Upfront Chimeric Antigen Receptor T-Cell to Upgrade Response in Multiple Myeloma

PHASE2CompletedINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

January 5, 2022

Primary Completion Date

August 22, 2024

Study Completion Date

February 20, 2025

Conditions
Multiple Myeloma
Interventions
DRUG

Lenalidomide

Maintenance lenalidomide, starting at 5 mg 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 participant reaches 12 months post CAR T-cell infusion and continues free of progression

BIOLOGICAL

bb2121

Participants receive infusion of BCMA CAR T-cells at a target dose of 450 x 10\^6 cells.

DRUG

Cyclophosphamide

300 mg/m\^2/day for 3 consecutive days prior to the CAR T infusion

DRUG

Fludarabine

30 mg/m\^2/day or 3 consecutive days prior to the CAR T infusion

PROCEDURE

leukapheresis

Placement of central line catheter and leukapheresis

Trial Locations (15)

10029

Mount Sinai Medical Center, New York

10065

Memorial Sloan Kettering Cancer Center, New York

14203

Roswell Park Cancer Center, Buffalo

19104

University of Pennsylvania Hospital Center, Philadelphia

22908

University of Virginia, Charlottesville

27705

Duke University Medical Center, Durham

33612

H. Lee Moffitt Cancer Center, Tampa

53226

Medical College of Wisconsin, Milwaukee

53792

University of Wisconsin Hospitals and Clinics, Madison

60153

Loyola University Medical Center, Maywood

77030

Baylor College and Medicine, Houston

91010

City of Hope National Medical Center, Duarte

94143

University of California, San Francisco, San Francisco

94305

Stanford Hospital and Clinics, Palo Alto

02215

Beth Israel Deaconess Medical Center, Boston

All Listed Sponsors
collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

collaborator

Blood and Marrow Transplant Clinical Trials Network

NETWORK

collaborator

National Cancer Institute (NCI)

NIH

collaborator

National Marrow Donor Program

OTHER

collaborator

Celgene a wholly owned subsidiary of BMS

UNKNOWN

lead

Marcelo Pasquini, MD

OTHER

NCT05032820 - Upfront Chimeric Antigen Receptor T-Cell to Upgrade Response in Multiple Myeloma | Biotech Hunter | Biotech Hunter