drugset / Trial / NCT01383928
Study of Oral IXAZOMIB in Combination With Lenalidomide and Dexamethasone in Participants With Newly Diagnosed Multiple Myeloma
Non-randomizedSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to determine the safety, tolerability, maximum tolerated dose (MTD), and recommended phase 2 dose (RP2D) in phase 1 and to determine the combined response rate of clinical response CR and very good partial response (VGPR) in phase 2 of oral (PO) ixazomib administered twice-weekly in combination with lenalidomide and low-dose dexamethasone in a 21-day cycle in participants with newly diagnosed multiple myeloma (NDDM).
Timeline
- Start
- 2011-10-31
- Primary completion
- 2014-10-13
- Completion
- 2017-11-27
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ixazomib | Unknown | 3 mg | Oral |
| Subject | Ixazomib | Unknown | 3.7 mg | Oral |
| Background | Dexamethasone | Small molecule | — | Oral |
| Background | Lenalidomide | Other / unclassified | — | Oral |