drugset / Trial / NCT01155583

Low-Dose Azacitidine, Lenalidomide, and Low-Dose Dexamethasone in Relapsed or Refractory Multiple Myeloma

NCT01155583

Phase 1/2 Completed 45 enrolled Case Comprehensive Cancer Center
Non-randomizedParallel-groupOpen-labelTreatment

Summary

RATIONALE: Drugs used in chemotherapy, such as azacitidine and dexamethasone, work in different ways to stop the growth of cancer cells either by killing the cells or by stopping them from dividing. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Giving azacitidine together with lenalidomide and dexamethasone may kill more cancer cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of azacitidine when given together with lenalidomide and low-dose dexamethasone in treating patients with relapsed or refractory multiple myeloma.

Timeline

Start
2010-06
Primary completion
2016-05-28
Completion
2018-11-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Azacitidine Other / unclassified 30 mg/m2 Subcutaneous
Subject Azacitidine Other / unclassified 40 mg/m2 Subcutaneous
Subject Azacitidine Other / unclassified 50 mg/m2 Subcutaneous
Subject Dexamethasone Small molecule 40 mg Oral
Subject Lenalidomide Other / unclassified 10 mg Oral
Subject Lenalidomide Other / unclassified 25 mg Oral