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

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

August 27, 2010

Primary Completion Date

November 6, 2015

Study Completion Date

May 18, 2019

Conditions
Multiple Myeloma
Interventions
DRUG

Lenalidomide plus Melphalan during autologous stem cell transplantation

Patients will receive a fixed dose of melphalan, while the dose of lenalidomide is escalated according to the protocol defined cohorts. Lenalidomide is given on day -7 to day +2, while intravenous melphalan is given on day -2 and -1. Lenalidomide dosing will be in the morning at approximately the same time each day.

DRUG

Lenalidomide maintenance

Lenalidomide maintenance therapy will begin on Day +100 to Day +110 provided the protocol-defined criteria are met. The initial starting dose of lenalidomide during maintenance is 10 mg daily on Days 1-28 of each 28-day cycle.

Trial Locations (1)

46202

IU Simon Cancer Center, Indianapolis

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Celgene

INDUSTRY

lead

Attaya Suvannasankha

OTHER