drugset / Trial / NCT03731832
Pomalidomide, Ixazomib, and Dexamethasone With or Without Intensification by Cyclophosphamide in Relapsed or Refractory Multiple Myeloma
Non-randomizedSequentialOpen-labelScreening
Summary
The study is designed as a multicenter, non-randomized, Phase II trial with one treatment arm. A total of 82 patients of both genders and older than 18 years with relapsed/refractory multiple myeloma are planned to be included in the study. After the first 6 patients will have finished the first treatment cycle of the induction phase the DMC will assess safety and tolerability of the treatment schedule and decide about the further continuation of the study.
Timeline
- Start
- 2018-09-20
- Primary completion
- 2024-04-22
- Completion
- 2024-04-22
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cyclophosphamide | Other / unclassified | 50 mg | Oral |
| Subject | Dexamethasone | Small molecule | 20 mg | Oral |
| Subject | Dexamethasone | Small molecule | 40 mg | Oral |
| Subject | Ixazomib | Unknown | 4 mg | Oral |
| Subject | Pomalidomide | Other / unclassified | 4 mg | Oral |