Spots Global Cancer Trial Database for MM CAR-T to Upgrade Response BMTCTN1902
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Trial Identification
Brief Title: MM CAR-T to Upgrade Response BMTCTN1902
Official Title: Phase II Multicenter Trial of Anti-BCMA CAR T-Cell Therapy for MM Patients With Sub-Optimal Response After Auto HCT and Maintenance Len. BMTCTN1902
Study ID: NCT05032820
Conditions
Interventions
Study Description
Brief Summary: This study is designed as a Phase II, multicenter, single arm trial to assess anti-B Cell Maturation Antigen (BCMA) chimeric antigen receptor (CAR) T-cells (bb2121) to improve post autologous hematopoietic cell transplant (HCT) responses among patients with multiple myeloma (MM).
Detailed Description: After meeting the eligibility criteria and enrolling on the trial, patients will undergo leukapheresis for collection of autologous lymphocytes, which will be sent to BMS/Celgene manufacturing facilities. Once cells have been manufactured, patients will then proceed to lymphodepleting chemotherapy with cyclophosphamide 300mg/m2 and fludarabine 30mg/m2 for 3 consecutive days followed by the infusion of BCMA CAR T-cells at a target dose of 450 x106 cells. Maintenance lenalidomide, starting at 10mg a day for 21 days of a 28-day cycle will be initiated at a minimum of at least 30 days, but no later than 180 days after the CAR T-cell infusion and will continue until the patient reaches 12 months post CAR T-cell infusion and continue free of progression
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
City of Hope National Medical Center, Duarte, California, United States
Stanford Hospital and Clinics, Palo Alto, California, United States
University of California, San Francisco, San Francisco, California, United States
H. Lee Moffitt Cancer Center, Tampa, Florida, United States
Loyola University Medical Center, Maywood, Illinois, United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
Roswell Park Cancer Center, Buffalo, New York, United States
Mount Sinai Medical Center, New York, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Duke University Medical Center, Durham, North Carolina, United States
University of Pennsylvania Hospital Center, Philadelphia, Pennsylvania, United States
Baylor College and Medicine, Houston, Texas, United States
University of Virginia, Charlottesville, Virginia, United States
University of Wisconsin Hospitals and Clinics, Madison, Wisconsin, United States
Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Contact Details
Name: Marcelo C Pasquini, MD, MS
Affiliation: Medical College of Wisconsin
Role: STUDY_DIRECTOR
Name: Alfred Garfall, MD
Affiliation: University of Pennsylvannia
Role: PRINCIPAL_INVESTIGATOR
Name: Sergio Giralt, MD
Affiliation: Memorial Sloan Kettering Cancer Center
Role: PRINCIPAL_INVESTIGATOR
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