drugset / Trial / NCT01142232

Lenalidomide and High Dose Melphalan Followed by Autologous Stem Cell Transplant in Multiple Myeloma

NCT01142232

Phase 1/2 Completed 60 enrolled Attaya Suvannasankha Celgene Corporation · collab
SequentialOpen-labelTreatment

Summary

This is a research study for newly diagnosed multiple myeloma or multiple myeloma has returned (relapsed). Multiple myeloma is a type of cancer that begins in white blood cells called plasma cells. Plasma cells make proteins that help fight infections. Current therapy for multiple myeloma includes high dose chemotherapy and autologous (patient's own cells) stem cell transplantation. There will be two parts (or phases) to this study: The purpose of the first part is to find the highest dose of a drug called lenalidomide (Revlimid®) that can be given in combination with high dose melphalan without causing severe adverse events. The purpose of the second part is to find out the effects of this treatment (good and bad) on multiple myeloma patients.

Timeline

Start
2010-08-27
Primary completion
2015-11-06
Completion
2019-05-18

Drugs

EvaluationDrugModalityDoseRoute
Subject Lenalidomide Other / unclassified 10 mg
Subject Lenalidomide Other / unclassified 25 mg
Subject Lenalidomide Other / unclassified 50 mg
Subject Lenalidomide Other / unclassified 75 mg
Subject Lenalidomide Other / unclassified 100 mg
Subject Lenalidomide Other / unclassified 150 mg
Background Melphalan Small molecule 100 mg/m2 Intravenous

Indications