Phase III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Newly Diagnosed, Previously Untreated Multiple Myeloma (ELOQUENT - 1)

• Objective Response Rate - The percentage of patients who have a partial or complete response to study therapy. [ Time Frame: All response endpoints assessed every 4 weeks (-1/+3 days). ] [ Designated as safety issue: No ]
• Overall Survival - The period of time from study entry until the date of death or last known date alive. [ Time Frame: Survival will be assessed every 16 weeks in the Follow Up Phase of the trial. ] [ Designated as safety issue: No ]

The purpose of the study is to determine whether the addition of Elotuzumab to Lenalidomide/low-dose Dexamethasone will increase the progression free survival (PFS)

• Drug: Lenalidomide
  Capsules, Oral, 25 mg, once daily, on Days 1-21, Repeat every 28 days until subject meets criteria for discontinuation of study drug
  Other Name: Revlimid®
• Drug: Dexamethasone
  Tablets, Oral, 40 mg, weekly, on Days 1, 8, 15, 22, Repeat every 28 days until subject meets criteria for discontinuation of study drug
  Other Names:

  • Decadron®
  • Dexamethasone Intensol®
  • Dexpak®
  • Taperpak®
• Drug: Dexamethasone
  Tablets, Oral, 28 mg, once daily, on Days 1, 8, 15, 22 (cycles 1&2) ; Days 1 &15 (cycles 3-18); Day 1 (cycle 19 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug
  Other Names:

  • Decadron®
  • Dexamethasone Intensol®
  • Dexpak®
  • Taperpak®
• Drug: Dexamethasone
  Tablets, Oral, 40 mg, once daily, on Days 8 & 22 (cycles 3-18); Days 8, 15, 22 (cycle 19 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug
  Other Names:

  • Decadron®
  • Dexamethasone Intensol®
  • Dexpak®
  • Taperpak®
• Drug: Dexamethasone
  Solution, Intravenous (IV), 8 mg, Once daily, on Days 1, 8, 15, 22 (cycles 1&2) ; Days 1 &15 (cycles 3-18); Day 1 (cycle 19 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug
  Other Names:

  • Decadron®
  • Dexamethasone Intensol®
  • Dexpak®
  • Taperpak®
• Biological: Elotuzumab (BMS-901608; HuLuc63)
  Solution, Intravenous (IV), 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1&2); Days 1 and 15 (cycles 3-18), Repeat every 28 days until subject meets criteria for discontinuation of study drug
• Biological: Elotuzumab (BMS-901608; HuLuc63)
  Solution, Intravenous (IV), 20 mg/kg, Day 1 (cycle 19 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug

• Active Comparator: Lenalidomide + Dexamethasone
  Interventions:

  • Drug: Lenalidomide
  • Drug: Dexamethasone
• Experimental: Lenalidomide + Dexamethasone + Elotuzumab
  Interventions:

  • Drug: Lenalidomide
  • Drug: Dexamethasone
  • Drug: Dexamethasone
  • Drug: Dexamethasone
  • Biological: Elotuzumab (BMS-901608; HuLuc63)
  • Biological: Elotuzumab (BMS-901608; HuLuc63)

Inclusion Criteria:

• Subjects who are newly diagnosed with symptomatic Multiple Myeloma (MM) and who:

  • have not received any prior systemic anti-myeloma therapy AND
  • have measurable disease AND
  • are not candidates for high-dose therapy plus stem-cell transplantation (SCT) because of age (≥ 65 years) or coexisting conditions. Refusal to undergo high dose therapy with SCT is NOT sufficient for entry onto CA204006 for a subject < 65 years old. There must be a comorbidity that prevents SCT for a subject < 65 years old

Exclusion Criteria:

• Subjects with non-secretory or oligo-secretory or free light-chain only myeloma
• Smoldering MM, defined as asymptomatic MM with absence of lytic bone lesions
• Monoclonal Gammopathy of Undetermined Significance (MGUS)
• Active plasma cell leukemia
• Known Human Immunodeficiency Virus (HIV) infection or active hepatitis A, B, or C