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8 Study Matches
EAP for subjects receiving Idecabtagene Vicleucel That is Nonconforming for Commercial Release
Hall, Charles, E. - hallce3@vcu.edu
Simmons, Gary, L.
NCT04771078
HM20021892
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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
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See this study on ClinicalTrials.gov
Show 76 locations
Study Locations
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| Location | Contacts |
|---|---|
| Allegheny Health Network Pittsburgh, Pennsylvania | |
| Avera McKennan Hospital & University Health Center Sioux Falls, South Dakota | |
| Beth Israel Deaconess Medical Center Boston, Massachusetts | |
| Boston Medical Center Boston, Massachusetts | |
| Cancer Center Of Kansas Wichita, Kansas | |
| Cancer Treatment Centers of America, Chicago Zion, Illinois | |
| Cedars-Sinai Medical Center Los Angeles, California | |
| City of Hope cancer Center Newnan, Georgia | |
| Cleveland Clinic Cleveland, Ohio | |
| Colorado Blood Cancer Institute Denver, Colorado | |
| Columbia-Presbyterian Medical Center New York, New York | |
| Dana Farber Cancer Institute Boston, Massachusetts | |
| Fox Chase Cancer Center Philadelphia, Pennsylvania | |
| Fred Hutchinson Cancer Research Center Seattle, Washington | |
| Froedtert Hospital BMT Medical College of Wisconsin Milwaukee, Wisconsin | |
| Greenville Health System Greenville, South Carolina | |
| H Lee Moffitt Cancer Center Tampa, Florida | |
| Hackensack University Medical Center Hackensack, New Jersey | |
| Henry Ford Hospital Detroit, Michigan | |
| Indiana University Cancer Center Indianapolis, Indiana | |
| Intermountain Healthcare - LDS Hospital Salt Lake City, Utah | |
| Karmanos Cancer Institute Detroit, Michigan | |
| Massachusetts General Hospital / Dana-Farber Cancer Institute Boston, Massachusetts | |
| Mayo Clinic Rochester, Minnesota | |
| Mayo Clinic - Jacksonville Jacksonville, Florida | |
| MedStar Georgetown University Hospital Washington D.C., District of Columbia | |
| Medical City Dallas Hospital Dallas, Texas | |
| Medical University of South Carolina Hollings Cancer Center Charleston, South Carolina | |
| Memorial Sloan Kettering Cancer Center New York, New York | |
| Methodist Hospital - Texas Transplant Institute San Antonio, Texas | |
| Mount Sinai Hospital New York, New York | |
| New York Presbyterian Cornell University New York, New York | |
| Northside Hospital, Inc Atlanta, Georgia | |
| Ohio State University Wexner Medical Center Columbus, Ohio | |
| Oregon Health and Science University OHSU Portland, Oregon | |
| Providence Portland Medical Center Portland, Oregon | |
| Robert H. Lurie Comprehensive Cancer Center Chicago, Illinois | |
| Roswell Park Cancer Institute Buffalo, New York | |
| Rush University Medical Center Chicago, Illinois | |
| Rutgers Cancer Institute of New Jersey New Brunswick, New Jersey | |
| Sarah Cannon Research Institute Nashville, Tennessee | |
| Spectrum Health Grand Rapids, Michigan | |
| St. David's South Austin Medical Center Austin, Texas | |
| Stanford University Palo Alto, California | |
| Texas Medical Center Houston, Texas | |
| Texas Oncology - Baylor Charles A. Sammons Cancer Center Dallas, Texas | |
| The University of Texas - MD Anderson Cancer Center Houston, Texas | |
| Thomas Jefferson University Philadelphia, Pennsylvania | |
| UCLA School of Medicine Los Angeles, California | |
| UT Southwestern Medical Center Simmons Comprehensive Cancer Center Dallas, Texas | |
| Univ of AR for Medical Sciences Little Rock, Arkansas | |
| University Hospitals Cleveland Medical Center Cleveland, Ohio | |
| University of Alabama Birmingham, Alabama | |
| University of California San Diego Moores Cancer Center La Jolla, California | |
| University of California San Francisco Medical Center San Francisco, California | |
| University of Chicago Chicago, Illinois | |
| University of Cincinnati Cincinnati, Ohio | |
| University of Illinois Medical Center Chicago, Illinois | |
| University of Iowa Hospitals and Clinics Iowa City, Iowa | |
| University of Kansas Medical Center Kansas City, Kansas | |
| University of Kentucky Lexington, Kentucky | |
| University of Maryland - Greenebaum Comprehensive Cancer Center Baltimore, Maryland | |
| University of Massachusetts Worcester, Massachusetts | |
| University of Miami Sylvester Cancer Center Miami, Florida | |
| University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan | |
| University of Nebraska Medical Center Omaha, Nebraska | |
| University of North Carolina at Chapel Hill Chapel Hill, North Carolina | |
| University of Pennsylvania Philadelphia, Pennsylvania | |
| University of Utah - Huntsman Cancer Institute Salt Lake City, Utah | |
| University of Virginia Charlottesville, Virginia | |
| VCU Massey Cancer Center Richmond, Virginia | |
| Virginia Commonwealth University Richmond, Virginia | Hall, Charles, E. - (hallce3@vcu.edu) |
| Washington Univ School of Medicine Siteman Cancer Center Saint Louis, Missouri | |
| West Virginia University - Berkeley Medical Center - Cancer and Infusion Center Morgantown, West Virginia | |
| Winship Cancer Institute of Emory University Atlanta, Georgia | |
| Yale Cancer Center New Haven, Connecticut |
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
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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
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Show 166 locations
Study Locations
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| Location | Contacts |
|---|---|
| A.O.U. CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO - Ospedale Molinette /ID# 256808 Turin, Piedmont | |
| AOU Policlinico G. Rodolico - San Marco /ID# 256814 Catania, | |
| ASST Ovest Milanese /ID# 256813 Legnano, Milano | |
| AZ Sint-Jan Brugge /ID# 245345 Bruges, West-Vlaanderen | |
| Addenbrookes Hospital /ID# 261104 Cambridge, Cambridgeshire | |
| Alberts Cellular Therapy /ID# 245725 Pretoria, Gauteng | |
| Alexandra General Hospital /ID# 240591 Athens, Attica | |
| Algemeen Ziekenhuis klina /ID# 260856 Brasschaat, Antwerpen | |
| Alta Bates Summit Medical Center for Research /ID# 261438 Berkeley, California | |
| Anjo Kosei Hospital /ID# 263434 Anjo, Aichi-ken | |
| Antalya Egitim Ve Arastirma Hastanesi /ID# 261674 Antalya, | |
| Atrium Health Levine Cancer Institute /ID# 246199 Charlotte, North Carolina | |
| Auxilio Mutuo Cancer Center /ID# 272565 San Juan, | |
| Azienda Ospedaliero Universitaria delle Marche /ID# 256812 Ancona, | |
| Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 256810 Rome, Roma | |
| Baptist Memorial Hospital /ID# 270910 Memphis, Tennessee | |
| Barbara Ann Karmanos Cancer Institute - McLaren Greater Lansing /ID# 259891 Lansing, Michigan | |
| Beijing Chaoyang Hospital,Capital Medical University /ID# 245533 Beijing, Beijing Municipality | |
| Beth Israel Deaconess Medical Center /ID# 271535 Boston, Massachusetts | |
| Box Hill Hospital /ID# 262784 Melbourne, Victoria | |
| CH Henri Duffaut /ID# 261844 Avignon, Vaucluse | |
| Calvary Mater Newcastle /ID# 261804 Waratah, New South Wales | |
| Cancer Specialists of North Florida - Jacksonville - AC Skinner Parkway /ID# 246230 Jacksonville, Florida | |
| Cedars-Sinai Medical Center /ID# 261008 Los Angeles, California | |
| Center for Cancer and Blood Disorders-American Oncology Partners of Maryland /ID# 263637 Bethesda, Maryland | |
| Centre Hospitalier Régional d'Orléans - Hôpital de la Source /ID# 261854 Orléans, | |
| Centre Hospitalier du Mans /ID# 261852 Le Mans, Sarthe | |
| Centrum fuer Haematologie und Onkologie Bethanien /ID# 271982 Frankfurt am Main, | |
| Ch Saint Quentin /Id# 261856 Saint-Quentin, Aisne | |
| Charite Universitaetsklinikum Berlin - Campus Benjamin Franklin /ID# 260689 Berlin, | |
| Chiba University Hospital /ID# 262006 Chiba, Chiba | |
| China Medical University Hospital /ID# 245483 Taichung, | |
| Chugoku Central Hospital /ID# 263431 Fukuyama, Hiroshima | |
| Cleveland Clinic Main Campus /ID# 246183 Cleveland, Ohio | |
| Complejo Hospitalario Universitario Ourense /ID# 246400 Ourense, Ourense | |
| Constantiaberg Haematology /ID# 261320 Cape Town, Western Cape | |
| Dana-Farber Cancer Institute /ID# 261554 Boston, Massachusetts | |
| Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi /ID# 261672 Ankara, | |
| Duke University Medical Center /ID# 259694 Durham, North Carolina | |
| Dup_Guys and St Thomas NHS Foundation Trust - Guy's Hospital /ID# 262488 London, Greater London | |
| Eastchester Center for Cancer Care /ID# 262952 The Bronx, New York | |
| Fakultni Nemocnice Ostrava /ID# 245686 Ostrava, Ostrava-mesto | |
| Fakultní Nemocnice Brno - Jihlavská /ID# 245689 Brno, Brno-mesto | |
| Fakultní nemocnice Hradec Králové - Sokolská /ID# 245690 Hradec Králové, Hradec Kralove | |
| Falu Lasarett /ID# 262231 Falun, | |
| First Affiliated Hospital of China Medical University /ID# 245547 Shenyang, Liaoning | |
| Fujian Medical University Union Hospital /ID# 245558 Fuzhou, Fujian | |
| Fundacao Champalimaud /ID# 246258 Lisbon, Lisbon District | |
| General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 240596 Athens, | |
| General University Hospital of Thessaloniki AXEPA /ID# 240595 Thessaloniki, | |
| Gifu Municipal Hospital /ID# 263321 Gifu, Gifu | |
| Gunma University Hospital /ID# 262580 Maebashi, Gunma | |
| Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz /ID# 261648 Győr, Győr-Moson-Sopron | |
| Haemalife Inc. /ID# 245724 Kuils River, Western Cape | |
| Helsingborgs Lasarett /ID# 262513 Helsingborg, Skåne County | |
| Hematology And Oncology Institute /ID# 272531 Manatí, | |
| Henan Cancer Hospital /ID# 245536 Zhengzhou, Henan | |
| Henry Ford Hospital /ID# 262704 Detroit, Michigan | |
| Hospital General Universitario Gregorio Maranon /ID# 246401 Madrid, | |
| Hospital Universitario de Salamanca /ID# 262218 Salamanca, | |
| Hospital Universitario y Politecnico La Fe /ID# 261625 Valencia, | |
| Hospital de Leon /ID# 261624 León, | |
| Hyogo Prefectural Amagasaki General Medical Center /ID# 265696 Amagasaki, Hyōgo | |
| Institute of Hematology and Blood Diseases Hospital /ID# 265702 Tianjin, Tianjin Municipality | |
| Instituto Catalan de Oncologia (ICO) Badalona /ID# 246398 Badalona, Barcelona | |
| Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE /ID# 246257 Porto, | |
| Istanbul Florence Nightingale Hospital /ID# 271543 Şişli, | |
| Japanese Red Cross Medical Center /ID# 261717 Shibuya-ku, Tokyo | |
| Karmanos Cancer Institute - Detroit /ID# 266298 Detroit, Michigan | |
| Klinik Ottakring /ID# 245829 Vienna, Vienna | |
| Klinikum Chemnitz - Flemmingstraße /ID# 273108 Chemnitz, Saxony | |
| Kyushu University Hospital /ID# 264704 Fukuoka, Fukuoka | |
| Leeds Teaching Hospitals NHS Trust /ID# 261101 Leeds, West Yorkshire | |
| Liverpool Hospital /ID# 262159 Liverpool, New South Wales | |
| Mayo Clinic - Rochester /ID# 246228 Rochester, Minnesota | |
| Mayo Clinic Hospital - Phoenix /ID# 263326 Phoenix, Arizona | |
| Mayo Clinic Hospital Jacksonville /ID# 263324 Jacksonville, Florida | |
| Medical University of South Carolina /ID# 259692 Charleston, South Carolina | |
| Medizinische Universitaet Graz /ID# 261908 Graz, Styria | |
| Miyagi Cancer Center /ID# 265094 Natori-shi, Miyagi | |
| Monash Health - Monash Medical Centre /ID# 262158 Clayton, Victoria | |
| Nagoya City University Hospital /ID# 263320 Nagoya, Aichi-ken | |
| Naha City Hospital /ID# 263972 Naha, Okinawa | |
| Nancy W. Knowles Cancer Center /ID# 271361 Elmhurst, Illinois | |
| National Taiwan University Hospital /ID# 245482 Taipei City, Taipei | |
| Nebraska Cancer Specialists - Omaha - Wright Street /ID# 276772 Omaha, Nebraska | |
| New York Cancer & Blood Specialists - Bay Shore /ID# 261524 Bay Shore, New York | |
| New York Cancer & Blood Specialists - Lake Success Medical Oncology /ID# 262953 New Hyde Park, New York | |
| New York Cancer and Blood Specialists - New York /ID# 262951 New York, New York | |
| Northwest Medical Specialties Tacoma /ID# 276281 Tacoma, Washington | |
| Nottingham City Hospital /ID# 261105 Nottingham, Nottinghamshire | |
| Odense University Hospital /ID# 260924 Odense, Region Syddanmark | |
| Oncology Consultants /ID# 276774 Houston, Texas | |
| Ordensklinikum Linz GmbH Elisabethinen /ID# 245609 Linz, Upper Austria | |
| Oregon Medical Research Center /ID# 262335 Portland, Oregon | |
| Our Lady Of The Lake Regional Medical Center /ID# 272780 Baton Rouge, Louisiana | |
| Peking Union Medical College Hospital (East) - Dongdan Campus /ID# 245545 Beijing, Beijing Municipality | |
| People's Hospital of Henan Province /ID# 260918 Zhengzhou, Henan | |
| Princess Alexandra Hospital /ID# 261810 Woolloongabba, Queensland | |
| Providence - St. Jude Medical Center /ID# 262031 Fullerton, California | |
| Rabin Medical Center. /ID# 245498 Petah Tikva, | |
| Regents of the University of Michigan /ID# 261577 Ann Arbor, Michigan | |
| Rocky Mountain Cancer Centers - Lone Tree /ID# 278320 Lone Tree, Colorado | |
| Rush University Medical Center /ID# 265690 Chicago, Illinois | |
| Saitama Prefectural Cancer Center /ID# 262586 Kitaadachi-gun, Saitama | |
| Samsung Medical Center /ID# 245492 Seoul, Seoul Teugbyeolsi | |
| Second Affiliated Hospital of Xian Jiaotong University /ID# 261255 Xi'an, Shaanxi | |
| Semmelweis Egyetem /ID# 261646 Budapest, | |
| Semmelweis Egyetem /ID# 261647 Budapest, | |
| Seoul National University Hospital /ID# 245491 Seoul, Seoul Teugbyeolsi | |
| Shaare Zedek Medical Center /ID# 245681 Jerusalem, Jerusalem | |
| Shanghai Tongji Hospital /ID# 245539 Shanghai, Shanghai Municipality | |
| Sir Run Run Shaw Hospital Zhejiang University School of Medicine /ID# 260882 Hangzhou, Zhejiang | |
| Springfield Clinic - First /ID# 262266 Springfield, Illinois | |
| St George Hospital /ID# 261806 Kogarah, New South Wales | |
| St Vincent's Hospital Melbourne /ID# 261808 Fitzroy Melbourne, Victoria | |
| Staedtisches Klinikum Karlsruhe /ID# 272377 Karlsruhe, Baden-Wurttemberg | |
| Sun Yat-Sen University Cancer Center /ID# 245542 Guangzhou, Guangdong | |
| Taichung Veterans General Hospital /ID# 261142 Taichung, | |
| Tel Aviv Sourasky Medical Center /ID# 245495 Tel Aviv, Tel Aviv | |
| Texas Oncology - Northeast Texas /ID# 278304 Tyler, Texas | |
| The Catholic University of Korea, Seoul St. Marys Hospital /ID# 245493 Seoul, Seoul Teugbyeolsi | |
| The Chaim Sheba Medical Center /ID# 245497 Ramat Gan, Tel Aviv | |
| The Christie Hospital /ID# 261102 Manchester, | |
| The First Affiliated Hospital of Nanchang University /ID# 245537 Nanchang, Jiangxi | |
| The First Affiliated Hospital of Soochow University /ID# 245544 Suzhou, Jiangsu | |
| The First Affiliated Hospital of Wenzhou Medical University /ID# 245550 Wenzhou, Zhejiang | |
| The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 260883 Hangzhou, Zhejiang | |
| The Royal Marsden NHS Foundation Trust /ID# 262470 London, | |
| The University of Osaka Hospital /ID# 263974 Suita-shi, Osaka | |
| The West Clinic /ID# 262444 Memphis, Tennessee | |
| Tianjin Medical University General Hospital /ID# 260851 Tianjin, Tianjin Municipality | |
| Tokyo Metropolitan Komagome Hospital /ID# 277567 Bunkyo Ku, Tokyo | |
| Trakya University Medical Facu /ID# 261673 Edirne, Istanbul, | |
| Uddevalla sjukhus /ID# 262034 Uddevalla, Västra Götaland County | |
| Ulsan University Hospital /ID# 245490 Ulsan, Ulsan Gwang Yeogsi | |
| Unidade Local de Saude de Santa Maria, EPE /ID# 246255 Lisbon, | |
| Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 245549 Wuhan, Hubei | |
| Universitaetsklinikum Freiburg /ID# 262147 Freiburg im Breisgau, Baden-Wurttemberg | |
| Universitaetsklinikum Hamburg-Eppendorf /ID# 260651 Hamburg, | |
| Universitaetsklinikum Krems /ID# 261509 Krems, Lower Austria | |
| University General Hospital Attikon /ID# 240592 Athens, Attica | |
| University Health Network_Princess Margaret Cancer Centre /ID# 261566 Toronto, Ontario | |
| University Hospital Kyoto Prefectural University of Medicine /ID# 262585 Kyoto, Kyoto | |
| University Of Cincinnati Medical Center /ID# 246415 Cincinnati, Ohio | |
| University of Alabama at Birmingham - Main /ID# 261434 Birmingham, Alabama | |
| University of Fukui Hospital /ID# 264222 Yoshida-gun, Fukui | |
| University of Illinois Hospital and Health Sciences System /ID# 246349 Chicago, Illinois | |
| University of Missouri Hospital /ID# 261553 Columbia, Missouri | |
| University of North Carolina /ID# 259854 Chapel Hill, North Carolina | |
| University of Tennessee Health Science Center /ID# 261622 Memphis, Tennessee | |
| University of Yamanashi Hospital /ID# 262912 Chuo-shi, Yamanashi | |
| Uniwersytecki Szpital Kliniczny Nr 1 w Lublinie /ID# 260168 Lublin, Lublin Voivodeship | |
| Uniwersytecki Szpital Kliniczny We Wroclawiu /ID# 260172 Wroclaw, Lower Silesian Voivodeship | |
| Uniwersyteckie Centrum Kliniczne /ID# 260169 Gdansk, Pomeranian Voivodeship | |
| VA Loma Linda Healthcare System /ID# 261015 Loma Linda, California | |
| VCU Massey Cancer Center: Dalton Oncology Clinic /ID# 261944 Richmond, Virginia | |
| Vanderbilt University Medical Center /ID# 261621 Nashville, Tennessee | |
| Vejle Sygehus /ID# 260923 Vejle, Region Syddanmark | |
| Virginia Cancer Specialists - Fairfax /ID# 262792 Fairfax, Virginia | |
| Virginia Oncology Associates - Norfolk (Lake Wright) /ID# 278314 Norfolk, Virginia | |
| Vseobecna fakultni nemocnice v Praze /ID# 245691 Prague, Praha 17 | |
| Western General Hospital - NHS Lothian /ID# 261106 Edinburgh, Edinburgh, City of | |
| Winship Cancer Institute of Emory University /ID# 262525 Atlanta, Georgia | |
| Yonsei University Health System Severance Hospital /ID# 245489 Seoul, | |
| Zhongda Hospital Southeast University /ID# 245563 Nanjing, Jiangsu |
A Study to Evaluate Preventive Treatments for GPRC5D-related Oral Events (Talisman)
Study Contact - Participate-In-This-Study1@its.jnj.com
NCT06500884
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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 study treatment, 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 indicating severe dysgeusia at screening and confirmed prior to randomization. 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, DRUG: Prophylaxis D, DRUG: Ramantamig
Multiple Myeloma
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Show 38 locations
Study Locations
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| Location | Contacts |
|---|---|
| Albert Schweitzer Ziekenhuis Dordrecht, | |
| Belfast City Hospital Belfast, Northern Ireland | |
| Clinica Medica Sao Germano S/S LTDA São Paulo, | |
| Colchester Hospital University NHS Colchester, | |
| Colorado Blood Cancer Institute Denver, Colorado | |
| Duke University Medical Center Durham, North Carolina | |
| Eastbourne District General Hospital Eastbourne, | |
| Erasmus MC Rotterdam, South Holland | |
| Fundação Universidade de Caxias do Sul Caxias do Sul, | |
| Hammersmith Hospital London, | |
| Hosp Clinic de Barcelona Barcelona, | |
| Hosp Clinico Univ de Salamanca Salamanca, | |
| Hosp. Quiron Madrid Pozuelo Pozuelo de Alarcón, | |
| Hosp. Univ. 12 de Octubre Madrid, | |
| Hosp. Univ. Germans Trias I Pujol Badalona, | |
| Hosp. Univ. Ramon Y Cajal Madrid, | |
| Hosp. Univ. Virgen de La Arrixaca El Palmar, | |
| Hosp. de Jerez de La Frontera Jerez de la Frontera, | |
| Hospitais Integrados da Gavea SA DF Star Brasília, | |
| Hospital Erasto Gaertner- Liga Paranaense de Combate ao Câncer Curitiba, | |
| Hospital Espanol Auxilio Mutuo Auxilio Mutuo Cancer Center San Juan, | |
| Icahn School of Medicine at Mt. Sinai New York, New York | |
| Instituto D Or de Pesquisa e Ensino Brasília, | |
| Instituto D Or de Pesquisa e Ensino IDOR São Paulo, | |
| Newcastle Freeman Hospital Newcastle upon Tyne, | |
| Samsung Medical Center Seoul, | |
| Seoul National University Hospital Seoul, | |
| The Catholic University of Korea Seoul St Mary s Hospital Seoul, | |
| The Christie NHS Foundation Trust Christie Hospital Manchester, | |
| The Clatterbridge Cancer Centre Liverpool, | |
| University College London Hospitals London, | |
| University Hospitals Cleveland Medical Center Cleveland, Ohio | |
| University of California San Francisco San Francisco, California | |
| University of Rochester Medical Center Rochester, New York | |
| University of Washington Seattle, Washington | |
| VUmc Amsterdam Amsterdam, | |
| Virginia Commonwealth University - Massey Cancer Center Richmond, Virginia | |
| Yale University School of Medicine New Haven, Connecticut |
A Study of Teclistamab in Combination With Daratumumab and Lenalidomide (Tec-DR) and Talquetamab in Combination With Daratumumab and Lenalidomide (Tal-DR) in Participants With Newly Diagnosed Multiple Myeloma (MajesTEC-7)
Study Contact - Participate-In-This-Study1@its.jnj.com
NCT05552222
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Inclusion Criteria:
* Have a diagnosis of multiple myeloma according to the International Myeloma Working Group (IMWG) diagnostic criteria
* Be newly diagnosed and not considered a candidate for high-dose chemotherapy with autologous stem cell transplant (ASCT) due to: ineligible due to advanced age OR; ineligible due to the presence of comorbid condition(s) likely to have a negative impact on tolerability of high-dose chemotherapy with ASCT OR; deferral of high-dose chemotherapy with ASCT as initial treatment
* Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2
* A participant must agree not to be pregnant, breastfeeding, or planning to become pregnant while enrolled in this study or within 6 months after the last dose of study treatment
* A participant must agree not to plan to father a child while enrolled in this study or within 100 days after the last dose of study treatment
Exclusion Criteria:
* Received any prior therapy for multiple myeloma or smoldering myeloma other than a short course of corticosteroids (not to exceed total of 160 milligrams \[mg\] dexamethasone or equivalent). In addition, received a cumulative dose of systemic corticosteroids equivalent to greater than or equals to (\>=) 20 mg of dexamethasone within 14 days before randomization
* Had plasmapheresis within 28 days of randomization
* Had a stroke, transient ischemic attack, or seizure within 6 months prior to randomization
* Known allergies, hypersensitivity, or intolerance to teclistamab or talquetamab excipients
* Known contraindications to the use of daratumumab or lenalidomide per local prescribing information
* Myeloma Frailty Index of \>=2 with the exception of participants who have a score of 2 based on age alone DRUG: Teclistamab, DRUG: Daratumumab, DRUG: Lenalidomide, DRUG: Dexamethasone, DRUG: Talquetamab
Multiple Myeloma
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Show 263 locations
Study Locations
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| Location | Contacts |
|---|---|
| A O U Sant Orsola Malpighi Bologna, | |
| ASST Papa Giovanni XXIII Bergamo Bergamo, | |
| AZ Groeninge Kortrijk, | |
| Aalborg University Hospital Aalborg, | |
| Addenbrooke's Hospital Cambridge, | |
| AdventHealth Medical Group Blood & Marrow Transplant at Orlando Orlando, Florida | |
| Alexander T. Augusta Military Medical Center Fort Belvoir, Virginia | |
| Alexandra General Hospital of Athens Athens, Attikí | |
| Allegheny Health Network Pittsburgh, Pennsylvania | |
| Ankara Universitesi Tip Fakultesi Cebeci Arastirma ve Uygulama Hastanesi Ankara, | |
| Arthur J E Child Comprehensive Cancer Centre Calgary, Alberta | |
| Asan Medical Center Seoul, | |
| Astera Cancer Care East Brunswick, New Jersey | |
| Atrium Health Wake Forest Baptist Comprehensive Cancer Center Winston-Salem, North Carolina | |
| Azienda Ospedaliera Universitaria Città della Salute e della Scienza di Torino Torino, | |
| Azienda Ospedaliera di Rilievo Nazionale A Cardarelli Naples, | |
| Banner MD Anderson Cancer Center Gilbert, Arizona | |
| Barwon Health - University Hospital Geelong Geelong, | |
| Beijing Chaoyang Hospital Chaoyang District, | |
| Beijing Tongren Hospital CMU Beijing, | |
| Blackpool Victoria Hospital Blackpool, | |
| British Columbia Cancer Agency Vancouver, British Columbia | |
| CHU Henri Mondor Créteil, | |
| CHU Hôpital Saint Antoine Paris, | |
| CHU Nantes Nantes, | |
| CHU Poitiers - Hopital la Miletrie Poitiers, | |
| CHU de Bordeaux - Hospital Haut-Leveque Pessac, | |
| CHU de Quebec L Hotel Dieu de Quebec Québec, Quebec | |
| CHU de Rennes - Hopital Pontchaillou Rennes, | |
| Calvary Mater Newcastle Hospital Waratah, New South Wales | |
| Cancer And Hematology Centers of Western Michigan PC Grand Rapids, Michigan | |
| Cancer and Blood Specialty Clinic Los Alamitos, California | |
| Careggi University Hospital Florence, | |
| Center For Cancer and Blood Disorders Bethesda, Maryland | |
| Centrum Onkologii Ziemi Lubelskiej im sw Jana z Dukli Lublin, | |
| Champalimaud Foundation Champalimaud Centre Lisbon, | |
| Changzhou No 2 Peoples Hospital Changzhou, | |
| Chiba Cancer Center Chiba, Chiba | |
| Chongqing University Cancer Hospital Chongqing, Chongqing Municipality | |
| Chonnam National University Hwasun Hospital Hwasun, | |
| ChristianaCare Helen F Graham Cancer Center and Research Institute Newark, Delaware | |
| Christus St. Vincent Regional Cancer Center Santa Fe, New Mexico | |
| City of Hope Duarte Duarte, California | |
| City of Hope Orange County Lennar Foundation Cancer Center Irvine, California | |
| City of Hope cancer Center Newnan, Georgia | |
| Cleveland Clinic Florida Weston, Florida | |
| Cleveland Clinic Main Campus Cleveland, Ohio | |
| Clinica Medica Sao Germano S/S LTDA São Paulo, | |
| Complexo Hospitalar de Niterói Niterói, | |
| Cross Cancer Institute Edmonton, Alberta | |
| Dartmouth Hitchcock Medical Center Lebanon, New Hampshire | |
| Dokuz Eylul University Medical Faculty Izmir, | |
| Dong-A University Hospital Busan, | |
| Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital Ankara, | |
| Durham VAMC Durham, North Carolina | |
| Fakultni Nemocnice Ostrava Ostrava-Poruba, | |
| Fakultni nemocnice Brno Brno, | |
| Fakultni nemocnice Hradec Kralove Hradec Králové, | |
| Fakultni nemocnice Olomouc Olomouc, | |
| Fakultni nemocnice Plzen PLZE, | |
| Falu Lasarett Falun, | |
| Fujian Meidical University Union Hospital Fuzhou, | |
| Fujita Health University Hospital Toyoake, Aichi-ken | |
| Fundacao Pio XII Barretos, São Paulo | |
| G Papanikolaou Hospital of Thessaloniki Thessalonikis, | |
| Gachon University Gil Medical Center Namdong-gu, Incheon-gwangyeoksi [incheon] | |
| Gelre Ziekenhuis Apeldoorn, | |
| Ghent University Hospital Ghent, | |
| Hanusch Krankenhaus Vienna, | |
| Harbin Medical University Cancer Hospital Harbin, Heilongjiang | |
| Helios Kliniken Berlin Buch Gmbh Berlin, | |
| Hematology-Oncology Associates of CNY East Syracuse, New York | |
| Henan Cancer Hospital Zhengzhou, Henan | |
| Henry Ford Cancer - Detroit Brigitte Harris Cancer Pavilion Detroit, Michigan | |
| Henry Ford Providence Novi Hospital Novi, Michigan | |
| Henry Ford Providence Southfield CK Potluri Cancer Center Southfield, Michigan | |
| Hopital Claude Huriez Lille, | |
| Hopitaux Universitaires de Strasbourg - Hopital de Hautepierre Strasbourg, | |
| Hosp Clinico Univ de Salamanca Salamanca, | |
| Hosp Univ Hm Sanchinarro Madrid, | |
| Hosp Univ Vall D Hebron Barcelona, | |
| Hosp. Clinico Univ. de Valencia Valencia, | |
| Hosp. Mutua Terrassa Terrassa, | |
| Hosp. Quiron Madrid Pozuelo Pozuelo de Alarcón, | |
| Hosp. Univ. 12 de Octubre Madrid, | |
| Hosp. Univ. Germans Trias I Pujol Badalona, | |
| Hosp. Univ. La Paz Madrid, | |
| Hosp. Univ. Son Espases Palma de Mallorca, | |
| Hosp. Univ. Virgen de Las Nieves Granada, | |
| Hosp. de Jerez de La Frontera Jerez de la Frontera, | |
| Hosp. de La Santa Creu I Sant Pau Barcelona, | |
| Hospices Civils de Lyon HCL Lyon, | |
| Hospital Das Clinicas Da Faculdade De Medicina Da USP São Paulo, | |
| Hospital Das Clinicas Da Faculdade De Medicina De RPUSP HCRP Ribeirão Preto, | |
| Hospital Nove de Julho São Paulo, | |
| Hospital Sao Rafael São Paulo, São Paulo | |
| Hospital de Clínicas de Porto Alegre Bairro Santa Cecília, Rio Grande do Sul | |
| Houston Methodist Hospital Houston, Texas | |
| Huntsman Cancer Institute Salt Lake City, Utah | |
| Hyogo Medical University Hospital Nishinomiya Shi, | |
| Imperial College Healthcare London, | |
| Inselspital Universitätsspital Bern Bern, | |
| Institut Catala d Oncologia L Hospitalet Barcelona, | |
| Institut Jules Bordet Anderlecht, | |
| Institut Universitaire du Cancer Toulouse Oncopole Toulouse, | |
| Institute of Hematology and Blood Diseases Hospital Tianjin, | |
| Instituto Portugues de Oncologia do Porto Francisco Gentil, E.P.E. Porto, | |
| Instituto do Cancer do Ceara Fortaleza, Ceará | |
| Irccs Policlinico San Matteo, Universita Degli Studi Di Pavi Pavia, | |
| Istituto Clinico Humanitas Rozzano (MI), | |
| Japanese Red Cross Medical Center Shibuya-ku, | |
| Joe Arrington Cancer Research Treatment Center Lubbock, Texas | |
| Johns Hopkins University School of Medicine JHUSOM Baltimore, Maryland | |
| Jolimont Haine-St-Paul, | |
| Juntendo University Hospital Bunkyō-Ku, Tokyo | |
| Kameda Medical Center Chiba, | |
| Kanazawa University Hospital Kanazawa, | |
| Kansai Medical University Hospital Hirakata, Osaka | |
| Kantonsspital St Gallen Sankt Gallen, | |
| Karolinska University Hospital Huddinge Stockholm, | |
| Kent and Canterbury Hospital Canterbury, | |
| Klinikum Nuernberg Nord Nuremberg, | |
| Kumamoto University Hospital Kumamoto, Kumamoto | |
| Kyungpook National University Hospital Daegu, | |
| LSUHSC Shreveport Feist-Weiller Cancer Center Shreveport, Louisiana | |
| Levine Cancer Institute Charlotte, North Carolina | |
| Liga Norte Riograndense Contra O Cancer Natal, | |
| Liga Paranaense de Combate ao Cancer Curitiba, | |
| Liv Hospital Ankara Ankara, | |
| Liverpool Hospital Liverpool, New South Wales | |
| Matsuyama Red Cross Hospital Matsuyama, Ehime | |
| Med. Universitatsklinik Essen Essen, | |
| Medical University Vienna Vienna, | |
| Medipol Mega Universite Hastanesi Istanbul, | |
| Memorial Antalya Hospital Antalya, | |
| Memorial Sloan Kettering Cancer Center New York, New York | |
| NYU Langone Hospital Long Island Mineola, New York | |
| Nanfang Hospital Guangzhou, | |
| Nanjing Drum Tower Hospital Nanjing, | |
| National Cancer Center Goyang-si, Kyǒnggi-do | |
| National Hospital Organization Hokkaido Cancer Center Sapporo, Hokkaido | |
| National Hospital Organization Mito Medical Center Higashiibaraki, Ibaraki | |
| National Hospital Organization Nagasaki Medical Center Nagasaki, | |
| National Hospital Organization Okayama Medical Center Okayama, | |
| National Hospital Organization Shibukawa Medical Center Shibukawa, | |
| Nebraska Cancer Specialists Omaha, Nebraska | |
| New Cross Hospital Wolverhampton, | |
| No.1 Affiliated Hospital, Medical College of Zhejiang University Hangzhou, | |
| Northwell Health Cancer Institute Lake Success, New York | |
| Northwest Medical Specialties, PLLC Tacoma, Washington | |
| Norton Cancer Institute Louisville, Kentucky | |
| Novant Health Winston-Salem, North Carolina | |
| Novant Health Forsyth Medical Center Winston-Salem, North Carolina | |
| Novant Health Zimmer Cancer Institute Wilmington, North Carolina | |
| OhioHealth Columbus, Ohio | |
| Oncology Hematology Care Cincinnati, Ohio | |
| Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi Samsun, | |
| Ordensklinikum Linz GmbH Elisabethinen Linz, | |
| Osaka Metropolitan University Hospital Osaka, Osaka | |
| Oslo University Hospital HF Ulleval sykehus Oslo, | |
| Ospedale San Raffaele Milan, | |
| Pamukkale University Medical Faculty Denizli, | |
| Peking Union Medical College Hospital Beijing, Beijing Municipality | |
| Peking University First Hospital Beijing, Beijing Municipality | |
| Peking University Shenzhen Hospital Shenzhen, Guangdong | |
| Penn State Milton S Hershey Medical Ctr Hershey, Pennsylvania | |
| Perlmutter Cancer Center at NYU Langone Health New York, New York | |
| Pratia Onkologia Katowice Katowice, | |
| Princess Alexandra Hospital Woolloongabba, Queensland | |
| Pusan National University Hospital Seogu, Busan Gwang'yeogsi | |
| Qilu Hospital of Shandong University Jinan, | |
| Rabin Petah Tikva, | |
| Rambam Medical Center Haifa, Ḥeifā | |
| Regionshospitalet Godstrup Herning, | |
| Reinier de Graaf Gasthuis Delft, | |
| Renji Hospital, Shanghai Jiaotong University School of Medicine Shanghai, | |
| Richmond VA Medical Center Richmond, Virginia | |
| Royal Prince Alfred Hospital Camperdown, New South Wales | |
| Ruijin Hospital Shanghai Jiao Tong University Shanghai, | |
| SCRI CCCIT gem GmbH Salzburg, | |
| Saitama Medical University Hospital Saitama, | |
| Samsung Medical Center Seoul, | |
| Santa Casa de Misericordia de Belo Horizonte Belo Horizonte, | |
| Seoul National University Hospital Seoul, | |
| Severance Hospital Yonsei University Health System Seoul, Seoul-teukbyeolsi [Seoul] | |
| Shaare Zedek Medical Center Jerusalem, Jerusalem | |
| Shanghai Fourth People s Hospital Shanghai, | |
| Sheba Medical Center Ramat Gan, Central District | |
| Shengjing Hospital of China Medical University Shenyang, | |
| Shizuoka Cancer Center Nakatogari, Shizuoka | |
| Sichuan Provincial Peoples Hospital Chengdu, | |
| Sir Charles Gairdner Hospital Nedlands, Western Australia | |
| Skanes universitetssjukhus Lund, | |
| Soroka Medical Center Beersheba, Southern District | |
| St. Antonius Ziekenhuis Nieuwegein Nieuwegein, | |
| St. Olavs Hospital Trondheim, | |
| Sun Yat -Sen University Cancer Center Guangzhou, | |
| Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach Kielce, | |
| Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im Ks B Markiewicza Brzozów, | |
| Szpital Uniwersytecki im Karola Marcinkowskiego w Zielonej Gorze Zielona Góra, | |
| Szpital Uniwersytecki nr 2 im. Jana Biziela w Bydgoszczy Bydgoszcz, | |
| Tel Aviv Sourasky Medical Center Tel Aviv, | |
| The Catholic University of Korea Seoul St Mary s Hospital Seoul, | |
| The Christ Hospital Cancer Center Cincinnati, Ohio | |
| The First Affiliated Hospital of Guangxi Medical University Nanning, Guangxi | |
| The First Affiliated Hospital of Wenzhou Medical University Wenzhou, Zhejiang | |
| The First Affiliated Hospital of Xiamen University Xiamen, Fujian | |
| The First Affliated Hospital Of Nanchang University Nanchang, | |
| The Ohio State University- James Cancer Hospital Columbus, Ohio | |
| The Second Affiliated Hospital of Xi'an Jiaotong University Xi'an, | |
| The Second Affiliated Hospital of Zhejiang University Hangzhou, | |
| The Second Xiangya Hospital of Central South Hospital Changsha, | |
| Theageneio Cancer Hospital Thessaloniki, | |
| Tianjin Medical University Cancer Institute and Hospital Tianjin, Tianjin Municipality | |
| Tokai University Hospital Iseharashi, Kanagawa | |
| UCSF Fresno Clovis, California | |
| Uls Braga - Hosp. Braga Braga, | |
| Uls Hosp Sao Joao Porto, | |
| Universita Degli Studi di Roma Tor Vergata Roma, | |
| Universitaetsklinik Hamburg-Eppendorf Hamburg, | |
| Universitaetsklinikum Halle Saale Halle, | |
| Universitaetsklinikum Tuebingen der Eberhard-Karls-Universitaet, Abteilung fuer Innere Medizin II, Tübingen, | |
| Universitaetsklinikum Wuerzburg Würzburg, | |
| Universitair Ziekenhuis Leuven Leuven, | |
| Universitetssjukhuset Örebro Örebro, | |
| University College London Hospitals London, | |
| University Hospitals Birmingham NHS Foundation Trust Birmingham, | |
| University Hospitals Bristol and Weston Bristol, | |
| University Hospitals Cleveland Medical Center Cleveland, Ohio | |
| University of Arizona Cancer Center Tucson, Arizona | |
| University of Cincinnati Cincinnati, Ohio | |
| University of Connecticut Farmington, Connecticut | |
| University of Illinois Medical Center Chicago, Illinois | |
| University of Iowa Health Care Waukee, Iowa | |
| University of Michigan Ann Arbor, Michigan | |
| University of Nebraska Medical Center Omaha, Nebraska | |
| University of Texas Southwestern Medical Center Dallas, Texas | |
| University of Virginia Charlottesville, Virginia | |
| Uniwersytecki Szpital Kliniczny Nr 1 w Lublinie Lublin, | |
| Uniwersytecki Szpital Kliniczny W Poznaniu Poznan, | |
| Uniwersyteckie Centrum Kliniczne Gdansk, | |
| Utah Cancer Specialists Salt Lake City, Utah | |
| VFN v Praze Prague, | |
| VUmc Amsterdam Amsterdam, | |
| Valkyrie Clinical Trials Los Angeles, California | |
| Vejle Sygehus Vejle, Region Syddanmark | |
| Virginia Commonwealth University Medical Center Richmond, Virginia | |
| Virginia Oncology Associates Brock Cancer Center Norfolk, Virginia | |
| Weill Cornell Medical College New York, New York | |
| Western General Hospital Edinburgh, Midlothian | |
| Wojewodzki Szpital Kliniczny w Bialej Podlaskiej Biała Podlaska, | |
| Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im M Kopernika w Lodzi Lodz, | |
| Wollongong Hospital Wollongong, New South Wales | |
| Wuhan Tongji Hospital Tongji Medical College Wuhan, | |
| Yale New Haven Hospital New Haven, Connecticut | |
| Yamagata University Hospital Yamagata, Yamagata | |
| Yamanashi Prefectural Central Hospital Yamanashi, | |
| ZAS Augustinus Antwerp, | |
| ZAS Cadix Antwerp, | |
| Zealand University Hospital Roskilde, | |
| Zhongda Hospital Southeast University Nanjing, | |
| Zuyderland Medical Center Sittard-Geleen, | |
| the First Hospital of Jilin University Changchun, |
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
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| Location | Contacts |
|---|---|
| Virginia Commonwealth University Richmond, Virginia | Winter, Marcia - (mawinter@vcu.edu) |
A Multicenter Access and Distribution Protocol for Unlicensed Cryopreserved Cord Blood Units (CBUs)
Elizabeth Fosberg, B.A. - 10-CBA@ndmp.org
McCarty, John, M.
NCT01351545
HM13913
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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
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See this study on ClinicalTrials.gov
Show 142 locations
Study Locations
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| Location | Contacts |
|---|---|
| AdventHealth Orlando Orlando, Florida | Rushang Patel, MD - (rushang.patel.md@adventhealth.com) |
| Advocate Lutheran General Hospital Park Ridge, Illinois | |
| All Children's Hospital St. Petersburg, Florida | Deepakbabu Chellapandian, MD - (dchella2@jhmi.edu) |
| Amarillo Blood and Marrow Transplant Program Amarillo, Texas | |
| Ann & Robert H. Lurie Children's Hospital of Chicago Chicago, Illinois | Sonali Chaudhury, MD - (schaudhury@luriechildrens.org) |
| Arkansas Children's Hospital Little Rock, Arkansas | Jason Farrar, MD - (JEFarrar@uams.edu) |
| Avera Transplant Institute Sioux Falls, South Dakota | Waqas Jehangir, MD, FACP - (waqas.jehangir@avera.org) |
| Banner MD Anderson Cancer Center Gilbert, Arizona | Matthew Ulrickson, MD - (Matthew.Ulrickson@bannerhealth.com) |
| Beth Israel Deaconess Boston, Massachusetts | David Avigan, MD - (davigan@bidmc.harvard.edu) |
| Cardinal Glennon Children's Medical Center St Louis, Missouri | Deepika Bhatla, MD - (dbhatla@slu.edu) |
| Children's Healthcare of Atlanta Atlanta, Georgia | Ann Haight, MD - (Ann.haight@choa.org) |
| Children's Hospital Colorado Aurora, Colorado | Michael Verneris, MD - (MICHAEL.VERNERIS@CUANSCHUTZ.EDU) |
| Children's Hospital and Research Center of Oakland Oakland, California | |
| Children's Hospital at Montefiore The Bronx, New York | Mahvish Rahim, MD - (mrahim@montefiore.org) |
| Children's Hospital of Los Angeles Glendale, California | Neena Kapoor, MD - (nkapoor@chla.usc.edu) |
| Children's Hospital of Michigan Detroit, Michigan | Sureyya Savasan, MD - (ssavasan@med.wayne.edu) |
| Children's Hospital of New Orleans/LSUHSC New Orleans, Louisiana | Lolie Yu, MD - (lyu@lsuhsc.edu) |
| Children's Hospital of Orange County (CHOC) Orange, California | Rishikesh Chavan, MD - (rishikesh.chavan@choc.org) |
| Children's Hospital of Philadelphia Philadelphia, Pennsylvania | Timothy Olson, MD - (olsont@email.chop.edu) |
| Children's Hospital of Pittsburgh Pittsburgh, Pennsylvania | Paul Szabolcs, MD - (Paul.szabolcs@chp.edu) |
| Children's Hospital of Wisconsin Milwaukee, Wisconsin | David Margolis, MD - (dmargoli@mcw.edu) |
| Children's Medical Center Dallas Dallas, Texas | Victor Aquino, MD - (Victor.aquino@utsouthwestern.edu) |
| Children's Mercy Hospital and Clinics Kansas City, Missouri | |
| Children's National Medical Center Washington D.C., District of Columbia | David Jacobsohn, MD - (dajacobs@childrensnational.org) |
| Childrens Hospital Medical Center of Akron Akron, Ohio | Megan Sampson, MD - (msampson@akronchildrens.org) |
| Cincinnati Children's Hospital Cincinnati, Ohio | Stella Davies, MD - (stella.davies@cchmc.org) |
| City of Hope Duarte, California | Monzr Al Malki, MD - (malmalki@coh.org) |
| Cleveland Clinic Cleveland, Ohio | Claudio Brunstein, MD - (brunstc@ccf.org) |
| Cohen Children's Medical Center of New York New Hyde, New York | Jonathan Fish, MD - (jfish1@nshs.edu) |
| Columbia University Medical Center - Morgan Stanley Children's Hospital New York, New York | Monica Bhatia, MD - (mb2476@columbia.edu) |
| Cook Children's Hospital Fort Worth, Texas | Gretchen Eames, MD - (gretchen.eames@cookchildrens.org) |
| Dana Farber Cancer Institute Boston, Massachusetts | Corey Cutler, MD - (cscutler@partners.org) |
| Duke University Medical Center Durham, North Carolina | Joanne Kurtzberg, MD - (kurtz001@mc.duke.edu) |
| Emory University Hospital Atlanta, Georgia | |
| Florida Center for Pediatric Cellular Therapy Orlando, Florida | Susan Kelly, MD - (susan.kelly.md@flhosp.org) |
| Fred Hutchinson Cancer Research Center Seattle, Washington | Ann Dahlberg, MD - (adahlber@fredhutch.org) |
| Georgia Cancer Center at Augusta University Health Augusta, Georgia | Vamsi K Kota, MD - (vkota@augusta.edu) |
| Greenebaum Cancer Center - University of Maryland Baltimore, Maryland | |
| H Lee Moffitt Cancer Center Tampa, Florida | |
| Hackensack University Medical Center Hackensack, New Jersey | Alfred Gillio, MD - (agillio@humed.com) |
| Helen DeVos Children's Hospital Grand Rapids, Michigan | Troy Quigg, MD - (troy.quigg@spectrumhealth.org) |
| Henry Ford Health System Detroit, Michigan | Nalini Janakiraman, MD - (njanaki1@hfhs.org) |
| Indiana Blood & Marrow Transplantation Beech Grove, Indiana | |
| Indiana University/Riley Hospital for Children Indianapolis, Indiana | Jodi Skiles, MD - (jskiles@iupui.edu) |
| Johns Hopkins Baltimore, Maryland | Allen Chen, MD, PhD - (allenchen@jhmi.edu) |
| Kapiolani Medical Center for Women and Children Honolulu, Hawaii | Randal Wada, MD - (randalw@hawaii.edu) |
| Karmanos Cancer Institute Detroit, Michigan | |
| Levine Children's Hospital Charlotte, North Carolina | Jeffrey Huo, MD - (Jeffrey.Huo@carolinashealthcare.org) Michelle Hyland - (Michelle.Hyland@carolinashealthcare.org) |
| Loma Linda University Cancer Center Loma Linda, California | Hisham Abdel-Azim, MD - (habdelazim@llu.edu) |
| Loyola University Medical Center Maywood, Illinois | Patrick Hagen, MD - (patrick.hagen@lumc.edu) |
| M.D. Anderson Cancer Center Houston, Texas | Elizabeth Shpall, MD - (eshpall@mdanderson.org) |
| Massachusetts General Hospital Boston, Massachusetts | |
| Mayo Clinic - Jacksonville Jacksonville, Florida | |
| Mayo Clinic Arizona (adults) Phoenix, Arizona | James Slack, MD - (slack.james@mayo.edu) |
| Mayo Clinic Rochester Rochester, Minnesota | |
| Medical City Dallas Dallas, Texas | Vikas Bhushan, MD - (vikas.bhushan@usoncology.com) |
| Medical College of Wisconsin Milwaukee, Wisconsin | |
| Medical University of South Carolina Charleston, South Carolina | Michelle Hudspeth, MD - (hudspeth@musc.edu) |
| Memorial Sloan-Kettering Cancer Center New York, New York | Ann Jakubowski, MD - (jakubowa@mskcc.org) |
| Methodist Healthcare Blood and Marrow Transplant Center Memphis, Tennessee | |
| Methodist Healthcare System of San Antonio/Texas Transplant Institute San Antonio, Texas | Jose Cruz, MD - (josecarlos.cruz@hcahealthcare.com) |
| Midwestern Regional Medical Center Zion, Illinois | |
| Mount Sinai Medical Center - New York New York, New York | Alla Keyzner, MD - (alla.keyzner@mssm.edu) |
| NIH/NCI Bethesda, Maryland | |
| Nationwide Children's Hospital Columbus, Ohio | Rolla Abu-Arja, MD - (rolla.abu-arja@nationwidechildrens.org) |
| Nemours - Alfred I. duPont Hospital for Children Brandywine, Delaware | Emi Caywood, MD - (ecaywood@nemours.org) |
| Nemours Children's Hospital - Mayo Jacksonville Jacksonville, Florida | Edward Ziga, MD - (Edward.ziga@nemours.org) |
| New York Presbyterian Hospital at Cornell New York, New York | Tsiporah Shore, MD - (tbs2001@med.cornell.edu) |
| New York University Langone Medical Center New York, New York | Mohammad M Abdul Hay, MD - (maher.abdulhay@nyulangone.org) Antoine Mesidor - (Antoine.Mesidor@nyulangone.org) |
| Nih/Nhlbi Bethesda, Maryland | Richard Childs, MD - (childsr@nih.gov) |
| Nih/Niaid Bethesda, Maryland | Elizabeth Kang, MD - (ekang@niaid.nih.gov) |
| Niklaus Children's Hospital Miami, Florida | Jorge Galvez-Silva, MD - (jorgericardo.galvezsilva@nicklaushealth.org) |
| North Shore University Hospital Manhasset, New York | Ruthee L Bayer, MD - (rbayer@nshs.edu) |
| Northside Hospital Atlanta, Georgia | Scott Solomon, MD - (ssolomon@bmtga.com) |
| Northwestern Memorial Hospital Chicago, Illinois | Kehinde Adekola, MD - (kehinde-adekola@northwestern.edu) |
| Oregon Health & Science University/Doernbecher Children's Hospital Portland, Oregon | Eneida Nemecek, MD - (nemeceke@ohsu.edu) |
| Orlando Health Arnold Palmer Hospital for Children Orlando, Florida | Rikin Shah - (rikin.shah@orlandohealth.com) |
| Orlando Health Cancer Institute Bone Marrow Transplant and Cellular Therapy Orlando, Florida | Yasser Khaled, MD - (yasser.khaled@orlandohealth.com) |
| Penn State Milton S. Hershey Cancer Center Hershey, Pennsylvania | Shin Mineishi, MD - (smineishi@pennstatehealth.psu.edu) |
| Phoenix Children's Hospital Phoenix, Arizona | Dana Salzberg, MD - (dsalzberg@phoenixchildrens.com) |
| Presbyterian St. Luke's/Colorado Blood Cancer Institute Denver, Colorado | Alireza Eghtedar, MD - (alireza.eghtedar@healthonecares.com) |
| Rady Children's Hospital San Diego San Diego, California | Eric Anderson, MD - (eanderson@rchsd.org) |
| Robert Wood Johnson/Cancer Institute of New Jersey New Brunswick, New Jersey | Matthew Matasar, MD, MS - (mm3511@cinj.rutgers.edu) |
| Roger Williams Medical Center Providence, Rhode Island | Todd Roberts, MD - (todd.roberts@chartercare.org) |
| Roswell Park Cancer Institute Buffalo, New York | Kanwaldeep Mallhi, MD - (Kanwaldeep.Mallhi@RoswellPark.org) |
| Rush University Medical Center Chicago, Illinois | |
| Sarah Cannon BMT Program Nashville, Tennessee | |
| Scripps Green Hospital La Jolla, California | James R Mason, MD - (mason.james@scrippshealth.org) |
| Southwest Cancer Treatment & Research Center Lubbock, Texas | |
| Spectrum Health Grand Rapids, Michigan | Aly Abdel-Mageed, MD - (aly.mageed@helendevoschildrens.org) |
| St. Jude Childrens Research Hospital Memphis, Tennessee | Renee Madden, MD - (renee.madden@stjude.org) |
| St. Louis University Medical Center St Louis, Missouri | Sagun Goyal, MD - (sgoyal3@slu.edu) |
| Stanford University Medical Center Palo Alto, California | Andrew Rezvani, MD - (arezvani@stanford.edu) |
| Stony Brook University Hospital Stony Brook, New York | Michael Schuster, MD - (mschuster@notes.cc.sunysb.edu) |
| Strong Memorial Hospital/University of Rochester Rochester, New York | Omar Aljitawi, MD - (omar_aljitawi@urmc.rochester.edu) |
| Sutter Medical Center Sacramento, California | Elias Kiwan, MD - (elias.kiwan@sutterhealth.org) |
| Texas Children's Hospital - Baylor Medical Center Houston, Texas | George Carrum, MD - (gcarrum@houstonmethodist.org) |
| The Arthur G. James Cancer Hospital/The Ohio State University Medical Center Columbus, Ohio | Sumithira Vasu, MD - (sumithira.vasu@osumc.edu) |
| The Children's Hospital of San Antonio San Antonio, Texas | Martin Andreansky, MD, PhD - (martin.andreansky@bcm.edu) Mark Schambura - (Mark.schambura@christushealth.org) |
| The Jewish Hospital Cincinnati, Ohio | |
| Tufts Medical Center Boston, Massachusetts | Andreas Klein, MD - (aklein2@tuftsmedicalcenter.org) |
| Tulane Medical Center New Orleans, Louisiana | Hana Safa, MD - (hsafah@tulane.edu) |
| UCLA Santa Monica, California | Gary Schiller, MD - (gschiller@mednet.ucla.edu) |
| UCSF (adults) San Francisco, California | |
| UCSF (peds) San Francisco, California | Sandhya Kharbanda, MD - (sandhya.kharbanda@ucsf.edu) |
| Univeristy of Mississippi Medical Center Jackson, Mississippi | Carolyn Bigelow, MD - (cbigelow@umc.edu) |
| University Hospitals Case Medical Center Cleveland, Ohio | Hillard Lazarus, MD - (hillard.lazarus@case.edu) |
| University of Alabama at Birmingham Birmingham, Alabama | Joseph Chewning, MD - (jchewning@peds.uab.edu) |
| University of Arizona Medical Center - Tucson Tucson, Arizona | Emmanuel Katsanis, MD - (katsanis@peds.arizona.edu) |
| University of California San Diego San Diego, California | Kaitlyn Dykes, MD - (kcdykes@health.ucsd.edu) |
| University of Chicago Chicago, Illinois | James LaBelle, MD, PhD - (jlabelle@peds.bsd.uchicago.edu) |
| University of Colorado Hospital Aurora, Colorado | Jonathan Gutman, MD - (jonathan.gutman@ucdenver.edu) |
| University of Florida Shands Medical Center Gainesville, Florida | Jordan Milner, MD - (jordan.milner@ufl.edu) |
| University of Illinois at Chicago Chicago, Illinois | Damiano Rondelli, MD - (drond@uic.edu) |
| University of Iowa Iowa City, Iowa | Margarida Silverman, MD - (margarida-silverman@uiowa.edu) |
| University of Kansas Kansas City, Kansas | Joseph McGuirk, DO - (jmcguirk@kumc.edu) |
| University of Louisville Hospital - James Brown Cancer Center Louisville, Kentucky | Mohamed Hegazi, MD - (mohamed.hegazi@louisville.edu) |
| University of Massachusetts Worcester, Massachusetts | Jan Cerny, MD - (Jan.Cerny@umassmemorial.org) |
| University of Miami (adult) Miami, Florida | |
| University of Miami (peds) Miami, Florida | Edward Ziga, MD, MPH - (e.ziga@med.miami.edu) |
| University of Michigan Ann Arbor, Michigan | Jessica Yu - (jjxyu@med.umich.edu) |
| University of Nebraska Medical Center Omaha, Nebraska | Phyllis Warkenton, MD - (pwarkent@unmc.edu) |
| University of North Carolina at Chapel Hill Chapel Hill, North Carolina | Anson Snow, MD - (Anson.Snow@unchealth.unc.edu) |
| University of Oklahoma Health Science Center Oklahoma City, Oklahoma | Adam Asch, MD - (adam-asch@ouhsc.edu) |
| University of Pennsylvania/Thomas Jefferson Pittsburgh, Pennsylvania | Elizabeth Hexner, MD - (elizabeth.hexner@uphs.upenn.edu) |
| University of Pittsburgh Medical Center Pittsburgh, Pennsylvania | Alison Sehgal, MD - (sehgalar@upmc.edu) |
| University of Texas Southwestern Medical Center Dallas, Texas | |
| University of Utah Salt Lake City, Utah | Ahmad Rayes, MD - (ahmad.rayes@hsc.utah.edu) |
| University of Virginia Charlottesville, Virginia | Karen Ballen, MD - (KB3TC@hscmail.mcc.virginia.edu) |
| University of Wisconsin - Madison Madison, Wisconsin | Kenneth DeSantes, MD - (kbdesantes@pediatrics.wisc.edu) |
| VA Puget Sound HCS Seattle, Washington | |
| VA Tennessee Valley Healthcare System Nashville, Tennessee | |
| Vanderbilt University Nashville, Tennessee | Michael Byrne, MD - (michael.byrne@vumc.org) |
| Virginia Commonwealth University Richmond, Virginia | John McCarty, MD - (jmccarty@vcu.edu) |
| Wake Forest University Winston-Salem, North Carolina | |
| Washington University St. Louis St Louis, Missouri | Geoffrey Uy, MD - (guy@wustl.edu) |
| Washington University/St. Louis Children's Hospital St Louis, Missouri | Geoffrey Uy, MD - (guy@wustl.edu) |
| West Penn Hospital Pittsburgh, Pennsylvania | Prerna Mewawalla, MD - (pmewawalla26085@direct.ahn.org) |
| West Virginia University Morgantown, West Virginia | Lauren Veltri, MD - (lveltri@hsc.wvu.edu) |
| Westchester Medical Center Valhalla, New York | Mitchell Cairo, MD - (mitchell_cairo@nymc.edu) |
| Yale New Haven Hospital New Haven, Connecticut | Aaron Flagg, MD - (aron.flagg@yale.edu) |
| Zachary & Elizabeth Fisher Bone Marrow Transplant Program (Brooke Army Medical Center) Fort Sam Houston, Texas | Bradley Beeler, MD - (bradley.w.beeler.mil@health.mil) |
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
I'm interested
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See this study on ClinicalTrials.gov
Show 1 location
Study Locations
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| Location | Contacts |
|---|---|
| Virginia Commonwealth University Richmond, Virginia | Jewell, Andrea - (Andrea.Jewell@vcuhealth.org) |
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
I'm interested
Share via email
Show 1 location
Study Locations
Hide all locations
| Location | Contacts |
|---|---|
| Virginia Commonwealth University Richmond, Virginia | Hong, Susan - (susan.hong@vcuhealth.org) |