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NCT01564537 · ClinicalTrials.gov registry record · Phase 3
A Phase 3 Study Comparing Oral Ixazomib Plus Lenalidomide and Dexamethasone Versus Placebo Plus Lenalidomide and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma
A Phase 3 study, sponsored by Takeda.
- Completed
- Registry status
- Phase 3
- Development phase
- 722
- Enrollment target
NCT01564537: Completed Phase 3 study, sponsored by Takeda.
NCT01564537 is a Phase 3 study that has completed, run by Takeda. The registered enrollment target is 722 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
NCT01564537, a Phase 3 study, has completed, sponsored by Takeda.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 722 participants
- Enrollment target
Study Summary
The purpose of this study is to determine whether the addition of oral ixazomib to the background therapy of lenalidomide and dexamethasone improves progression free survival (PFS) in participants with relapsed and/or refractory multiple myeloma (RRMM).
Primary Outcome
Progression Free Survival (PFS) is defined as the time from the date of randomization to the date of first documentation of disease progression (PD) or death due to any cause, whichever occurs first. Response including PD was assessed by independent review committee (IRC) using the International Myeloma Working Group (IMWG) response criteria. PD requires 1 of the following: Increase of ≥ 25% from nadir in: Serum M-component (absolute increase ≥ 0.5 g/dl); Urine M-component (absolute increase ≥ 2
Interventions
- DRUG Placebo
- DRUG Dexamethasone
- DRUG Lenalidomide
- DRUG Ixazomib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 722 participants |
| Start Date | 2012-08-01 |
| Est. Completion | 2022-02-08 |
| Phase | Phase 3 |
What the finished NCT01564537 record still lists
NCT01564537 is an interventional study that assigns participants to a tested intervention. The registered 722 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.
NCT01564537 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01564537 about?
NCT01564537 is a clinical study titled "A Phase 3 Study Comparing Oral Ixazomib Plus Lenalidomide and Dexamethasone Versus Placebo Plus Lenalidomide and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma". The purpose of this study is to determine whether the addition of oral ixazomib to the background therapy of lenalidomide and dexamethasone improves progression free survival (PFS) in participants with relapsed and/or refractory multiple myeloma (RRMM).
What is the current status of trial NCT01564537?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 722 participants. The study started on 2012-08-01. Estimated completion is 2022-02-08.
What interventions are being tested in trial NCT01564537?
The interventions under investigation include: Placebo (DRUG), Dexamethasone (DRUG), Lenalidomide (DRUG), Ixazomib (DRUG).
Who is sponsoring clinical trial NCT01564537?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01564537's enrollment target sits among peer trials
722 494th of 2000 higher than 1,507 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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