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

Official Title

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

Summary:

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
  • Biomarker - Cytokines
  • Biomarker - BCMA
  • 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.

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society