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


Active: Yes
Cancer Type: Multiple Myeloma
Plasma cell neoplasm
NCT ID: NCT03601078
Trial Phases: Phase II Protocol IDs: BB2121-MM-002 (primary)
NCI-2018-01730
U1111-1216-4209
2018-000264-28
Eligibility: 18 Years and older, Male and Female Study Type: Treatment
Study Sponsor: Celgene
NCI Full Details: http://clinicaltrials.gov/show/NCT03601078

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 264
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.

Objectives

Anti-myeloma bridging treatment is allowed for disease control while bb2121 is being
manufactured for cohorts 1, 2a and 2b only.

Treatment Sites in Georgia

Emory University School of Medicine
1440 Clifton Road
Atlanta, GA 30322


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