CO43476 CAMMA 2; Study to evaluate cevostamab in multiple myeloma
Research type
Research Study
Full title
A PHASE I/II, OPEN-LABEL, MULTI-COHORT STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CEVOSTAMAB IN PRIOR B CELLMATURATION ANTIGEN-EXPOSED PATIENTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA
IRAS ID
1008283
Contact name
Rachel Tedds
Contact email
Sponsor organisation
F. Hoffman-La Roche Ltd.
Eudract number
2021-006816-10
Research summary
Despite advances in therapy, multiple myeloma remains an incurable disease, and most patients eventually do not respond well to currently available treatments (refractory MM). Only 10%-15% of patients achieve or exceed expected survival compared with the matched general population. Therefore, there is an unmet need for novel treatments for patients with multiple relapses or refractory disease.
The purpose of this study is to measure the effects, good or bad, of cevostamab on participants with multiple myeloma that has worsened or has not responded to treatment. Cevostamab will be administered by intravenous infusion once every 21-days called a cycle, except during the first cycle where multiple doses of cevostamab will be administered in increasing doses until the target dose is reached. Treatment will continue until the participant’s multiple myeloma worsens, they are unable to tolerate cevostamab due to side effects, or they have a new or worsening medical condition that may impact the participant safety. The total time in the study could range from 1 day to more than 48 months.
Approximately 120-140 participants will be enrolled in this study.
The study is sponsored by F. Hoffmann- La Roche
Research Summary; v2 dated 09Sep2023
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
23/NE/0161
Date of REC Opinion
24 Sep 2023
REC opinion
Further Information Favourable Opinion