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NCT01850524 · ClinicalTrials.gov registry record · Phase 3
IXAZOMIB Plus Lenalidomide and Dexamethasone Versus Placebo Plus Lenalidomide and Dexamethasone in Adult Patients With Newly Diagnosed Multiple Myeloma
A Phase 3 study, sponsored by Millennium Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 705
- Enrollment target
NCT01850524: Completed Phase 3 study, sponsored by Millennium Pharmaceuticals.
NCT01850524 is a Phase 3 study that has completed, run by Millennium Pharmaceuticals. The registered enrollment target is 705 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01850524, a Phase 3 study, has completed, sponsored by Millennium Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 705 participants
- Enrollment target
Study 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.
Primary Outcome
PFS was defined as the time from the date of randomization to the date of first documentation of progressive disease (PD) or death due to any cause according to International Myeloma Working Group (IMWG) criteria whichever occurs first. PD required one of the following: Increase of \>=25% from nadir in: Serum M-component and/or (the absolute increase must be \>=0.5 g/dL); Urine M-component and/or (the absolute increase must be \>=200 mg/24 hours); in participants without measurable serum and uri
Interventions
- DRUG Placebo
- DRUG Dexamethasone
- DRUG Lenalidomide
- DRUG Ixazomib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 705 participants |
| Start Date | 2013-04-29 |
| Est. Completion | 2022-06-24 |
| Phase | Phase 3 |
What the finished NCT01850524 record still lists
NCT01850524 is an interventional study that assigns participants to a tested intervention. The registered 705 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT01850524 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01850524 about?
NCT01850524 is a clinical study titled "IXAZOMIB Plus Lenalidomide and Dexamethasone Versus Placebo Plus Lenalidomide and Dexamethasone in Adult Patients With Newly Diagnosed Multiple Myeloma". 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...
What is the current status of trial NCT01850524?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 705 participants. The study started on 2013-04-29. Estimated completion is 2022-06-24.
What interventions are being tested in trial NCT01850524?
The interventions under investigation include: Placebo (DRUG), Dexamethasone (DRUG), Lenalidomide (DRUG), Ixazomib (DRUG).
Who is sponsoring clinical trial NCT01850524?
This trial is sponsored by Millennium Pharmaceuticals, which has 135 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01850524's enrollment target sits among peer trials
705 505th of 2000 higher than 1,495 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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