drugset / Trial / NCT00687674

Sorafenib, Lenalidomide, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma

NCT00687674 ↗

NaSingle-groupOpen-labelTreatment

Summary

RATIONALE: Sorafenib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Lenalidomide may stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Sorafenib and lenalidomide may also stop the growth of cancer cells by blocking blood flow to the cancer. Giving sorafenib 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 sorafenib when given together with lenalidomide and dexamethasone and to see how well they work in treating patients with relapsed or refractory multiple myeloma.

Timeline

Start
2008-08
Primary completion
2011-11
Completion
2011-11

Outcome

Outcome not reported

Stopped (Enrollment): “Due to study design (and toxicity), this trial closed to accrual prior to opening the phase II portion.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Lenalidomide Other / unclassified 5 mg Oral
Subject Lenalidomide Other / unclassified 10 mg Oral
Subject Lenalidomide Other / unclassified 15 mg Oral
Subject Lenalidomide Other / unclassified 25 mg Oral
Subject Sorafenib Small molecule 200 mg Oral
Subject Sorafenib Small molecule 400 mg Oral
Background Dexamethasone Small molecule 20 mg Oral

Indications