Clinical trial · Interventional
MagnetisMM-4: Umbrella Study of Elranatamab (PF-06863135) in Combination With Anti-Cancer Treatments in Multiple Myeloma
A PHASE 1B/2, OPEN LABEL UMBRELLA STUDY OF ELRANATAMAB (PF-06863135), A B-CELL MATURATION ANTIGEN (BCMA) CD3 BISPECIFIC ANTIBODY, IN COMBINATION WITH OTHER ANTI-CANCER TREATMENTS IN PARTICIPANTS WITH MULTIPLE MYELOMA
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): A business decision was made by Pfizer to terminate the study and not proceed with the Phase 2 expansion of this study. The reason for study termination is not due to any safety concerns or requests from regulatory authorities.
Summary
Brief summary (as posted)
The purpose of this study is to determine the Recommended Phase 2 Dose and clinical benefit of elranatamab in combination with other anti-cancer therapies in participants with multiple myeloma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Elranatamab + lenalidomide + dexamethasone | Drug | — | UNRESOLVED |
| Elranatamab + Nirogacestat | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Sub-Study A
- description
- BCMA-CD3 bispecific antibody + gamma secretase inhibitor
- interventionNames
- Drug: Elranatamab + Nirogacestat
- type
- EXPERIMENTAL
- label
- Sub-Study B
- description
- BCMA-CD3 bispecific antibody + immunomodulatory drug
- interventionNames
- Drug: Elranatamab + lenalidomide + dexamethasone
Primary outcomes (2)
- measure
- SSA: Number of Participants With Dose Limiting Toxicities (DLTs)- Phase 1b Dose Escalation
- timeFrame
- From Cycle 0 Day 1 through Cycle 1 Day 28 (approximately up to 35 days)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Relapsed/refractory multiple myeloma with at least 3 prior lines of therapy * Refractory to at least one IMiD, one proteasome inhibitor, and one anti-CD38 antibody * Measurable disease defined by at least one of the following: 1. Serum M-protein \>/= 0.5 g/dL by SPEP 2. Urinary M-protein excretion \>/= 200 mg/24 hours by UPEP 3. Serum immunoglobulin FLC \>/= 10 mg/dL (\>/= 100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FLC ratio * ECOG performance status 0 -1 * Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade \</= 1 Exclusion Criteria: * Active plasma cell leukemia * Amyloidosis * Stem cell transplant with 12 weeks prior to enrollment, or active GVHD * POEMS syndrome * Any active uncontrolled bacterial, fungal, or viral infection * Impaired cardiovascular function or clinically significant cardiovascular diseases within 6 months prior to enrollment * Previous administration with an investigational drug within 30 days or 5 half-lives preceding the first dose of study treatment (whichever is longer) * Sub-Study A Only: Previous treatment with BCMA bispecific antibody * Sub-Study B Only: Previous treatment with BCMA directed therapy
References
Publications (0)
Data not yet available