Conditions: Multiple Myeloma
Keywords: Multiple Myeloma Revlimid
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 330
Healthy volunteers: no

Brief summary:
The study evaluated the safety of Lenalidomide monotherapy in participants with advanced multiple myeloma who had discontinued treatment with combination thalidomide plus high-dose dexamethasone or high-dose dexamethasone alone in studies Thal-MM-003, CC-5013-MM-009 and CC-5013-MM-010 due to the development of documented disease progression or the inability to tolerate the lowest dosing regimen per previous protocol of thalidomide and/or high-dose dexamethasone without grade 3 or 4 toxicity.

Detailed description:

Arms:
arm 1: Oral 25mg daily on Days 1-21 every 28 days

Interventions: intervention 1: CC-5013 intervention 2: Lenalidomide
Intervention descriptions: intervention 1: Oral 25mg daily on Days 1-21 every 28 days. intervention 2: Oral Lenalidomide 25mg daily on Days 1-21 every 28 days.

Protocol document: