A Multi-center, Open-Label Phase II Study to Determine the Efficacy and Safety of Lenalidomide Plus Low-Dose Dexamethasone in Chinese Subjects With Relapsed/Refractory Multiple Myeloma
This is a Phase II, multicenter, single arm, open-label trial which will enroll Chinese
subjects in China with relapsed/refractory multiple myeloma that will assess the efficacy
and safety of lenalidomide plus low-dose dexamethasone regimen (Rd) given until progressive
disease (PD) or discontinuation of lenalidomide for any reason.
There are two cohorts in this protocol, Pharmacokinetic Assessment Treatment Cohort and
Treatment Cohort without Pharmacokinetic (PK) Assessment. The first 10 subjects who are ≤
75 years old and have a baseline Creatinine Clearance ≥ 60 mL/min will participate in
pharmacokinetic assessment during the first 8 days of Cycle 1. During this cohort, all
subjects will receive 25mg oral lenalidomide once daily on days 1 -21 of each 28-day cycle.
During the first cycle of this cohort, subjects will also receive 40mg oral dexamethasone
daily on Days 8, 15, and 22 (and no dexamethasone on day 1). Beginning with Cycle 2,
subjects will receive 25mg oral lenalidomide once daily on days 1 -21 of each 28-day cycle
and 40mg oral dexamethasone daily on Days 1, 8, 15 and 22 of each 28-day cycle.
Once 10 subjects have been enrolled in the PK Assessment Treatment Cohort, the Treatment
Cohort without PK Assessment will begin. During this cohort, subjects will receive
lenalidomide 25 mg p.o. once daily on Days 1-21 and dexamethasone 40 mg p.o. once daily on
Days 1, 8, 15, and 22 of each 28-day cycle. In both cohorts, subjects will continue Rd
therapy until the documentation of PD or discontinuation of study therapy due to any reason
including intolerable toxicity.
For the primary analysis, response will be assessed according to the European Group for
Blood and Marrow Transplantation EBMT (Bladé) criteria by an Independent Response
Adjudication Committee (IRAC). Response will also be assessed according to the
International Myeloma Working Group (IMWG) criteria and used as an exploratory analysis.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall Response Rate
Complete Response (CR) or partial Response (PR) using the European Group for Blood and Marrow Tranplantation (EBMT) (Bladé) criteria.
Up to 24 months
Jay Mei, M.D.
China: Food and Drug Administration