A Multicentre, Single-arm, Open-label Safety Study of Lenalidomide Plus Dexamethasone in Previously Treated Subjects With Multiple Myeloma

PHASE3CompletedINTERVENTIONAL
Enrollment

587

Participants

Timeline

Start Date

November 30, 2006

Primary Completion Date

October 31, 2009

Study Completion Date

November 30, 2009

Conditions
Multiple Myeloma
Interventions
DRUG

Lenalidomide

Oral lenalidomide at a dose of 25 mg daily for 21 days every 28 days. Treatment as tolerated until disease progression, drug became commercially available or limited to 6 treatment cycles.

DRUG

Dexamethasone

Oral pulse dexamethasone at a dose of 40 mg daily on days 1-4, 9-12, and 17-20 for each 28-day-cycle for cycles 1 through 4. Beginning cycle 5, a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle.

Trial Locations (5)

1160

Wilhelminenspital, Vienna

QLD 4101

The Mater Private Centre for Haematology & Oncology, South Brisbane

Unknown

St James's Hospital, Dublin

H. Clínico de Salamanca, Salamanca

NW3 2QG

Royal Free Hospital & Medical School, London

Sponsors
All Listed Sponsors
lead

Celgene Corporation

INDUSTRY