A Study Being Conducted at Multiple Locations to Compare the Safety and Effectiveness of Three Different Treatment Regimens; 1) Lenalidomide, 2) Lenalidomide + Azacitidine, or 3) Azacitidine Alone in Newly Diagnosed Acute Myeloid Leukemia in Elderly Subjects ≥ 65 Years of Age

• Number of elderly subjects in remission [ Time Frame: Approximately 12 months ] [ Designated as safety issue: No ]
• Duration of remission [ Time Frame: Approximately 12 months ] [ Designated as safety issue: No ]
• Number of elderly subjects with a cytogenetic complete remission rate [ Time Frame: Approximately 12 months ] [ Designated as safety issue: No ]
• Number of elderly subjects who have a response (Complete Remissions plus Morphologic Complete Remissions with incomplete blood count recovery plus Partial Remissions) [ Time Frame: Approximately 12 months ] [ Designated as safety issue: No ]
• Number of elderly subjects who survive without worsening of disease [ Time Frame: Approximately 12 months ] [ Designated as safety issue: No ]
• Number of elderly subjects who survive without an event [ Time Frame: Approximately 12 months ] [ Designated as safety issue: No ]
• Number of elderly subjects who survive without relapsing [ Time Frame: Approximately 12 months ] [ Designated as safety issue: No ]
• Number of elderly subjects who died [ Time Frame: 30 days ] [ Designated as safety issue: No ]
• Number of elderly subjects with adverse events [ Time Frame: Approximately 12 months ] [ Designated as safety issue: Yes ]

• Number of participants in remission [ Time Frame: Approximately 12 months ] [ Designated as safety issue: No ]
• Duration of remission [ Time Frame: Approximately 12 months ] [ Designated as safety issue: No ]
• Number of participants with a cytogenetic complete remission rate [ Time Frame: Approximately 12 months ] [ Designated as safety issue: No ]
• Number of participants who have a response (Complete Remissions plus Morphologic Complete Remissions with incomplete blood count recovery plus Partial Remissions) [ Time Frame: Approximately 12 months ] [ Designated as safety issue: No ]
• Number of participants who survive without worsening of disease [ Time Frame: Approximately 12 months ] [ Designated as safety issue: No ]
• Number of participants who survive without an event [ Time Frame: Approximately 12 months ] [ Designated as safety issue: No ]
• Number of participants who survive without relapsing [ Time Frame: Approximately 12 months ] [ Designated as safety issue: No ]
• Number of participants who died [ Time Frame: 30 days ] [ Designated as safety issue: No ]
• Number of participants with adverse events [ Time Frame: Approximately 12 months ] [ Designated as safety issue: Yes ]

The aim of the study is to investigate the effect of a lenalidomide regimen, a sequential azacitidine plus lenalidomide regimen or an azacitidine regimen in elderly subjects 65 years or older with newly diagnosed AML.

• Acute Myeloid Leukemia
• Acute Myelogenous Leukemia

• Drug: Azacitidine-single agent
  Azacitidine at 75 mg/m2/day subcutaneous on Days 1-7
  Other Name: Azacitidine
• Drug: Lenalidomide - single agent
  Lenalidomide 50 mg/day by mouth x 28 days for the first 2 cycles and lenalidomide 25 mg/day by mouth x 28 days for the next 2 cycles followed by continuous 28-day cycles of lenalidomide 10 mg/day by mouth
  Other Name: Revlimid
• Drug: Lenalidomide in combination with azacitidine
  Repeated cycles of azacitidine 75 mg/m2/day subcutaneous on Days 1-7 and lenalidomide 50 mg/day by mouth on Days 8-28 followed by a 14-day break plus best supportive care
  Other Names:

  • Azacitidine
  • Lenalidomide

• Experimental: Lenalidomide in combination with azacitidine
  Repeated cycles of azacitidine 75 mg/m2/day subcutaneous on Days 1-7 and lenalidomide 50 mg/day by mouth on Days 8-28 followed by a 14-day break plus best supportive care
  Interventions:

  • Drug: Azacitidine-single agent
  • Drug: Lenalidomide in combination with azacitidine
• Experimental: Lenalidomide - single agent
  Lenalidomide 50 mg/day by mouth for 28 days for the first 2 cycles and lenalidomide 25 mg/day by mouth for 28 days for the next 2 cycles followed by continuous 28-day cycles of lenalidomide 10 mg/day by mouth plus best supportive care
  Intervention: Drug: Lenalidomide - single agent
• Experimental: Azacitidine-single agent
  Repeated cycles of azacitidine 75mg/m2/day subcutaneous on Days 1-7 followed by a 21-day break plus best supportive care
  Intervention: Drug: Azacitidine-single agent

Inclusion Criteria:

• Newly diagnosed acute myelogenous leukemia (AML), in elderly patients, AML with antecedent hematologic disorder, or therapy-related AML
• Elderly 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
• White blood cell (WBC) count > 10 x 10⁹/L at screening
• Presence of malignant disease within the previous 12 months with exceptions.