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NCT03859427 · ClinicalTrials.gov registry record · Phase 3
A Study Comparing Once-weekly vs Twice-weekly Carfilzomib in Combination With Lenalidomide and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma
A Phase 3 study, sponsored by Amgen.
- Completed
- Registry status
- Phase 3
- Development phase
- 454
- Enrollment target
NCT03859427: Completed Phase 3 study, sponsored by Amgen.
NCT03859427 is a Phase 3 study that has completed, run by Amgen. The registered enrollment target is 454 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (41% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03859427, a Phase 3 study, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 454 participants
- Enrollment target
Study Summary
Compare efficacy of 56 mg/m2 carfilzomib administered once-weekly in combination with lenalidomide and dexamethasone (KRd 56 mg/m2) to 27 mg/m2 carfilzomib administered twice-weekly in combination with lenalidomide and dexamethasone (KRd 27 mg/m2) in subjects with relapsed or refractory multiple myeloma (RRMM) with 1 to 3 prior lines of therapy.
Primary Outcome
ORR was defined as the percentage of participants with a best overall response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) per IMWG-URC. CR: negative immunofixation on serum and urine, soft tissue plasmacytomas disappearance, \< 5% plasma cells in bone marrow (BM). sCR: CR and normal serum free light chain ratio and no clonal cells in BM by immunohistochemistry. VGPR: Serum and urine M-protein detectable by immunofixat
Interventions
- DRUG Dexamethasone
- DRUG Lenalidomide
- DRUG Carfilzomib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 454 participants |
| Start Date | 2019-05-08 |
| Est. Completion | 2023-03-31 |
| Phase | Phase 3 |
What the finished NCT03859427 record still lists
NCT03859427 is an interventional study that assigns participants to a tested intervention. The registered 454 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 (41% lower).
The record links to 0 conditions, and to 3 interventions - of which Dexamethasone is the first listed.
NCT03859427 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03859427 about?
NCT03859427 is a clinical study titled "A Study Comparing Once-weekly vs Twice-weekly Carfilzomib in Combination With Lenalidomide and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma". Compare efficacy of 56 mg/m2 carfilzomib administered once-weekly in combination with lenalidomide and dexamethasone (KRd 56 mg/m2) to 27 mg/m2 carfilzomib administered twice-weekly in combination with lenalidomide and dexamethasone (KRd 27 mg/m2) in subjects with relapsed or refractory multiple mye...
What is the current status of trial NCT03859427?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 454 participants. The study started on 2019-05-08. Estimated completion is 2023-03-31.
What interventions are being tested in trial NCT03859427?
The interventions under investigation include: Dexamethasone (DRUG), Lenalidomide (DRUG), Carfilzomib (DRUG).
Who is sponsoring clinical trial NCT03859427?
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 NCT03859427's enrollment target sits among peer trials
454 831st of 2000 higher than 1,167 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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