CA057-1040 Phase 1b/2a Open-Label Dose Escalation/ Optimisation of Mezigdomide & Elranatamab in RRMM
Research type
Research Study
Full title
A Phase 1b/2a, Multicenter, Open-label Study to Determine the Recommended Dose and Schedule, and Evaluate the Safety and Preliminary Efficacy of Mezigdomide in Combination with Elranatamab in Participants with Relapsed and/or Refractory Multiple Myeloma
IRAS ID
1011267
Contact name
GSM-CT Representative
Contact email
Sponsor organisation
Celgene Corp.
Eudract number
2025-522090-11
Clinicaltrials.gov Identifier
Research summary
This study is testing a new drug called Mezigdomide in adults with a type of blood cancer called Multiple Myeloma that has come back or is hard to treat. These adults have already tried other treatments for their cancer. The study will check how well Mezigdomide works and how safe it is when given with another drug called Elranatamab.
Elranatamab is already approved for the treatment of Multiple Myeloma (MM.) It is g given intravenously (into the vein) and stimulates the destruction of Multiple Myeloma cells. Dexamethasone is an approved corticosteroid drug often use to treat MM.
Mezigdomide is an oral medicine that may help other medicines such as Elranatamab work better.
The study will take place in various locations around the world. Participants will go through different stages: screening (up to 28 days), treatment (up to 5 years) and follow-up stages as required. This study will have two groups - participants taking part in Phase 1 will test different doses of Mezigdomide with a fixed dose of Elranatamab to find the best dose combination and see if the drugs have the potential to help patients with RRMM. In Phase 2, participants will be randomly assigned to one of the two tolerated doses found in Phase 1.
Participants in Phase 1 must be over 18 with a history of RRMM that has been treated with 2 to 4 prior lines of anti-myeloma therapy. Participants in Phase 2 must be over 18 with a history of RRMM that has been treated with 1 to 3 prior lines of anti-myeloma therapy.
Approximately 62 participants will take part in the study worldwide, with 7 participants taking part in the UK. Approximately 18 in Phase 1 and approximately 44 participants in Phase 2.REC name
East of England - Cambridge South Research Ethics Committee
REC reference
25/EE/0227
Date of REC Opinion
5 Dec 2025
REC opinion
Further Information Favourable Opinion