drugset / Trial / NCT02004275
Pomalidomide and Dexamethasone With or Without Ixazomib in Treating Patients With Relapsed Multiple Myeloma
Phase 1/2
Unknown
118 enrolled
Alliance for Clinical Trials in Oncology
Celgene Corporation · collabMillennium Pharmaceuticals, Inc. · collabNational Cancer Institute (NCI) · collab
RandomizedCrossoverOpen-labelTreatment
Summary
This randomized phase I/II trial studies the side effects and best dose of pomalidomide and ixazomib when given together with dexamethasone and to see how well pomalidomide and dexamethasone with or without ixazomib works in treating patients with multiple myeloma that has come back. Biological therapies, such as pomalidomide and dexamethasone, may stimulate the immune system in different ways and stop cancer cells from growing. Ixazomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. It is not yet known whether pomalidomide and dexamethasone are more effective with or without ixazomib in treating multiple myeloma.
Timeline
- Start
- 2014-02
- Primary completion
- 2021-12-01
- Completion
- —
Publications
- Voorhees P, Suman V, Efebera Y, Raje N, Tuchman S, Rodriguez C, Laubach J, Bova-Solem M, Carlisle D, Usmani S, McCarthy P, Richardson PG. Alliance A061202: ixazomib, pomalidomide, and dexamethasone for patients with lenalidomide-refractory MM in first relapse. Blood Adv. 2024 Oct 8;8(19):5039-5050. doi: 10.1182/bloodadvances.2024013623.
- Voorhees PM, Suman VJ, Tuchman SA, Laubach JP, Hassoun H, Efebera YA, Mulkey F, Bova-Solem M, Santo K, Carlisle D, McCarthy PL, Richardson PG. A phase I/II study of ixazomib, pomalidomide, and dexamethasone for lenalidomide and proteasome inhibitor refractory multiple myeloma (Alliance A061202). Am J Hematol. 2021 Dec 1;96(12):1595-1603. doi: 10.1002/ajh.26361. Epub 2021 Oct 6.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dexamethasone | Small molecule | 20 mg | Oral |
| Subject | Ixazomib | Unknown | 4 mg | Oral |
| Subject | Pomalidomide | Other / unclassified | 4 mg | Oral |