Sub-study of Belantamab Mafodotin (GSK2857916) in Combination With Isatuximab in Participants With RRMM
NCT07217184 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2025-10-15
Summary
The primary purpose is to determine the safety and tolerability of belantamab mafodotin in combination with isatuximab, and to establish the recommended Phase 2 dose (RP2D) for the combination treatment to explore in the cohort expansion (CE) phase in participants with RRMM. This study is a sub study of the Master protocol (NCT04126200).
Conditions
Interventions
- DRUG
-
Belantamab mafodotin will be administered.
- DRUG
-
Isatuximab
Isatuximab will be administered.
Sponsors & Collaborators
- lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-07-29
- Primary Completion
- 2025-04-17
- Completion
- 2027-03-11
- FDA Drug
- Yes
Countries
- United States
- Australia
- Brazil
- Canada
- France
- Greece
- Mexico
- Norway
- South Korea
- Spain
- Sweden
Study Locations
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