Efficacy and Safety Study of bb2121 in Subjects With Relapsed and Refractory Multiple Myeloma

Official Title

A Phase 2, Multicentre Study to Determine the Efficacy and Safety of bb2121 in Subjects With Relapsed and Refractory Multiple Myeloma


This is an open label, single-arm, multicentre, Phase 2 study to evaluate the efficacy and safety of bb2121 in subjects with relapsed and refractory multiple myeloma. A leukapheresis procedure will be performed to manufacture bb2121 chimeric antigen receptor (CAR) modified T cells. Prior to bb2121 infusion subjects will receive lymphodepleting therapy with fludarabine and cyclophosphamide.

Trial Description

Primary Outcome:

  • Overall Response Rate (ORR)
Secondary Outcome:
  • Complete Response (CR) Rate
  • Time to Response
  • Duration of Response
  • Progression-free Survival (PFS)
  • Time to Progression (TTP)
  • Overall Survival (OS)
  • Adverse Events (AEs)
  • Pharmacokinetics - Cmax
  • Pharmacokinetics - Tmax
  • Pharmacokinetics - AUC
  • Immunogenicity
  • Minimal Residual Disease (MRD)
  • Subject-reported outcomes as measured by European Organization for Research and Treatment of Cancer Quality-of-Life questionnaire (EORTC-QLQ-C30)
  • Subject-reported outcomes as measured by EuroQoL Group EQ-5D-5L Health Questionnaire
  • Subject-reported outcomes as measured by EORTC-QLQ-MY20
Anti-myeloma bridging treatment is allowed for disease control while bb2121 is being manufactured. Three sites in Japan will be activated in 2019 and will be open for enrollment to patients in Japan.

View this trial on ClinicalTrials.gov

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Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society