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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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-505183-10-00
Acronym
bb2121-MM-002
Enrollment
20
Registered
2024-02-12
Start date
2019-01-04
Completion date
2025-10-14
Last updated
2025-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Relapsed and refractory multiple myeloma (RRMM), multiple myeloma (MM) with progression within 18 months of initial treatment/ or newly diagnosed multiple myeloma (NDMM) with suboptimal response post autologous stem cell transplant (ASCT) (Cohort 3 only)

Brief summary

Overall response rate (ORR) (Cohort 1), Complete response (CR) rate Cohort 1b,Cohort2a,Cohort 2b,Cohort 2c,and Cohort 3

Detailed description

Complete response (CR) rate (Cohort 1), Overall response rate (ORR) Cohort 1b, 2a, b,cand 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), Pharmacokinetics, Immunogenicity, Health-related Quality of Life (HRQoL), Feasibility of lenalidomide maintenance therapy post-bb2121 infusion (Cohort 3)

Interventions

Sponsors

Celgene Corp.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Overall response rate (ORR) (Cohort 1), Complete response (CR) rate Cohort 1b,Cohort2a,Cohort 2b,Cohort 2c,and Cohort 3

Secondary

MeasureTime frame
Complete response (CR) rate (Cohort 1), Overall response rate (ORR) Cohort 1b, 2a, b,cand 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), Pharmacokinetics, Immunogenicity, Health-related Quality of Life (HRQoL), Feasibility of lenalidomide maintenance therapy post-bb2121 infusion (Cohort 3)

Countries

France, Germany, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026