Trials / Completed
CompletedNCT01850524
IXAZOMIB Plus Lenalidomide and Dexamethasone Versus Placebo Plus Lenalidomide and Dexamethasone in Adult Patients With Newly Diagnosed Multiple Myeloma
A Phase 3, Randomized, Double-Blind, Multicenter Study Comparing Oral MLN9708 Plus Lenalidomide and Dexamethasone Versus Placebo Plus Lenalidomide and Dexamethasone in Adult Patients With Newly Diagnosed Multiple Myeloma
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 705 (actual)
- Sponsor
- Millennium Pharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to provide continued access to ixazomib and/or lenalidomide to participants who are continuing to have clinical benefit and to continue collecting relevant safety data to monitor safety in participants with Newly Diagnosed Multiple Myeloma (NDMM) who are not eligible for stem cell transplant.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Ixazomib | IXAZOMIB capsules. |
| DRUG | Placebo | IXAZOMIB matching-placebo capsules. |
| DRUG | Dexamethasone | Dexamethasone tablets. |
| DRUG | Lenalidomide | Lenalidomide capsules. |
Timeline
- Start date
- 2013-04-29
- Primary completion
- 2019-12-02
- Completion
- 2022-06-24
- First posted
- 2013-05-09
- Last updated
- 2023-07-21
- Results posted
- 2021-02-01
Locations
147 sites across 7 countries: United States, Belgium, Canada, France, New Zealand, Russia, South Korea
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT01850524. Inclusion in this directory is not an endorsement.