C1071030 - Phase 1b Study of Relapsed Refractory Multiple Myeloma
Research type
Research Study
Full title
A PHASE 1B, OPEN-LABEL STUDY OF ELRANATAMAB IN COMBINATION WITH IBERDOMIDE IN PARTICIPANTS WITH RELAPSED REFRACTORY MULTIPLE MYELOMA
IRAS ID
1008050
Contact name
Cynthia Green
Contact email
Sponsor organisation
Pfizer Inc.
ISRCTN Number
N/A
Clinicaltrials.gov Identifier
Pending
Research summary
The purpose of this study is to evaluate how safe and tolerable elranatamab is when given in combination with iberdomide. People with multiple myeloma who have received previous treatment with lenalidomide or pomalidomide, and with a proteasome inhibitor will be enrolled in the study. There are 2 parts to this study. Part 1 (Dose Escalation) will assess the safety and tolerance of elranatamab in combination with iberdomide in participants with relapsed/refractory multiple myeloma to select two doses for further evaluation in Part 2. Part 2 (Randomized Dose Optimization) will further evaluate the safety of this combination by randomizing participants to receive elranatamab with iberdomide at either a higher or a lower dose. No placebo is used in this study. Both parts of the study will look at the amount of each study drug in the blood and how it is changed and removed from the body (pharmacokinetics). Participants in both parts of the study will receive study treatment until their disease progresses, they experience unacceptable side effects, or they choose to no longer participate in the study. Both parts of this study will take place in North America and the UK.
REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
23/YH/0258
Date of REC Opinion
28 Dec 2023
REC opinion
Further Information Unfavourable Opinion