NCT05583617

A Study Evaluating the Safety and Efficacy of Multiple Treatments in Participants With Multiple Myeloma

A Platform Study Evaluating the Safety and Efficacy of Multiple Treatments in Patients With Multiple Myeloma

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Cevos + Len substudy(SS) 2 (DIRAC): This substudy will explore the combination of cevostamab and lenalidomide as post-transplant maintenance therapy in participants with MM with high-risk cytogenetic features who experienced at least a partial response (PR) after induction. Cevostamab + Iberdomide SS4 (CHAWLA): This substudy will evaluate the safety, tolerability, PK, and pharmacodynamics of the combination of cevostamab and iberdomide in participants with R/R MM who have received at least three prior lines of therapy, including a PI, an IMiD, and an anti-CD38 monoclonal antibody.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
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	Lenalidomide will be administered PO on days 1-21 of a 28-day cycle.
DRUG	Tocilizumab	Tocilizumab will be administered for the treatment of cytokine release syndrome (CRS) when necessary.
DRUG	Iberdomide	Iberdomide will be administered PO on days 1-14 of a 21-day cycle.
DRUG	Dexamethasone	Dexamethasone will be administered on Days 2 and 8 of Cycles 1-3.

Timeline

• Start date: 2023-11-14
• Primary completion: 2028-07-31
• Completion: 2028-07-31
• First posted: 2022-10-18
• Last updated: 2026-04-03

Locations

16 sites across 6 countries: Australia, France, Germany, Poland, South Korea, Spain

Regulatory

• FDA-regulated drug study