Phase III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Newly Diagnosed, Previously Untreated Multiple Myeloma
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: Lenalidomide; Dexamethasone; Dexamethasone; Dexamethasone; Dexamethasone; Elotuzumab (BMS-901608; HuLuc63); Elotuzumab (BMS-901608; HuLuc63)
Intervention description: Capsules, Oral, 25 mg, once daily, on Days 1-21, Repeat every 28 days until subject meets criteria for discontinuation of study drug; Tablets, Oral, 40 mg, weekly, on Days 1, 8, 15, 22, Repeat every 28 days until subject meets criteria for discontinuation of study drug; 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; 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; 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; 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; 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
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; Lenalidomide; Elotuzumab; BB 1101
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 748.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Newly Diagnosed; Previously Untreated

Summary:

      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)
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com.

        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