drugset / Trial / NCT01745588

Autologous Stem Cell Transplant With Pomalidomide (CC-4047®) Maintenance Versus Continuous Clarithromycin/ Pomalidomide / Dexamethasone Salvage Therapy in Relapsed or Refractory Multiple Myeloma

NCT01745588

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to see whether pomalidomide (also known as Pomalyst) reduces the number of myeloma cells in the bones, and to see what is the best way to use pomalidomide in patients with myeloma. To do this, the investigators want to compare two types of treatment using pomalidomde. This is a randomized trial which means that the decision as to which treatment the patient will receive will be made by a computer, much like flipping a coin. All patients start by receiving 4 cycles of clarithromycin, pomalidomide and dexamethasone (ClaPD). After 4 cycles, half of the patients will undergo an autologous stem cell transplant followed by pomalidomide (Group 1). The other half of the patients will continue to receive ClaPD for 9 cycles to be followed by pomalidomide maintenance. (Group 2). At the end of the study, the two groups will be compared to see if there is a difference in disease outcome.

Timeline

Start
2012-12
Primary completion
2025-09-03
Completion
2025-09-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Clarithromycin Small molecule 500 mg
Subject Dexamethasone Small molecule 40 mg Oral
Subject Pomalidomide Other / unclassified 4 mg

Indications