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A Phase 2, Multicohort, Open-label, Multicenter Study to Determine the Efficacy and Safety of bb2121 in Subjects With Relapsed and Refractory Multiple Myeloma and in Subjects With High-Risk Multiple Myeloma Having Progressed Within One Year of Initial Treatment (KarMMa-2)

Status
Active
Cancer Type
Lymphoma
Multiple Myeloma
Trial Phase
Phase II
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT03601078
Protocol IDs
BB2121-MM-002 (primary)
NCI-2018-01730
U1111-1216-4209
2018-000264-28
Study Sponsor
Celgene

Summary

This study is a multi-cohort, open-label, multicenter Phase 2 study to determine the efficacy and safety of bb2121 in subjects with relapsed and refractory MM (Cohort 1) and in subjects with HR MM having progressed within one year of initial treatment (Cohort 2). Approximately 122 subjects will be enrolled into one of two cohorts. Cohort 1 will enroll approximately 73 RRMM subjects with = 3 prior anti-myeloma treatment regimens. Cohort 2 will enroll approximately 49 MM subjects with 1 prior anti-myeloma treatment regimen and HR disease defined as Stage III by the Revised International Staging System (R-ISS) and early relapse. The cohorts will start in parallel and independently.

Objectives

Anti-myeloma bridging treatment is allowed for disease control while bb2121 is being manufactured.

Treatment Sites in Georgia

Emory University School of Medicine


1440 Clifton Road
Atlanta, GA 30322


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