BB2121-MM-003 (KarMMa-3) (R/R)

A phase 3, Multicenter, Randomized, Open-label Study to Compare the Efficacy and Safety of bb2121 Versus Standard Triplet Regimens in Subjects With Relapsed and Refractory Multiple Myeloma (RRMM) (KarMMa-3)

Study treatment

• Experimental arm: bb2121 autologous CAR T cells will be infused at a dose ranging from 150 - 450 x 10^6 CAR+ T cells after receiving lymphodepleting chemotherapy
• Standard arm: Daratumumab+pomalidomide+dexa or daratumumab+bortezomib+dexa or ixazomib+lenalidomide+dexa

Inclusion criteria

• ≥ 18 years of age
• Documented diagnosis of Multiple myeloma and measurable disease
• has received at least 2 but no greater than 4 prior MM regimens
• has received prior treatment with DARA, a proteasome inhibitor- and an immunomodulatory compound-containing regimen for at least 2 consecutive cycles
• refractory to the last treatment regimen
• achieved a response (minimal response or better) to at least 1 prior treatment regimen
• ECOG 0-1

Exclusion criteria

• nonsecretory multiple myeloma
• inadequate pulmonary function
• active or history of plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome or amyloidosis
• known central nervous system (CNS) involvement with myeloma
• history of an allogeneic hematopoietic stem cell transplantation
• has received autologous stem cell transplantation (ASCT) within 12 weeks prior to randomization

Participating sites

• University Hospital Leuven Gasthuisberg