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NCT01659658 · ClinicalTrials.gov registry record · Phase 3
Study of Dexamethasone Plus IXAZOMIB (MLN9708) or Physicians Choice of Treatment in Relapsed or Refractory Systemic Light Chain (AL) Amyloidosis
A Phase 3 study, sponsored by Millennium Pharmaceuticals.
- Terminated
- Registry status
- Phase 3
- Development phase
- 177
- Enrollment target
NCT01659658: Clinical Trial Phase 3 study, sponsored by Millennium Pharmaceuticals.
NCT01659658 is a Phase 3 study that was terminated before completion, run by Millennium Pharmaceuticals. The registered enrollment target is 177 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01659658, a Phase 3 study, was terminated before completion, sponsored by Millennium Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 177 participants
- Enrollment target
Study Summary
The purpose of this study is to provide continued access of ixazomib and/or other study medications and to continue collecting relevant safety data to monitor participant's safety, determine whether dexamethasone plus IXAZOMIB improves hematologic response, 2-year vital organ (that is, heart or kidney) deterioration and mortality rate versus a physician's choice of a chemotherapy regimen in participants diagnosed with relapsed or refractory systemic light chain (AL) amyloidosis.
Primary Outcome
Overall hematologic response was defined as the percentage of participants with complete response (CR), very good partial response (VGPR) and partial response (PR) based on central laboratory results and the 2010 International Society of Amyloidosis (ISA) Consensus Criteria as assessed by an adjudication committee. CR: Complete disappearance of M-protein from serum and urine on immunofixation, and normalization of free light chain (FLC) ratio. VGPR: differential free light chain (difference betw
Interventions
- DRUG Cyclophosphamide
- DRUG Melphalan
- DRUG Dexamethasone
- DRUG Thalidomide
- DRUG IXAZOMIB
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 177 participants |
| Start Date | 2012-12-26 |
| Est. Completion | 2022-07-11 |
| Phase | Phase 3 |
Why NCT01659658 stopped before completion
NCT01659658 is an interventional study that assigns participants to a tested intervention. The registered 177 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 (77% lower).
The record links to 0 conditions, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT01659658 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01659658 about?
NCT01659658 is a clinical study titled "Study of Dexamethasone Plus IXAZOMIB (MLN9708) or Physicians Choice of Treatment in Relapsed or Refractory Systemic Light Chain (AL) Amyloidosis". The purpose of this study is to provide continued access of ixazomib and/or other study medications and to continue collecting relevant safety data to monitor participant's safety, determine whether dexamethasone plus IXAZOMIB improves hematologic response, 2-year vital organ (that is, heart or kidn...
What is the current status of trial NCT01659658?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 177 participants. The study started on 2012-12-26. Estimated completion is 2022-07-11.
What interventions are being tested in trial NCT01659658?
The interventions under investigation include: Cyclophosphamide (DRUG), Melphalan (DRUG), Dexamethasone (DRUG), Thalidomide (DRUG), IXAZOMIB (DRUG).
Who is sponsoring clinical trial NCT01659658?
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 NCT01659658's enrollment target sits among peer trials
177 1438th of 2000 higher than 563 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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