Safety Study of Elotuzumab in Combination With Thalidomide and Dexamethasone in Relapsed and/or Refractory Multiple Myeloma
NCT01632150 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 51
Last updated 2017-04-14
Summary
The purpose of this study is to determine the safety and tolerability of elotuzumab administered in combination with thalidomide and dexamethasone in the treatment of relapsed and/or refractory multiple myeloma.
Conditions
- Relapsed and/or Refractory Multiple Myeloma
Interventions
- BIOLOGICAL
-
Elotuzumab
Powder for solution, 400-mg vials, for infusion
- BIOLOGICAL
-
Thalidomide
50-mg capsules administered orally
- BIOLOGICAL
-
2- and 4-mg tablets (and various other strengths, as needed) administered orally and in 4- and 8-mg/mL (and various other strengths, as needed) solutions for intravenous administration
- BIOLOGICAL
-
50-mg tablets administered orally
Sponsors & Collaborators
- collaborator INDUSTRY
- lead INDUSTRY
Principal Investigators
-
Bristol-Myers Squibb · Bristol-Myers Squibb
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-05-31
- Primary Completion
- 2013-10-31
- Completion
- 2016-03-31
Countries
- Spain
Study Locations
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