drugset / Trial / NCT02075021
Phase I/II Trial of the Combination of Lenalidomide (Revlimid) and Nab-paclitaxel (Abraxane) in the Treatment of Relapsed/Refractory Multiple Myeloma
NaSingle-groupOpen-labelTreatment
Summary
The investigators will perform a phase I/II trial of Revlimid daily for 21 days and Abraxane weekly for 3 weeks. Accrual will be on standard cohorts of 3 patients. Once the maximum toxicity dose (MTD) is reached, the level below will be expanded to 25 patients for a pilot phase II trial. All treatments will be performed until progression. Assessments will be made at least at the 2, 4 and 6 month timepoints and monthly thereafter until progression. The purpose of this research study is to determine how much of the combination of Revlimid and Abraxane can be given safely and how well they work together against the cancer. Currently, this trial is in the phase 1 stage.
Timeline
- Start
- 2014-03
- Primary completion
- 2015-11
- Completion
- 2015-11
Outcome
Outcome not reported
Stopped: “PI left the institution”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lenalidomide | Other / unclassified | 10 mg | — |
| Subject | Lenalidomide | Other / unclassified | 15 mg | — |
| Subject | Lenalidomide | Other / unclassified | 25 mg | — |
| Subject | Nab-paclitaxel | Small molecule | 100 mg/m2 | — |