At a glance
ClinicalIndex Comparison Record- ✓Prior diagnosis of multiple myeloma as defined by IMWG criteria
- ✓Measurable disease: serum M-protein ≥0.5 g/dL, OR urinary M-protein ≥200 mg/24h, OR serum FLC ≥10 mg/dL with abnormal kappa/lambda ratio
- ✓Prior anti-myeloma therapy including lenalidomide
- ✓Resolved acute effects of prior therapy to baseline or Grade ≤1
- ✕Smoldering multiple myeloma
- ✕Plasma cell leukemia
- ✕Amyloidosis
- ✕POEMS Syndrome
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
NCT05020236Phase 3RecruitingMonitorCompletion was 2mo agoAN OPEN-LABEL, 3-ARM, MULTICENTER, RANDOMIZED PHASE 3 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ELRANATAMAB (PF-06863135) MONOTHERAPY AND ELRANATAMAB + DARATUMUMAB VERSUS DARATUMUMAB + POMALIDOMIDE + DEXAMETHASONE IN PARTICIPANTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST 1 PRIOR LINE OF THERAPY INCLUDING LENALIDOMIDE AND A PROTEASOME INHIBITOR
In Brief
A Phase 3 clinical trial evaluating Elranatamab, Daratumumab, and 2 other interventions for Multiple Myeloma. Currently recruiting, targeting 944 participants across 90 sites in 22 countries.
Signals
Detailed Summary
The purpose of this clinical trial is to (1) learn whether the BCMA-CD3 bispecific antibody elranatamab can provide more benefit to people with multiple myeloma compared to a combination therapy including daratumumab, pomalidomide, and dexamethasone, and (2) learn about the safety and activity of elranatamab in combination with the anti-CD38 monoclonal antibody daratumumab. People with multiple myeloma who have received previous treatment including lenalidomide will be enrolled in the study. Part 1 of the study will assess the safety and activity of different doses of elranatamab in combination with daratumumab. People participating in Part 2 of the study will be randomly assigned to receive either elranatamab alone, elranatamab plus daratumumab, or daratumumab, pomalidomide, and dexamethasone. Part 2 will evaluate the safety and activity of (1) elranatamab alone compared to daratumumab, pomalidomide, and dexamethasone, and (2) elranatamab plus daratumumab. Part 3 will assess the effect of increased measures to protect against infection in people treated with either elranatamab alone or together with daratumumab. All people participating in 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.
Study Details
Timeline
Interventions
subcutaneous
Daratumumab / hyaluronidase, subcutaneous
oral
oral