drugset / Trial / NCT03269136
PF-06863135 As Single Agent And In Combination With Immunomodulatory Agents In Relapse/Refractory Multiple Myeloma
Non-randomizedSequentialOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2017-11-29
- Primary completion
- 2024-01-19
- Completion
- 2024-01-19
Outcome
Met primary endpoint
paper Primary endpoints, including the incidence of dose-limiting toxicities as well as objective response rate (ORR) and duration of response (DOR), were met. PMID 37783970 ↗
Publications
- Hibma 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 Jun 13. doi: 10.1007/s40262-026-01663-z. Online ahead of print.
- Lon 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.
- Elmeliegy 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.
- Bahlis 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dexamethasone | Small molecule | — | Oral |
| Subject | Elranatamab | Monoclonal antibody | — | Intravenous |
| Subject | Lenalidomide | Other / unclassified | — | Oral |
| Subject | Pomalidomide | Other / unclassified | — | Oral |