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Lenalidomide and prednisone for myelofibrosis: Eastern Cooperative Oncology Group (ECOG) phase-2 trial E4903.

Author(s): Mesa RA, Yao X, Cripe LD, Li CY, Litzow M, Paietta E, Rowe JM, Tefferi A, Tallman MS

Affiliation(s): Mayo Clinic, Scottsdale, AZ;

Publication date & source: 2010-07-22, Blood., [Epub ahead of print]

A multi-center Eastern Cooperative Group (ECOG) phase-2 trial assessed whether adding prednisone to lenalidomide would improve previously reported responses in persons with myelofibrosis (MF). 48 subjects with anemia (42 evaluable) received lenalidomide, 10 mg/d, with a 3 month low-dose prednisone taper. 10 subjects received 3 months, and 25, 6 months of therapy. Myelosuppression was the main toxicity with 88% with >/=grade-3 hematologic toxicity and 45% >/=grade-3 non-hematologic toxicity. There were responses in 10 subjects (23%) using the IWG-MRT-defined clinical improvement of anemia in 8 (19%) and/or decreased spleen size in 4 (10%). Serial bone marrow analysis showed no resolution of disease-related fibrosis or angiogenesis. With a median follow-up of 2.3 years 23 subjects are alive. Lenalidomide and prednisone for myelofibrosis evaluated through a multi-centered - cooperative group mechanism is only modestly active and myelosuppresive. This study was registered at http://clinicaltrials.gov as NCT00227591.

Page last updated: 2010-10-05

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