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NCT01080391 · ClinicalTrials.gov registry record · Phase 3
Study Comparing Carfilzomib, Lenalidomide, and Dexamethasone (CRd) vs Lenalidomide and Dexamethasone (Rd) in Subjects With Relapsed Multiple Myeloma
A Phase 3 study, sponsored by Amgen.
- Completed
- Registry status
- Phase 3
- Development phase
- 792
- Enrollment target
NCT01080391: Completed Phase 3 study, sponsored by Amgen.
NCT01080391 is a Phase 3 study that has completed, run by Amgen. The registered enrollment target is 792 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
NCT01080391, a Phase 3 study, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 792 participants
- Enrollment target
Study Summary
The primary objective was to compare progression-free survival in adults with relapsed multiple myeloma who are receiving CRd vs participants receiving Rd in a randomized multicenter setting.
Primary Outcome
Kaplan-Meier estimate of median time from randomization to progressive disease (PD) or all-cause death. PD was assessed using International Myeloma Working Group-Uniform Response Criteria (IMWG-URC). One or more conditions were required to meet PD: 2 consecutive rising serum or urine M-protein from central lab; documented new bone lesion(s) or soft tissue plasmacytoma(s) or increased size of existing bone lesion(s) or plasmacytoma(s); or confirmed hypercalcemia due solely to plasma cell prolifer
Interventions
- DRUG Dexamethasone
- DRUG Lenalidomide
- DRUG Carfilzomib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 792 participants |
| Start Date | 2010-07-14 |
| Est. Completion | 2017-12-05 |
| Phase | Phase 3 |
What the finished NCT01080391 record still lists
NCT01080391 is an interventional study that assigns participants to a tested intervention. The registered 792 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 3 interventions - of which Dexamethasone is the first listed.
NCT01080391 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01080391 about?
NCT01080391 is a clinical study titled "Study Comparing Carfilzomib, Lenalidomide, and Dexamethasone (CRd) vs Lenalidomide and Dexamethasone (Rd) in Subjects With Relapsed Multiple Myeloma". The primary objective was to compare progression-free survival in adults with relapsed multiple myeloma who are receiving CRd vs participants receiving Rd in a randomized multicenter setting.
What is the current status of trial NCT01080391?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 792 participants. The study started on 2010-07-14. Estimated completion is 2017-12-05.
What interventions are being tested in trial NCT01080391?
The interventions under investigation include: Dexamethasone (DRUG), Lenalidomide (DRUG), Carfilzomib (DRUG).
Who is sponsoring clinical trial NCT01080391?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01080391's enrollment target sits among peer trials
792 429th of 2000 higher than 1,572 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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