drugset / Trial / NCT02477215
Study of Bendamustine and IXAZOMIB (MLN9708) Plus Dexamethasone in Relapsed/Refractory Multiple Myeloma
Non-randomizedSingle-groupOpen-labelTreatment
Summary
This Phase I/II study is designed to first identify doses of MLN9708 and bendamustine that are associated with an acceptable adverse event profile when delivered together in 28-day cycles. Additionally, the study aims to assess the efficacy of the combination in patients with relapsed/refractory multiple myeloma. Responders (stable disease or more), will continue to receive up to eight cycles total in the absence of further progressive disease.
Timeline
- Start
- 2015-10-09
- Primary completion
- 2018-05-02
- Completion
- 2020-09-17
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bendamustine | Small molecule | 70 mg/m2 | — |
| Subject | Bendamustine | Small molecule | 80 mg/m2 | — |
| Subject | Bendamustine | Small molecule | 90 mg/m2 | — |
| Background | Dexamethasone | Small molecule | 40 mg | Oral |
| Background | Ixazomib | Unknown | 4 mg | — |