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NCT02181413 · ClinicalTrials.gov registry record · Phase 3
A Study of Oral Ixazomib Citrate (MLN9708) Maintenance Therapy in Participants With Multiple Myeloma Following Autologous Stem Cell Transplant
A Phase 3 study, sponsored by Takeda.
- Completed
- Registry status
- Phase 3
- Development phase
- 656
- Enrollment target
NCT02181413: Completed Phase 3 study, sponsored by Takeda.
NCT02181413 is a Phase 3 study that has completed, run by Takeda. The registered enrollment target is 656 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (15% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02181413, a Phase 3 study, has completed, sponsored by Takeda.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 656 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the effect of ixazomib citrate maintenance therapy on progression-free survival (PFS), compared to placebo, in participants with newly diagnosed multiple myeloma (NDMM) who have had a response (complete response \[CR\], very good partial response \[VGPR\], or partial response \[PR\]) to induction therapy followed by high-dose therapy (HDT) and autologous stem cell transplant (ASCT).
Primary Outcome
PFS was defined as the time from the date of randomization to the date of first documentation of PD, as evaluated by an independent review committee (IRC) according to International Myeloma Working Group (IMWG) criteria, or death due to any cause, whichever occurred first. PD was defined as ≥25% increase from lowest value in: serum/urine M component; participants without measurable serum and urine M-protein levels, the difference between involved and uninvolved free light chain (FLC) levels must
Interventions
- DRUG Placebo
- DRUG Ixazomib Citrate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 656 participants |
| Start Date | 2014-07-16 |
| Est. Completion | 2023-09-08 |
| Phase | Phase 3 |
What the finished NCT02181413 record still lists
NCT02181413 is an interventional study that assigns participants to a tested intervention. The registered 656 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (15% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02181413 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02181413 about?
NCT02181413 is a clinical study titled "A Study of Oral Ixazomib Citrate (MLN9708) Maintenance Therapy in Participants With Multiple Myeloma Following Autologous Stem Cell Transplant". The purpose of this study is to determine the effect of ixazomib citrate maintenance therapy on progression-free survival (PFS), compared to placebo, in participants with newly diagnosed multiple myeloma (NDMM) who have had a response (complete response \[CR\], very good partial response \[VGPR\], o...
What is the current status of trial NCT02181413?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 656 participants. The study started on 2014-07-16. Estimated completion is 2023-09-08.
What interventions are being tested in trial NCT02181413?
The interventions under investigation include: Placebo (DRUG), Ixazomib Citrate (DRUG).
Who is sponsoring clinical trial NCT02181413?
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 NCT02181413's enrollment target sits among peer trials
656 565th of 2000 higher than 1,436 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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