Trials / Completed
CompletedNCT01632150
Safety Study of Elotuzumab in Combination With Thalidomide and Dexamethasone in Relapsed and/or Refractory Multiple Myeloma
Phase 2a Single-Arm Safety Study of Elotuzumab in Combination With Thalidomide and Dexamethasone in Subjects With Relapsed and/or Refractory Multiple Myeloma
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 51 (actual)
- Sponsor
- Bristol-Myers Squibb · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Elotuzumab | Powder for solution, 400-mg vials, for infusion |
| BIOLOGICAL | Thalidomide | 50-mg capsules administered orally |
| BIOLOGICAL | Dexamethasone | 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 | Cyclophosphamide | 50-mg tablets administered orally |
Timeline
- Start date
- 2012-05-01
- Primary completion
- 2013-10-01
- Completion
- 2016-03-01
- First posted
- 2012-07-02
- Last updated
- 2017-04-14
- Results posted
- 2016-02-26
Locations
10 sites across 1 country: Spain
Source: ClinicalTrials.gov record NCT01632150. Inclusion in this directory is not an endorsement.