CO46096 CEVOSTAMAB IN PATIENTS WITH MULTIPLE MYELOMA
Research type
Research Study
Full title
A PHASE III, RANDOMIZED, OPEN-LABEL, MULTICENTER STUDY EVALUATING THE EFFICACY AND SAFETY OF CEVOSTAMAB IN COMBINATION WITH POMALIDOMIDE AND DEXAMETHASONE VERSUS STANDARD OF CARE IN PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED ONE TO THREE PRIOR LINES OF THERAPY
IRAS ID
1013612
Contact name
N/A N/A
Contact email
Sponsor organisation
F. Hoffmann-La Roche AG
Eudract number
2025-524028-23
Research summary
Multiple myeloma is a type of cancer that affects plasma cells in the bone marrow, primarily impacting the body’s ability to fight infection as cancerous cells multiply and displace healthy blood cells. Relapsed/refractory multiple myeloma (R/R MM) represents a significant clinical challenge, as the disease eventually returns or stops responding to treatment in the majority of patients.
Current standard-of-care therapies vary depending on the specific type of MM, yet there remains a critical need for treatments that provide better long-term health outcomes for those whose cancer has returned. Cevostamab is an experimental immunotherapy designed to engage the patient’s own immune system to target and destroy cancer cells. By utilising a mechanism that helps the immune system recognise the cancer, researchers hope to overcome the resistance seen with existing treatments.
Given the relapsing nature of this condition and the necessity for more effective options after initial therapies, further research is required to establish more durable responses. This study follows previous research into cevostamab and aims to determine if its use in combination with other agents can improve the depth and duration of response in patients who have already received multiple lines of therapy.
This study will evaluate the efficacy, safety, and pharmacokinetics of cevostamab in combination with pomalidomide and dexamethasone compared with standard-of-care therapy (daratumumab, elotuzumab, or carfilzomib) in patients with multiple myeloma who have received one to three prior lines of therapy. The primary focus is to assess the number of participants who show no evidence of cancer on tests or scans after nine months of treatment.
Approximately 380 patients will be recruited globally, with approximately 15 patients recruited at 5 UK sites. The total time of participation for an individual is expected to range from 1 day to more than 3 years from screening to the final follow-up visit.REC name
South Central - Hampshire A Research Ethics Committee
REC reference
26/SC/0082
Date of REC Opinion
8 May 2026
REC opinion
Further Information Favourable Opinion