drugset / Trial / NCT03110822
A Phase 1 Study of Ruxolitinib, Steroids and Lenalidomide for Relapsed/Refractory Multiple Myeloma (RRMM) Patients
Non-randomizedSequentialOpen-labelTreatment
Summary
This is a phase 1, multicenter, open-label study evaluating the safety and efficacy of ruxolitinib, steroids and lenalidomide among MM patients who currently show progressive disease.
Timeline
- Start
- 2017-02-01
- Primary completion
- 2024-09
- Completion
- 2027-02
Publications
- Berenson JR, Limon A, Rice S, Safaie T, Boccia R, Yang H, Moezi M, Lim S, Schwartz G, Eshaghian S, Brobeck M, Swift R, Eades BM, Bujarski S, Sebhat Y, Ray R, Kim S, Del Dosso A, Vescio R. A Phase I Trial Evaluating the Addition of Lenalidomide to Patients with Relapsed/Refractory Multiple Myeloma Progressing on Ruxolitinib and Methylprednisolone. Target Oncol. 2024 May;19(3):343-357. doi: 10.1007/s11523-024-01049-w. Epub 2024 Apr 20.
- Berenson JR, Martinez D, Safaie T, Boccia R, Yang H, Moezi M, Lim S, Schwartz G, Eshaghian S, Swift R, Eades BM, Bujarski S, Regidor B, Kim C, Kim S, Vescio R. Ruxolitinib and methylprednisolone for treatment of patients with relapsed/refractory multiple myeloma. Br J Haematol. 2023 Mar;200(6):722-730. doi: 10.1111/bjh.18593. Epub 2022 Dec 9.
- Berenson JR, Kim C, Bujarski S, To J, Spektor TM, Martinez D, Turner C, Ghermezi M, Eades BM, Swift RA, Schwartz G, Eshaghian S, Moss RA, Lim S, Vescio R. A phase 1 study of ruxolitinib, steroids and lenalidomide for relapsed/refractory multiple myeloma patients. Hematol Oncol. 2022 Dec;40(5):906-913. doi: 10.1002/hon.3066. Epub 2022 Aug 14.
- Berenson JR, To J, Spektor TM, Martinez D, Turner C, Sanchez A, Ghermezi M, Eades BM, Swift RA, Schwartz G, Eshaghian S, Stampleman L, Moss RA, Lim S, Vescio R. A Phase I Study of Ruxolitinib, Lenalidomide, and Steroids for Patients with Relapsed/Refractory Multiple Myeloma. Clin Cancer Res. 2020 May 15;26(10):2346-2353. doi: 10.1158/1078-0432.CCR-19-1899. Epub 2020 Jan 14.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lenalidomide | Other / unclassified | 5 mg | Oral |
| Subject | Lenalidomide | Other / unclassified | 10 mg | Oral |
| Subject | Methylprednisolone | Other / unclassified | 40 mg | Oral |
| Subject | Ruxolitinib | Small molecule | 5 mg | Oral |
| Subject | Ruxolitinib | Small molecule | 10 mg | Oral |
| Subject | Ruxolitinib | Small molecule | 15 mg | Oral |
| Subject | Ruxolitinib | Small molecule | 20 mg | Oral |