At a glance
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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
In Brief
A Phase 2 clinical trial evaluating Lenalidomide, bb2121, and 3 other interventions for Multiple Myeloma. Completed, enrolled 40 participants across 15 sites.
Detailed 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).
Study Details
Timeline
Interventions
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
Participants receive infusion of BCMA CAR T-cells at a target dose of 450 x 10\^6 cells.
300 mg/m\^2/day for 3 consecutive days prior to the CAR T infusion
30 mg/m\^2/day or 3 consecutive days prior to the CAR T infusion
Placement of central line catheter and leukapheresis