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A Phase 3, Randomized, Open Label Trial of Lenalidomide/Dexamethasone With or Without Elotuzumab in Subjects With Previously Untreated Multiple Myeloma

Phase 3
18 Years
Open (Enrolling)
Multiple Myeloma

Thank you

Trial Information

A Phase 3, Randomized, Open Label Trial of Lenalidomide/Dexamethasone With or Without Elotuzumab in Subjects With Previously Untreated Multiple Myeloma

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival (PFS) - Time from randomization to date of first tumor progression or death due to any cause, provided death is not more than 10 weeks after the last tumor assessment.

Outcome Time Frame:

Every 4 weeks (-1/+3 days) relative to the first dose of study medication.

Safety Issue:


Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb


Australia: Department of Health and Ageing Therapeutic Goods Administration

Study ID:




Start Date:

August 2011

Completion Date:

November 2018

Related Keywords:

  • Multiple Myeloma
  • Newly Diagnosed
  • Previously Untreated
  • Multiple Myeloma
  • Neoplasms, Plasma Cell



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