Clinical Trial: NCT02541383
A Study to Evaluate Daratumumab in Transplant Eligible Participants With Previously Untreated Multiple Myeloma
Status:
COMPLETEDPhase:
Phase 3| Lead Sponsor: | Intergroupe Francophone du Myelome |
| Information Provided By: | Intergroupe Francophone du Myelome |
| Last Update Posted: | 2025-04-13 |
Study Overview
Brief Summary
The purpose of this study is to evaluate if the addition of daratumumab to Bortezomib, Thalidomide and Dexamethasone will increase the stringent complete response rate after consolidation therapy and increase the progression free survival after daratumumab maintenance therapy in transplant eligible participants with previously untreated Multiple Myeloma.
Official Title
Study of Daratumumab in Combination With Bortezomib (VELCADE), Thalidomide, and Dexamethasone (VTD) in the First Line Treatment of Transplant Eligible Subjects With Newly Diagnosed Multiple Myeloma
Conditions
Multiple Myeloma
Intervention / Treatment
- Drug: Bortezomib (VELCADE), Thalidomide, and Dexamethasone (VTD)
- Drug: Bortezomib, Thalidomide, Dexamethasone (VTD) + daratumumab
- Drug: Daratumumab
Other Study ID Numbers
- IFM 2015-01
- HO131
- 54767414MMY3006
- 2014-004781-15
- 2014
Start Date (Actual)
2015-09
Primary Completion Date (Actual)
2020-08-27
Study Completion Date (Actual)
2023-09-01
Enrollment (Actual)
1085
Study Type
Interventional
Phase
Phase 3
| Lead Sponsor: | Intergroupe Francophone du Myelome |
| Information Provided By: | Intergroupe Francophone du Myelome |
| Last Update Posted: | 2025-04-13 |
Study Overview
Brief Summary
The purpose of this study is to evaluate if the addition of daratumumab to Bortezomib, Thalidomide and Dexamethasone will increase the stringent complete response rate after consolidation therapy and increase the progression free survival after daratumumab maintenance therapy in transplant eligible participants with previously untreated Multiple Myeloma.
Official Title
Study of Daratumumab in Combination With Bortezomib (VELCADE), Thalidomide, and Dexamethasone (VTD) in the First Line Treatment of Transplant Eligible Subjects With Newly Diagnosed Multiple Myeloma
Conditions
Multiple Myeloma
Intervention / Treatment
- Drug: Bortezomib (VELCADE), Thalidomide, and Dexamethasone (VTD)
- Drug: Bortezomib, Thalidomide, Dexamethasone (VTD) + daratumumab
- Drug: Daratumumab
Other Study ID Numbers
- IFM 2015-01
- HO131
- 54767414MMY3006
- 2014-004781-15
- 2014
Start Date (Actual)
2015-09
Primary Completion Date (Actual)
2020-08-27
Study Completion Date (Actual)
2023-09-01
Enrollment (Actual)
1085
Study Type
Interventional
Phase
Phase 3