Safety Study of Lenalidomide Maintenance Therapy Post Allogeneic HCT for High-risk Multiple Myeloma
Status:
Completed
Trial end date:
2014-03-01
Target enrollment:
Participant gender:
Summary
This is a multi-institution, non-randomized, open label, Phase IIa prospective trial to
evaluate the safety and tolerability of maintenance lenalidomide after allogeneic
hematopoietic stem cell transplantation (HCT).
Lenalidomide maintenance therapy will start between day 60 and 90 after allogeneic HCT at a
starting dose of 10mg PO once daily. Dose escalation and de-escalation will be performed
depending on tolerability of lenalidomide. Dose range is 5mg every other day to 5 - 25 mg
given daily on days 1-21 of a 28-day cycle for 12 cycles maximum or maximum of 12 months from
first dose of study drug.
Patients will be followed until 28 days from completing the 12th planned cycle of
lenalidomide maintenance or 12 months from first dose of study drug, which ever comes first,
(14 to 15 months after receiving the allograft) or discontinuation of study drug.
Phase:
Phase 2
Details
Lead Sponsor:
Center for International Blood and Marrow Transplant Research