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NCT02312258 · ClinicalTrials.gov registry record · Phase 3
A Study of Oral Ixazomib Maintenance Therapy in Participants With Newly Diagnosed Multiple Myeloma (NDMM) Not Treated With Stem Cell Transplantation (SCT)
A Phase 3 study, sponsored by Takeda.
- Completed
- Registry status
- Phase 3
- Development phase
- 706
- Enrollment target
NCT02312258: Completed Phase 3 study, sponsored by Takeda.
NCT02312258 is a Phase 3 study that has completed, run by Takeda. The registered enrollment target is 706 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
NCT02312258, a Phase 3 study, has completed, sponsored by Takeda.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 706 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the effect of ixazomib maintenance therapy on progression free survival (PFS) compared with placebo, in participants with NDMM who have had a major response (complete response \[CR\], very good partial response \[VGPR\], or partial response \[PR\]) to initial therapy and who have not undergone SCT.
Primary Outcome
PFS is defined as the time from the date of randomization to the date of first documentation of progressive disease (PD) or death from any cause, as evaluated by an independent review committee (IRC) according to International Myeloma Working Group (IMWG) criteria, or death due to any cause, whichever occurs first. Per IMWG criteria, PD is defined as, increase of 25% of lowest response value in one or more of following criteria: serum M-component (absolute increase ≥0.5 g/ deciliter (dL)); or ur
Interventions
- DRUG Placebo
- DRUG Ixazomib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 706 participants |
| Start Date | 2015-04-09 |
| Est. Completion | 2022-08-26 |
| Phase | Phase 3 |
What the finished NCT02312258 record still lists
NCT02312258 is an interventional study that assigns participants to a tested intervention. The registered 706 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 2 interventions - of which Placebo is the first listed.
NCT02312258 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02312258 about?
NCT02312258 is a clinical study titled "A Study of Oral Ixazomib Maintenance Therapy in Participants With Newly Diagnosed Multiple Myeloma (NDMM) Not Treated With Stem Cell Transplantation (SCT)". The purpose of this study is to determine the effect of ixazomib maintenance therapy on progression free survival (PFS) compared with placebo, in participants with NDMM who have had a major response (complete response \[CR\], very good partial response \[VGPR\], or partial response \[PR\]) to initia...
What is the current status of trial NCT02312258?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 706 participants. The study started on 2015-04-09. Estimated completion is 2022-08-26.
What interventions are being tested in trial NCT02312258?
The interventions under investigation include: Placebo (DRUG), Ixazomib (DRUG).
Who is sponsoring clinical trial NCT02312258?
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 NCT02312258's enrollment target sits among peer trials
706 505th of 2000 higher than 1,496 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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