drugset / Trial / NCT01754402

Bendamustine + Pomalidomide + Dex in R/R Multiple Myeloma

NCT01754402

Phase 1/2 Unknown 56 enrolled Cristina Gasparetto Celgene Corporation · collab
Non-randomizedSequentialOpen-labelTreatment

Summary

This study is designed as a phase I-II, open label, dose finding study. Study treatment will be as follows, in 28 day cycles: * Pomalidomide: once daily orally (PO) dosing on days 1-21, every 28 days * Bendamustine: once intravenously (IV) dosing on day 1, every 28 days * Dexamethasone: weekly PO or IV dosing on days 1, 8, 15, and 22. After completing 6 cycles of treatment, dexamethasone may be decreased to 20mg per investigator discretion. After completing 12 cycles of treatment, patients will proceed to the maintenance phase of the study. Patients will receive Pomalidomide on day 1-21, every 28 days and dexamethasone on days 1, 8, 15, and 22 every 28 days until time of progression.

Timeline

Start
2013-01-07
Primary completion
2016-12-06
Completion
2025-01-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Bendamustine Small molecule 120 mg/m2 Intravenous
Subject Bendamustine Small molecule 150 mg/m2 Intravenous
Subject Bendamustine Small molecule 180 mg/m2 Intravenous
Subject Dexamethasone Small molecule 20 mg Oral
Subject Dexamethasone Small molecule 40 mg Oral
Subject Pomalidomide Other / unclassified 2 mg Oral
Subject Pomalidomide Other / unclassified 3 mg Oral
Subject Pomalidomide Other / unclassified 4 mg Oral

Indications