines of therapy including a proteasome inhibitor (PI) and immunomodulatory therapy (IMiD), and lenalidomide refractory per International Myeloma Working Group (IMWG) guidelines
* Cohort B: Received one line of prior therapy including a PI and an IMiD, and disease progression per IMWG criteria less than or equal to (\<=) 12 months after treatment with autologous stem cell transplantation (ASCT) or \<=12 months from the start of anti-myeloma therapy for participants who have not had an ASCT
* Cohort C: Previously treated with a PI, an IMiD, an anti-CD38 monoclonal antibody and B-cell maturation antigen (BCMA)-directed therapy
* Cohort D: Newly diagnosed multiple myeloma per IMWG with a history of 4 to 8 total cycles of initial therapy, including induction, high-dose therapy, and ASCT with or without consolidation
* Cohort E: Have newly diagnosed multiple myeloma without prior therapy (one cycle of prior therapy before enrollment is acceptable) and classified as high risk defined as either: 1) International Staging System (ISS) stage III criteria, Beta 2 microglobulin greater than or equal to (\>=) 5.5 milligrams per liter (mg/L) (via local or central laboratory assessment) or 2) high risk cytogenetic features del(17/17p), t (14;16), t(14;20), 1q amplification (at least 4 total copies) in at least 20 percent (%) of the total plasma cell population
* Cohort F:
* Participant must have a documented efficacy response of very good partial response (VGPR) or better, without progressive disease prior to enrollment, as assessed per IMWG 2016 criteria
* Received initial therapy as specified below. The dose/schedule of cycles administered will be as per standard of care. It is acceptable for up to 1 cycle of the protocol-specified regimens to be missing one of the listed agents (example, held due to toxicity). Acceptable combinations include: At least 5 to 8 cycles of initial therapy with daratumumab, bortezomib, lenalidomide and dexamethasone (D-VRd). The dose/schedule of cycles administered will be as per standard of care or; at least 4 to 8 cycles of initial therapy with daratumumab, lenalidomide and dexamethasone (D-Rd) or; at least 4 to 8 cycles of initial therapy with a carfilzomib-based triplet or quadruplet regimen
* Cohort G: Not considered for high-dose chemotherapy with autologous stem cell transplantation (ASCT) due to: a) Ineligibility due to advanced age; or b) Ineligibility due to presence of comorbid condition(s) likely to have a negative impact on tolerability of high-dose chemotherapy with ASCT; or c) Subject refusal of high-dose chemotherapy with ASCT as initial treatment
* Cohort H: Considered a candidate for high-dose chemotherapy with ASCT as initial treatment
* Cohorts A, B, C, E, G, H:
* Serum monoclonal paraprotein (M-protein) level greater than or equal to (\>=) 1.0 gram per deciliter (g/dL) or urine M-protein level \>=200 milligrams (mg)/24 hours
* Light chain multiple myeloma in whom only measurable disease is by serum free light chain (FLC) levels in the serum: Serum immunoglobulin FLC \>=10 mg/dL and abnormal serum immunoglobulin kappa lambda FLC ratio
* Cohort A: For participants with neither serum nor urine measurable disease, baseline positron emission tomography/ computed tomography (PET/CT) or whole -body magnetic resonance imaging (MRI) may be used to satisfy the measurable disease criteria. A minimum of one lesion with a bi-dimensional measurement of at least 1 centimeter (cm)\*1 cm is required
* Cohorts B, C: For participants with neither serum nor urine measurable disease, baseline positron emission tomography/ computed tomography (PET/CT) or whole body magnetic resonance imaging (MRI) may be used to satisfy the measurable disease criteria
* Cohorts A, B, C, D, E, F, G, H: Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1
Exclusion Criteria:
* Cohorts A, B, D, F: Any therapy that is targeted to BCMA
* Cohorts A, B, C, D, F: Prior treatment with chimeric antigen receptor T (CAR-T) therapy directed at any target
* Cohorts A, B, C, D, F:
* Ongoing toxicity from previous anticancer therapy must resolve to baseline levels or to Grade 1 or less except for alopecia or peripheral neuropathy
* Received a cumulative dose of corticosteroids equivalent to \>=70 mg of prednisone within the 7 days (Cohort A, B, C, F) or 14 days (Cohort D) prior to apheresis
* Serious underlying medical condition, such as (a) evidence of active viral or bacterial infection requiring systemic antimicrobial therapy, or uncontrolled systemic fungal infection; (b) active autoimmune disease or a history of autoimmune disease within 3 years; (c) overt clinical evidence of dementia or altered mental status; (d) any history of Parkinson's disease or other neurodegenerative disorder
* Cohorts A, B, C, D, E, F: Known active, or prior history of central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma
* Cohorts F, G, and H: Active malignancies (that is, progressing or requiring treatment change in the last 24 months) other than the disease being treated under study. The only allowed exceptions are: a) non-muscle invasive bladder cancer treated within the last 24 months that is considered completely cured; b) skin cancer (non-melanoma or melanoma) treated within the last 24 months that is considered completely cured; c) non-invasive cervical cancer treated within the last 24 months that is considered completely cured; d) localized prostate cancer (N0M0): with a Gleason score of greater than or equal to (=\>)6, treated within the last 24 months or untreated and under surveillance, with a Gleason score of 3+4 that has been treated more than 6 months prior to full study screening and considered to have a very low risk of recurrence, or history of localized prostate cancer and receiving androgen deprivation therapy and considered to have a very low risk of recurrence, e) breast cancer: adequately treated lobular carcinoma in situ or ductal carcinoma in situ, or history of localized breast cancer and receiving antihormonal agents and considered to have a very low risk of recurrence; f) malignancy that is considered cured with minimal risk of recurrence
* Cohorts E, G, and H: Frailty index of \>= 2 according to Myeloma Geriatric Assessment score DRUG: JNJ-68284528, DRUG: Lenalidomide, DRUG: Daratumumab, DRUG: Bortezomib, DRUG: Dexamethasone
Multiple Myeloma
Cellular Therapy, CAR-T Therapy, BCMA CAR-T
Comparing the Combination of Selinexor-Daratumumab-Velcade-Dexamethasone (Dara-SVD) With the Usual Treatment (Dara-RVD) for High-Risk Newly Diagnosed Multiple Myeloma
ctrrecruit@vcu.edu
NCT06169215
Inclusion Criteria:
* Presence of newly diagnosed (dx) multiple myeloma (MM) as defined by standard International Myeloma working group (IMWG).
* Presence of high risk cytogenetics using fluorescent in situ hybridization (FISH) \[del(17p), t(4;14), t(14;16), t(14;20), chromosome 1 abnormalities, MYC translocation, tetrasomies, complex karyotype, high lactate dehydrogenase (LDH), or extramedullary MM.
* Patients are allowed to have received one cycle of bortezomib-based doublet or triplet therapy. For instance, if a newly diagnosed patient with MM is in need of urgent therapy, they may be enrolled after having received one cycle of bortezomib, cyclophosphamide, dexamethasone.
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%).
* Absolute neutrophil count ≥ 1,000/mcL (\> 500 if bone marrow \[BM\] clonal plasma cell involvement greater than 50%).
* Platelets ≥ 100,000/mcL (\> 50,000 if BM clonal plasma cell involvement greater than 50%).
* Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (with the exception of patients with Gilbert's syndrome who have a high baseline bilirubin).
* Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT)(serum glutamate pyruvate transaminase \[SGPT\]) ≤ 3 × institutional ULN.
* Glomerular filtration rate (GFR) ≥ 30 mL/min.
* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
* Patients with treated brain involvement are eligible if follow-up brain imaging performed within 10 days after central nervous system (CNS)-directed therapy shows no.
* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better.
* The effects of selinexor (KPT-330) on the developing human fetus are unknown. For this reason and because selective nuclear export inhibitors as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men with partners of women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men (with partners of women of childbearing potential) treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of study treatment administration. Adequate contraception should continue for 7 months for females and for 4 months for males after completion of the study treatment.
* Female of childbearing potential (FCBP) must have a negative pregnancy test during screening. They must either commit to continue abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 4 weeks before therapy, while taking lenalidomide, during dose interruptions, and for 7 months after study treatment. If menstrual cycles are irregular, the pregnancy testing should occur every 2 weeks. Pregnancy testing and counseling should be performed if a patient misses her period or if there is any abnormality in her menstrual bleeding. Lenalidomide treatment must be discontinued during this evaluation.
* Men who are sexually active with FCBP must agree to use a latex or synthetic condom while taking lenalidomide, during dose interruptions and for up to 4 weeks after discontinuing lenalidomide, even if they have undergone a successful vasectomy. Male patients taking lenalidomide must abstain from donating blood, semen, or sperm during study participation and for at least 4 weeks after discontinuation from lenalidomide.
* Patients who are randomized to receive lenalidomide need to register into the mandatory Risk Evaluation and Mitigation Strategies (REMS) program and be willing and able to comply with the requirements of REMS.
* Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.
Exclusion Criteria:
* Patients who are in urgent need for MM therapy (such as in the setting of acute kidney injury, or high disease burden concerning for impending organ failure) may begin study treatment immediately after receiving one cycle of bortezomib combination (e.g. bortezomib-dexamethasone or cyclophosphamide-bortezomib-dexamethasone) or one course of pulse dose dexamethasone 20-40mg once daily for four days. No washout period is required.
* Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> grade 1) with the exception of alopecia.
* Patients who are receiving any other investigational agents.
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to selinexor (KPT-330) or other agents used in study.
* Concomitant medications: Supportive care therapies such as bone directed therapies (zoledronic acid, denosumab), intravenous immunoglobulin therapy (IVIG) and anti-viral agents are allowed and recommended as per standard of care (SOC). Strong CYP3A4 inhibitors and strong CYP3A4 inducers are prohibited, due to their respective increase or decrease in bortezomib exposure. If strong CYP3A4 inhibitors cannot be avoided, then patients will be monitored for signs of bortezomib toxicity and a dose reduction of bortezomib will be considered.
* Patients with uncontrolled intercurrent illness or any other significant condition(s) that would make participation in this protocol unreasonably hazardous.
* Pregnant women are excluded because this study involves an investigational drug that may cause genotoxic, teratogenic, and mutagenic effects on the developing fetus and newborn and drugs that have known genotoxic, teratogenic, or abortifacient effect.
* Because there is potential risk for adverse events in nursing infants secondary to treatment of the mother with the drugs used in this study, breastfeeding is not allowed during treatment for all drugs and for 2 months after last dose of bortezomib and 1 week after the last dose of selinexor. PROCEDURE: Biospecimen Collection, PROCEDURE: Bone Marrow Aspiration, PROCEDURE: Bone Marrow Biopsy, DRUG: Bortezomib, PROCEDURE: Computed Tomography, DRUG: Daratumumab and Recombinant Human Hyaluronidase, DRUG: Dexamethasone, DRUG: Lenalidomide, PROCEDURE: Magnetic Resonance Imaging, PROCEDURE: Positron Emission Tomography, DRUG: Selinexor
Multiple Myeloma
Screening for AL Amyloidosis in Smoldering Multiple Myeloma
Raymond Comenzo, MD - raymond.comenzo@tuftsmedicine.org
NCT06365060
Inclusion Criteria:
* Patients 40 years of age and older
* diagnosed with either Smoldering Multiple Myeloma or a Monoclonal Gammopathy
* dFLC greater than 23 mg/L
* abnormal FLC ratio
* If the patient has an eGFR less than 50 mL/min/1.73m2, the FLC ratio is inconsequential. The patient only needs to meet the age and dFLC criterion.
Exclusion Criteria:
* Patients younger than 40 years of age are not eligible
* Patients with a previous finding of amyloid in other biopsies will not be included
* Adults unable to consent are not eligible, including the cognitively impaired Pregnant women, pregnant minors, minors (i.e., individuals who are not yet adults), wards of the state, non-viable neonates, neonates of uncertain viability, and prisoners are not eligible Smoldering Multiple Myeloma
SMM, AL Amyloidosis
A Study of Comparing Talquetamab to Belantamab Mafodotin in Participants With Relapsed/Refractory Multiple Myeloma (MonumenTAL-5)
Study Contact - Participate-In-This-Study@its.jnj.com
NCT05461209
Inclusion Criteria:
• Documented multiple myeloma as defined by the criteria: a) multiple myeloma according to international myeloma working group (IMWG) diagnostic criteria b) measurable disease at screening, as assessed by central laboratory, defined by any of the following i) serum M-protein level greater than or equal to (>=) 1.0 gram per deciliter (g/dL) ii) urine M-protein level >=200 milligram (mg)/24 hours iii) Light chain multiple myeloma without measurable M-protein in the serum or the urine: serum free light chain (sFLC) >=10 milligram per deciliter (mg/dL) (central laboratory) and abnormal serum immunoglobulin kappa lambda free light chain (FLC) ratio
• Received at least 4 prior antimyeloma therapies including an anti-cluster of differentiation 38 (CD38) monoclonal antibody (mAb) (alone or in combination) and is refractory per IMWG criteria to at least one proteasome inhibitor (PI), and one immunomodulatory drug (IMiD)
• Documented evidence of progressive disease based on investigator's determination of response by IMWG criteria on or after their last regimen
• Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 at screening
• A female participant of childbearing potential must have a negative serum pregnancy test at screening, and must agree to further serum or urine pregnancy tests during the study and within 6 months after receiving the last dose of study treatment
Exclusion Criteria:
• Contraindications or life-threatening known allergies, hypersensitivity, or intolerance to any study drug or its excipients
• Stroke or seizure within 6 months prior to signing informed consent form (ICF)
• Prior or concurrent exposure to belantamab mafodotin
• Current corneal epithelial disease except mild punctate keratopathy
• Known active central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma. If either is suspected, negative whole brain magnetic resonance imaging (MRI) and lumbar cytology are required
Drug: Talquetamab, Drug: Belantamab Mafodotin
Relapsed/ Refractory Multiple Myeloma
CRISPR-Edited Allogeneic Anti-BCMA CAR-T Cell Therapy in Patients With Relapsed/Refractory Multiple Myeloma (CaMMouflage)
Caribou Biosciences - clinicaltrials@cariboubio.com
NCT05722418
Inclusion Criteria:
• Documented diagnosis of relapsed/refractory multiple myeloma (MM) with measurable disease (according to IMWG diagnostic criteria.)
• Received at least 3 prior MM treatment lines of therapy which must include a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-CD38 monoclonal antibody as part of a prior line of therapy, either in monotherapy or in combination.
• Eastern Cooperative Oncology Group performance status grade of 0 or 1.
• Adequate hematologic, renal, hepatic, pulmonary, and cardiac function.
Exclusion Criteria:
• Prior treatment with CAR-T cell therapy directed at any target.
• Autologous stem cell transplant within the last 6 weeks before lymphodepletion.
• Allogeneic stem cell transplant within 6 months before lymphodepletion.
• Known active or prior history of CNS involvement.
• Stroke or seizure within 6 months of signing ICF.
• Seropositive for or history of human immunodeficiency virus.
• Vaccinated with live, attenuated vaccine within 4 weeks prior to lymphodepletion.
• Hepatitis B infection.
• Hepatitis C infection.
• Known life-threatening allergies, hypersensitivity, or intolerance to CB-011 or its excipients.
BIOLOGICAL: CB-011
Relapsed/Refractory Multiple Myeloma
CaMMouflage, Allogeneic, Multiple Myeloma, Relapse Refractory Multiple Myeloma, CAR-T Cells, BCMA, Cell Therapy, Cellular Immuno-therapy, CB11A, CB-011, CB-011A, CAR-T, Anti BCMA, ALLO CAR T
Caring and Coping with Cancer (C3) (C3)
Winter, Marcia - mawinter@vcu.edu
Winter, Marcia
14620
HM20014307
Lymphoid Leukemia, Multiple Myeloma, Myeloid and Monocytic Leukemia, Non-Hodgkin's Lymphoma
A Multicenter Access and Distribution Protocol for Unlicensed Cryopreserved Cord Blood Units (CBUs)
Lisa Erickson, MPH - 10-CBA@ndmp.org
McCarty, John, M.
NCT01351545
HM13913
Inclusion Criteria:
* Disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment
* Signed informed consent (and signed assent, if applicable) obtained prior to study enrollment
* Pediatric and adult patients of any age
Exclusion Criteria:
* Patients who are receiving only licensed CBUs
* Cord blood transplant recipients at international transplant centers
* Patients who are enrolled on another IND protocol to access the unlicensed CBU(s)
* Patients whose selected unlicensed CBU(s) will be more than minimally manipulated DRUG: A multicenter access and distribution protocol for unlicensed cryopreserved cord blood units (CBUs)
Hematologic Malignancies, Inherited Disorders of Metabolism, Inherited Abnormalities of Platelets, Histiocytic Disorders, Acute Myelogenous Leukemia (AML or ANLL), Acute Lymphoblastic Leukemia (ALL), Other Acute Leukemia, Chronic Myelogenous Leukemia (CML), Myelodysplastic (MDS) / Myeloproliferative (MPN) Diseases, Other Leukemia, Hodgkin Lymphoma, Non-Hodgkin Lymphoma, Multiple Myeloma/ Plasma Cell Disorder (PCD), Inherited Abnormalities of Erythrocyte Differentiation or Function, Disorders of the Immune System, Autoimmune Diseases, Severe Aplastic Anemia
Distress in the Pediatric Oncology Setting: Intervention versus Natural Adaptation
Jewell, Andrea - Andrea.Jewell@vcuhealth.org
Rohan, Jennifer
NCT04409301
HM20019000
Myeloid and Monocytic Leukemia, Mycosis Fungoides, Multiple Myeloma, Melanoma, skin, Lymphoid Leukemia, Lung, Liver, Lip, Oral Cavity and Pharynx, Leukemia, other, Leukemia, Not Otherwise Specified, Larynx, Kidney, Kaposi's sarcoma, Ill-Defined Sites, Hodgkin's Lymphoma, Eye and Orbit, Esophagus, Corpus Uteri, Colon, Cervix, Breast, Brain and Nervous System, Bones and Joints, Anus, Any Site, Non-Hodgkin's Lymphoma, Other Digestive Organ, Other Female Genital, Other Endocrine System, Urinary Bladder, Thyroid, Stomach, Soft Tissue, Small Intestine, Rectum, Prostate, Pancreas, Ovary, Other Urinary, Other Skin, Other Respiratory and Intrathoracic Organs, Other Male Genital, Other Hematopoietic
Longitudinal Cohort Registry of Cancer Survivors
Hong, Susan - susan.hong@vcuhealth.org
Hong, Susan
17880
HM20021510
Anus, Any Site, Bones and Joints, Breast, Brain and Nervous System, Other Hematopoietic, Other Female Genital, Other Endocrine System, Other Digestive Organ, Non-Hodgkin's Lymphoma, Myeloid and Monocytic Leukemia, Mycosis Fungoides, Multiple Myeloma, Melanoma, skin, Lymphoid Leukemia, Lung, Liver, Lip, Oral Cavity and Pharynx, Leukemia, other, Leukemia, Not Otherwise Specified, Larynx, Kidney, Kaposi's sarcoma, Ill-Defined Sites, Hodgkin's Lymphoma, Eye and Orbit, Esophagus, Corpus Uteri, Colon, Cervix, Other Male Genital, Other Respiratory and Intrathoracic Organs, Other Urinary, Urinary Bladder, Thyroid, Stomach, Soft Tissue, Small Intestine, Rectum, Prostate, Pancreas, Ovary, Other Skin
National Cancer Institute "Cancer Moonshot Biobank" (moonshot)
Castellanos, Natasha, Guzy - castellanosn@vcu.edu
Poklepovic, Andrew, S
NCT04314401
HM20020956
Inclusion Criteria:
* Is consistent with OR has been diagnosed with one of the following:
* Colorectal cancer: stage IV
* Non-small cell or small cell lung cancer: stage III/IV
* Prostate cancer: metastatic prostate cancer
* Gastric cancer, not otherwise specified (NOS): stage IV
* Esophageal cancer, NOS: stage IV
* Adenocarcinoma of gastroesophageal junction: stage IV
* High grade serous ovarian cancer: stage III/IV
* Invasive breast carcinoma: stage III/IV
* Melanoma: stage III/IV
* Acute myeloid leukemia
* Multiple myeloma
* For the purposes of this study,
* Re-staging is allowed
* Having more than one primary cancer is allowed, if the patient is being treated solely for one of the eligible cancers listed above
* Patient should fit in one of the following four clinical scenarios (a-d)
* Undergoing diagnostic workup for one of the diseases listed for which treatment will likely include a new regimen of standard of care therapy OR
* Scheduled to begin treatment with a new regimen of standard of care therapy OR
* Currently progressing on a regimen of standard of care therapy OR
* Currently being treated with a regimen standard of care therapy, without evidence of progression
* Requirements for fresh tissue biospecimen collections at enrollment:
* For clinical scenarios a, b, and c above, freshly collected tumor tissue or bone marrow (BM) aspirate must be submitted at enrollment
* For clinical scenarios a and b, the fresh tissue collection must be prior to starting therapy
* For clinical scenario a, the biospecimen collection must be part of a standard of care medical procedure
* For clinical scenarios b or c, the biospecimen collection may be part of a standard of care medical procedure OR
* The biospecimen collection may be part of a study-specific procedure ("research only biopsy"), when the patient has a tumor amenable to image guided or direct vision biopsy and is willing and able to undergo a tumor biopsy for molecular profiling
* Note: For research-only biopsies, the biopsy must not be associated with a significant risk of severe or major complications or death; the procedure cannot be a mediastinal, laparoscopic, open or endoscopic biopsy; nor can the procedure be a brain biopsy; nor can the patient be under the age of majority as determined by each U.S. state
* Requirements for archival tissue:
* For clinical scenarios a and b above, archival tissue as outlined below must be submitted IF AVAILABLE
* For clinical scenarios c and d above, archival tissue as outlined below is REQUIRED
* Pre-existing archival material (formalin-fixed, paraffin-embedded \[FFPE\] block, BM aspirate, or unstained slides) that:
* Contains the cancer type for which the participant is enrolled, and
* Was collected no more than 5 years prior to initiation of therapy, and
* Contains at least a surface area of 5 mm\^2 and optimal surface area of 25 mm\^2 or 3-5 mL cryopreserved bone marrow aspirate to yield 200 million bone marrow mononuclear cells, and
* Contains at least 10% tumor content. 70% tumor content is optimal, and
* No more than 1 line of standard of care systemic therapy was administered from the date of archival material collection to the date of initiation of therapy
* Requirements for blood collection: ALL scenarios require fresh blood collection at enrollment
* Blood collection for clinical scenarios a, b, and c must take place within 1 week of fresh tumor specimen collection
* Blood collection for clinical scenario d must take place within 4 weeks of enrollment, and while patient is on treatment
* Age 13 or older
* Any sex
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2
* Ability to understand and willingness to sign an informed consent document. Consent may be provided by a Legally Authorized Representative (LAR) in accordance with 45 CFR 46.102(i)
* NCI PDMR INCLUSION CRITERIA: Patients with CRC with mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) status
* NCI PDMR INCLUSION CRITERIA: Patients with CRC who are 40 years old or younger at time of collection irrespective of mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) status
* NCI PDMR INCLUSION CRITERIA: Patients with BRCA that are either
* Any race/ethnicity with hormone receptor positive (ER+PR+, ER+PR-, or ER-PR+)
* African American with triple negative (ER-PR-HER2-)
* NCI PDMR INCLUSION CRITERIA: Patients with lung cancer (LCA), prostate cancer (PCA), gastroesophageal cancer (GEC), ovarian cancer (OV), acute myeloid leukemia (AML), multiple myeloma (MML)
Exclusion Criteria:
* Treated with or has already begun treatment with a non-standard of care therapeutic agent (investigational) in an interventional clinical trial
* For the purposes of this study, past enrollment in clinical trials whereby the patient was randomized and treated with standard-of-care anti-cancer treatment (chemotherapy regimen, surgery and radiation therapy) is allowed
* Uncontrolled intercurrent illness that in the physician's assessment would pose undue risk for biopsy
* Use of full dose coumarin-derivative anticoagulants such as warfarin are prohibited. Patients may be switched to low molecular weight (LMW) heparin at physician discretion
* Low molecular weight (LMW) heparin is permitted for prophylactic or therapeutic use
* Factor X inhibitors are permitted
* Use of anti-platelet drugs are permitted
* Stopping the anticoagulation treatment for biopsy, bone marrow aspirate, or resection should be per site standard operating procedure (SOP)
* NCI PDMR EXCLUSION CRITERIA: Patients with complete response
* NCI PDMR EXCLUSION CRITERIA: Patients with invasive fungal infections
* NCI PDMR EXCLUSION CRITERIA: Patients with active and/or uncontrolled infections or who are still recovering from an infection
* Actively febrile patients with uncertain etiology of febrile episode
* All antibiotics for non-prophylactic treatment of infection should be completed at least 1 week (7 days) prior to collection
* No recurrence of fever or other symptoms related to infection for at least 1 week (7 days) following completion of antibiotics
* NCI PDMR EXCLUSION CRITERIA: Patients with human immunodeficiency virus (HIV), active or chronic hepatitis (i.e. quantifiable hepatitis B virus \[HBV\]-deoxyribonucleic acid \[DNA\] and/or positive hepatitis B surface antigen \[HbsAg\], quantifiable hepatitis C virus \[HCV\]-ribonucleic acid \[RNA\]) or known history of HBV/HCV without documented resolution PROCEDURE: Biospecimen Collection, PROCEDURE: Computed Tomography, PROCEDURE: Magnetic Resonance Imaging, OTHER: Medical Chart Review, PROCEDURE: Paracentesis, PROCEDURE: Positron Emission Tomography
Acute Myeloid Leukemia, Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Clinical Stage IV Esophageal Adenocarcinoma AJCC v8, Clinical Stage IV Gastric Cancer AJCC v8, Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8, Esophageal Carcinoma, Fallopian Tube Carcinoma, Gastric Carcinoma, Hormone Receptor-Positive Breast Carcinoma, Invasive Breast Carcinoma, Lung Non-Small Cell Carcinoma, Lung Small Cell Carcinoma, Malignant Solid Neoplasm, Melanoma, Metastatic Prostate Carcinoma, Multiple Myeloma, Ovarian Carcinoma, Ovarian High Grade Serous Adenocarcinoma, Primary Peritoneal Carcinoma, Stage III Fallopian Tube Cancer AJCC v8, Stage III Lung Cancer AJCC v8, Stage III Ovarian Cancer AJCC v8, Stage IV Colorectal Cancer AJCC v8, Stage IV Fallopian Tube Cancer AJCC v8, Stage IV Lung Cancer AJCC v8, Stage IV Ovarian Cancer AJCC v8, Stage IVB Prostate Cancer AJCC v8, Triple-negative Breast Carcinoma