A Study Being Conducted at Multiple Locations to Compare Safety and Efficacy of Three Different Regimens; (1) High-Dose Lenalidomide; (2) Lenalidomide + Azacitidine; or (3) Azacitidine in Subjects ≥ 65 Years With Newly-Diagnosed Acute Myeloid Leukemia

A Phase 2, Multicenter, Randomized, Open-label, Parallel-group Study of a Lenalidomide (Revlimid®) Regimen or a Sequential Azacitidine (Vidaza®) Plus Lenalidomide (Revlimid®) Regimen Versus an Azacitidine (Vidaza®) Regimen for Therapy of Older Subjects With Newly Diagnosed Acute Myeloid Leukemia

The study aim is to compare safety and efficacy of high-dose lenalidomide regimen, sequential azacitidine and lenalidomide and an azacitidine in persons ≥65 years with newly-diagnosed acute myeloid leukemia (AML).

On September 11, 2013, randomization into the continuous 50 mg lenalidomide only arm was temporarily suspended based on review of the data from the first 13 participants and a high rate of discontinuation (11/13 participants). The Data Monitoring Committee assessed the study data on September 20, 2013 and reported no safety concerns. The high rate of early discontinuation is inconsistent with the treatment duration required for testing the study primary endpoint of survival at one year. Consequently, Celgene has decided not to reopen the lenalidomide only arm.

Inclusion Criteria:

• Newly diagnosed acute myeloid leukemia (AML), AML with antecedent hematologic disorder or therapy-related AML
• Male or female subjects aged ≥ 65
• Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
• White blood cell (WBC) count ≤ 10 x 10⁹/L at screening

Exclusion Criteria:

• Previous treatment with azacitidine, decitabine, cytarabine or lenalidomide
• Previous cytotoxic or biologic treatment of any kind for AML or prior use of targeted therapy agents.
• Suspected or proven acute promyelocytic leukemia
• Prior bone marrow or stem cell transplantation
• Candidate for allogeneic bone marrow or stem cell transplantation
• AML antecedent hematologic disorder such as chronic myelogenous leukemia or myeloproliferative neoplasms
• Presence of malignant disease within the previous 12 months with exceptions