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Protocol # 18-604




This study is a multi-cohort, open-label, multicenter Phase 2 study to evaluate the efficacy and safety of bb2121 in subjects with relapsed and refractory MM (Cohort 1), in subjects with MM having progressed within 18 months of initial treatment including autologous stem cell transplantation (ASCT) (Cohort 2a), or without ASCT (Cohort 2b) or, in subjects with inadequate response post ASCT during initial treatment (Cohort 2c). Approximately 235 subjects will be enrolled into one of three cohorts. Cohort 1 will enroll approximately 97 RRMM subjects with ≥ 3 prior anti-myeloma treatment regimens. Cohort 2a will enroll approximately 39 MM subjects, with 1 prior anti-myeloma therapy including ASCT and with early relapse. Cohort 2b will enroll approximately 39 MM subjects with 1 prior anti-myeloma therapy not including ASCT and with early relapse. Cohort 2c will enroll approximately 30 MM subjects with inadequate response to ASCT during their initial anti-myeloma therapy. The cohorts will start in parallel and independently. Cohort 3 will enroll approximately 30 newly diagnosed multiple myeloma (NDMM) participants with suboptimal response to ASCT.


  • Multiple Myeloma


  • bb2121
  • Lenalomide


Phase 2

Study Type


Further Study Details

Primary Outcome:

  • Overall response rate (ORR)- Cohort 1
  • Complete response (CR) rate - Cohort 2a , b, c and Cohort 3

Secondary Outcome:

  • Complete response (CR) rate - Cohort 1
  • Overall response rate (ORR) - Cohort 2a, b, c and Cohort 3
  • Very good partial response (VGPR) rate - Cohort 2c
  • Time to response (TTR)
  • Duration of response (DoR)
  • Progression-free survival (PFS)
  • Time to progression (TTP)
  • Overall survival (OS)
  • Adverse Events (AEs)
  • Percentage of participants who received lenalidomide maintenance for the first 3 cycles following bb2121 infusion with at least 75% dose compliance - Cohort 3
  • Pharmacokinetics - Cmax
  • Pharmacokinetics - tmax
  • Pharmacokinetics - AUC
  • Pharmacokinetics - tlast
  • Pharmacokinetics - AUC0-28days
  • Immunogenicity
  • 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



Study Start Date

December 13, 2018


  • Gender:     All
  • Minimum age:     18 Years
  • Maximum age:     N/A
  • Healthy volunteers:     No





Official title

A Phase 2, Multi-cohort, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of bb2121 in Subjects With Relapsed and Refractory Multiple Myeloma and in Subjects With Clinical High-Risk Multiple Myeloma (KarMMa-2) Identifier



Source: Through our founding membership in the Dana-Farber/Harvard Cancer Center, an NCI-designated Comprehensive Cancer Center, these clinical trials are conducted at the Massachusetts General Hospital Cancer Center and may be available at other partner institutions.