A Study Evaluating the Safety and Efficacy of Multiple Treatments in Participants With Multiple Myeloma
NCT05583617 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 200
Last updated 2026-05-04
Summary
CO43923 is a platform study that will evaluate the safety, efficacy, and pharmacokinetics (PK) of multiple treatment combinations, as monotherapy or in combination, in participants with multiple myeloma (MM). The study is designed with the flexibility to open new treatment substudies as new treatments become available. Information regarding the opened substudies are found below.
Conditions
Interventions
- DRUG
-
Cevostamab
Substudy 2: Cevostamab will be administered intravenously (IV) on a 28-day cycle, up to a total of 13 cycles. Substudy 4: Cevostamab will be administered by IV on a 21-day cycle, up to a total of 17 cycles.
- DRUG
-
Lenalidomide will be administered PO on days 1-21 of a 28-day cycle.
- DRUG
-
Tocilizumab will be administered for the treatment of cytokine release syndrome (CRS) when necessary.
- DRUG
-
Iberdomide will be administered PO on days 1-14 of a 21-day cycle.
- DRUG
-
Dexamethasone will be administered on Days 2 and 8 of Cycles 1-3.
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Clinical Trials · Hoffmann-La Roche
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-11-14
- Primary Completion
- 2028-07-31
- Completion
- 2028-07-31
- FDA Drug
- Yes
Countries
- Australia
- France
- Germany
- Poland
- South Korea
- Spain
Study Locations
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