drugset / Trial / NCT01754402
Bendamustine + Pomalidomide + Dex in R/R Multiple Myeloma
Non-randomizedSequentialOpen-labelTreatment
Summary
This study is designed as a phase I-II, open label, dose finding study. Study treatment will be as follows, in 28 day cycles: * Pomalidomide: once daily orally (PO) dosing on days 1-21, every 28 days * Bendamustine: once intravenously (IV) dosing on day 1, every 28 days * Dexamethasone: weekly PO or IV dosing on days 1, 8, 15, and 22. After completing 6 cycles of treatment, dexamethasone may be decreased to 20mg per investigator discretion. After completing 12 cycles of treatment, patients will proceed to the maintenance phase of the study. Patients will receive Pomalidomide on day 1-21, every 28 days and dexamethasone on days 1, 8, 15, and 22 every 28 days until time of progression.
Timeline
- Start
- 2013-01-07
- Primary completion
- 2016-12-06
- Completion
- 2025-01-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bendamustine | Small molecule | 120 mg/m2 | Intravenous |
| Subject | Bendamustine | Small molecule | 150 mg/m2 | Intravenous |
| Subject | Bendamustine | Small molecule | 180 mg/m2 | Intravenous |
| Subject | Dexamethasone | Small molecule | 20 mg | Oral |
| Subject | Dexamethasone | Small molecule | 40 mg | Oral |
| Subject | Pomalidomide | Other / unclassified | 2 mg | Oral |
| Subject | Pomalidomide | Other / unclassified | 3 mg | Oral |
| Subject | Pomalidomide | Other / unclassified | 4 mg | Oral |