Clinical trial · Interventional
PF-06863135 As Single Agent And In Combination With Immunomodulatory Agents In Relapse/Refractory Multiple Myeloma
MAGNETISMM-1 A PHASE I, OPEN LABEL STUDY TO EVALUATE THE SAFETY, PHARMACOKINETIC, PHARMACODYNAMIC AND CLINICAL ACTIVITY OF ELRANATAMAB (PF-06863135), A B-CELL MATURATION ANTIGEN (BCMA) - CD3 BISPECIFIC ANTIBODY, AS A SINGLE AGENT AND IN COMBINATION WITH IMMUNOMODULATORY AGENTS IN PATIENTS WITH RELAPSED/REFRACTORY ADVANCED MULTIPLE MYELOMA (MM)
NCT03269136CI-TRIAL-00087318completedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To assess the safety and tolerability at increasing dose levels of PF-06863135 in patients with relapse/ refractory multiple myeloma in order to determine the maximum tolerated dose and select the recommended Phase 2 dose.
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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PF-06863135 + dexamethasone | Drug | — | UNRESOLVED |
| PF-06863135 + lenalidomide | Drug | — | UNRESOLVED |
| PF-06863135 monotherapy IV or SC | Drug | — | UNRESOLVED |
| PF-06863135 + pomalidomide | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- PF-06863135
- description
- BCMA-CD3 bispecific antibody
- interventionNames
- Drug: PF-06863135 monotherapy IV or SC
- type
- EXPERIMENTAL
- label
- PF-06863135 + dexamethasone
- description
- BCMA-CD3 bispecific antibody + dexamethasone
- interventionNames
- Drug: PF-06863135 + dexamethasone
- type
- EXPERIMENTAL
- label
- PF-06863135 + lenalidomide
- description
- BCMA-CD3 bispecific antibody + lenalidomide
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Relapsed/refractory multiple myeloma * Progressed or are intolerant of established therapies including proteasome inhibitor, immunomodulatory drug, and anti-CD38 antibody * Performance Status of 0- 1 ( Performance Score 2 is permitted only if due to underlying myeloma) * Adequate bone marrow, hematological, kidney and liver function * Resolved acute effects of any prior therapy to baseline severity * Not pregnant Exclusion Criteria: * Recent history of other malignancies * History of active autoimmune disorders * Any form of primary immunodeficiency * Active and clinically significant bacterial, fungal, or viral infection * Evidence of active mucosal or internal bleeding * History of severe immune-mediated adverse event with prior immunomodulatory treatment * Major surgery within 4 weeks of study treatment start * Radiation therapy within 2 weeks of study treatment start * History of stem cell transplant (autologous or allogeneic) within 100 days prior to study enrollment * Donor Lymphocyte Infusion (DLI) within 30 days prior to study entry * Less than 30 days since last dose of antibody based therapies or less than 5 half-lives since last dose of previous therapy * Requirement for systemic immune suppressive medication except as permitted in the protocol * Current requirement for chronic blood product support
References
Publications (4)
- DERIVEDHibma JE, Irby D, Liu A, Elmeliegy M, King LE, Gifondorwa D, Jiang S, Poels KE, Soltantabar P, Lon HK, Shtylla B, Wang D, Williams JH, Nicholas T. Elranatamab Population Pharmacokinetics and Exposure-Response for Cytokine Release Syndrome in Patients with Relapsed or Refractory Multiple Myeloma. Clin Pharmacokinet. 2026 Aug;65(8):1173-1192. doi: 10.1007/s40262-026-01663-z. Epub 2026 Jun 13. PMID 42287565
- DERIVEDLon HK, Hibma J, Jiang S, Sullivan S, Vandendries E, Skoura A, Wang D, Elmeliegy M. Population Exposure-Response Efficacy Analysis of Elranatamab (PF-06863135) in Patients with Multiple Myeloma. Target Oncol. 2025 Sep;20(5):803-819. doi: 10.1007/s11523-025-01168-y. Epub 2025 Aug 18. PMID 40826257
- DERIVEDElmeliegy M, Viqueira A, Vandendries E, Hickman A, Conte U, Irby D, Hibma J, Lon HK, Piscitelli J, Soltantabar P, Skoura A, Jiang S, Wang D. Dose Optimization of Elranatamab to Mitigate the Risk of Cytokine Release Syndrome in Patients with Multiple Myeloma. Target Oncol. 2025 Mar;20(2):349-359. doi: 10.1007/s11523-025-01134-8. Epub 2025 Feb 25. PMID 40000533
- DERIVEDBahlis NJ, Costello CL, Raje NS, Levy MY, Dholaria B, Solh M, Tomasson MH, Damore MA, Jiang S, Basu C, Skoura A, Chan EM, Trudel S, Jakubowiak A, Gasparetto C, Chu MP, Dalovisio A, Sebag M, Lesokhin AM. Elranatamab in relapsed or refractory multiple myeloma: the MagnetisMM-1 phase 1 trial. Nat Med. 2023 Oct;29(10):2570-2576. doi: 10.1038/s41591-023-02589-w. Epub 2023 Oct 2. PMID 37783970