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

NCT02075021 ↗

Phase 1/2 Terminated 3 enrolled NYU Langone Health Celgene Corporation · collab
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

EvaluationDrugModalityDoseRoute
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 —