CompletedPhase 2

An Efficacy and Safety Study of bb2121 in Subjects With Relapsed and Refractory Multiple Myeloma and in Subjects With High-Risk Multiple Myeloma

United States312 participantsStarted 2018-12-13

Plain-language summary

This study is a multi-cohort, open-label, multicenter Phase 2 study to evaluate the efficacy and safety of bb2121 in participants with relapsed and refractory multiple myeloma (RRMM) (Cohort 1), in participants with RRMM who receive bridging therapy with talquetamab (Cohort 1b), in participants with multiple myeloma (MM) having progressed within 18 months of initial treatment with autologous stem cell transplantation (ASCT) (Cohort 2a) and without ASCT (Cohort 2b) or, in participants with inadequate response post ASCT during initial treatment (Cohort 2c) and the efficacy and safety of bb2121 used in combination with lenalidomide maintenance in participants with suboptimal response post ASCT (Cohort 3). Approximately 248 participants will be enrolled into one of three cohorts. Cohort 1 (including cohort 1b) will enroll approximately 126 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Subject is ≥ 18 years of age at the time of signing the informed consent form (ICF)
✓. For Cohorts 1 and 2 only, participant has measurable disease, defined as:
✓. Subjects with one of the following cohort specific requirements:
✓. Subject must have Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
✓. Subject must have recovery to Grade 1 or baseline of any non-hematologic toxicities due to prior treatments, excluding alopecia and Grade 2 neuropathy

Exclusion criteria

✕. Subject used any investigational agents within 14 days prior to leukapheresis or, for Cohort 3, within 14 days prior to consent
✕. Subject received any of the following within the last 14 days prior to leukapheresis or, for Cohort 3, within 14 days prior to consent:
✕. Plasmapheresis
✕. Major surgery (as defined by the investigator)

What they're measuring

Overall response rate (ORR)- Cohort 1

Timeframe: Up to approximately 5 years (Participants will transition to the long term follow-up (LTFU) study after a minimum of 12 months post-infusion for Cohorts 1, 2a, 2b, and 2c; and after a minimum of 6 months post-infusion for Cohort 1b, at their next visit)

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

Timeframe: Up to approximately 5 years (Participants will transition to the LTFU study after a minimum of 12 months post-infusion for Cohorts 1, 2a, 2b, and 2c; and after a minimum of 6 months post-infusion for Cohort 1b, at their next visit)

Trial details

NCT IDNCT03601078

SponsorCelgene

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-01-15

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