GO42552 (CAMMA1) – Cevostamab in Relapsed/Refractory Multiple Myeloma
Research type
Research Study
Full title
AN OPEN-LABEL, MULTICENTER, PHASE Ib TRIAL EVALUATING THE SAFETY, PHARMACOKINETICS, AND ACTIVITY OF CEVOSTAMAB IN PATIENTS WITH RELAPSED OR REFACTORY MULTIPLE MYELOMA (CAMMA 1)
IRAS ID
1004618
Contact name
Rachel Tedds
Contact email
Sponsor organisation
Genentech, Inc
Eudract number
2021-000238-33
ISRCTN Number
ISRCTN53331091
Clinicaltrials.gov Identifier
Research summary
Multiple myeloma (MM) is a malignant disease that remains incurable despite advances in treatment, with an average survival of 8-10 years and 2-3 years for high-risk disease. Increased survival has been achieved with the introduction of new treatments.
Nevertheless, despite this clear progress, most patients eventually relapse, and the outcome of patients after they become refractory, or ineligible to receive further treatment, is quite poor, with survival of approx 1 year. Therefore, relapsed or refractory (R/R) MM continues to be a significant unmet medical need, and novel therapeutic agents are still necessary.
This study is testing a drug called cevostamab given by itself, or in combination with pomalidomide plus dexamethasone, or with daratumumab plus dexamethasone.
Initial clinical data indicates that cevostamab monotherapy is of benefit to heavily pretreated patients with R/R MM. Combination with additional myeloma agents offers the potential to further improve outcome.
The purpose of this study is to test cevostamab administered using a different dosing schedule than studied in previous clinical trials and cevostamab in combination with pomalidomide plus dexamethasone and with daratumumab plus dexamethasone to find out if they are safe and to understand the way the body processes the drugs.
Cevostamab is an experimental drug, which means health authorities have not approved cevostamab for the treatment of MM. Pomalidomide, daratumumab, and dexamethasone are all approved for use in MM.
Total time in the study will depend on how the individual tolerates study treatment as well as how their MM responds to the treatment. This could range from 1 day to 12 months or longer.
There will be approximately 6 patients recruited at 2 UK sites. 120 patients in total will be recruited worldwide.The study is sponsored by Genentech Inc.
REC name
London - London Bridge Research Ethics Committee
REC reference
22/LO/0225
Date of REC Opinion
3 May 2022
REC opinion
Further Information Favourable Opinion