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Phase 3, Randomized, Open Label Trial of Lenalidomide/Dexamethasone With or Without Elotuzumab in Relapsed or Refractory Multiple Myeloma (MM)

Phase 3
18 Years
Open (Enrolling)
Multiple Myeloma

Thank you

Trial Information

Phase 3, Randomized, Open Label Trial of Lenalidomide/Dexamethasone With or Without Elotuzumab in Relapsed or Refractory Multiple Myeloma (MM)

Inclusion Criteria:

- Documented progression from most recent line of therapy

- 1 - 3 prior lines of therapy

- Measurable disease

- Life expectancy ≥3 months

- Prior treatment with Lenalidomide permitted if:

1. Best response achieved was ≥ Partial Response (PR)

2. Patient was not refractory

3. Patient did not discontinue due to a Grade ≥ 3 related adverse event

4. Subject did not receive more than 9 cycles of Lenalidomide and had at least 9
months between the last dose of Lenalidomide and progression

Exclusion Criteria:

- Subjects with non-secretory or oligo-secretory or serum free light-chain only myeloma

- 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:

Tumor assessments every 4 weeks (±1 week) relative to the first dose of study medication (median length of time for tumor assessments should be approximately 13 months)

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:

June 2011

Completion Date:

October 2017

Related Keywords:

  • Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell



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