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NCT01677858 · ClinicalTrials.gov registry record · Phase 1
A Study of Weekly Carfilzomib in Combination With Dexamethasone for Progressive Multiple Myeloma
A Phase 1 study, sponsored by Amgen.
- Completed
- Registry status
- Phase 1
- Development phase
- 116
- Enrollment target
NCT01677858: Completed Phase 1 study, sponsored by Amgen.
NCT01677858 is a Phase 1 study that has completed, run by Amgen. The registered enrollment target is 116 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (93% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01677858, a Phase 1 study, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 116 participants
- Enrollment target
Study Summary
The study had the following primary objectives: * Phase 1: to determine the maximum tolerated dose (MTD) of once-weekly (QW) carfilzomib and dexamethasone for patients with relapsed or refractory multiple myeloma who have received 1 to 3 prior therapies * Phase 2: to estimate the overall response rate (ORR) for patients with relapsed or refractory multiple myeloma who received 1 to 3 prior therapies treated with carfilzomib and dexamethasone QW at the MTD established in phase 1.
Primary Outcome
The MTD was defined as the highest carfilzomib dose at which \< 33% of participants had a treatment-related DLT during the first 28-day cycle. A DLT was categorized as nonhematologic or hematologic and defined as follows: Nonhematologic: * ≥ grade 3 nonhematological toxicity (excluding nausea, vomiting, diarrhea, fatigue lasting \< 14 days, increased serum creatinine or electrolyte abnormalities not clinically significant or requiring treatment) * ≥ grade 3 acute kidney injury (creatinine \> 3
Interventions
- DRUG Dexamethasone
- DRUG Carfilzomib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 116 participants |
| Start Date | 2012-07-04 |
| Est. Completion | 2018-10-31 |
| Phase | Phase 1 |
What the finished NCT01677858 record still lists
NCT01677858 is an interventional study that assigns participants to a tested intervention. The registered 116 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (93% higher).
The record links to 0 conditions, and to 2 interventions - of which Dexamethasone is the first listed.
NCT01677858 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01677858 about?
NCT01677858 is a clinical study titled "A Study of Weekly Carfilzomib in Combination With Dexamethasone for Progressive Multiple Myeloma". The study had the following primary objectives: * Phase 1: to determine the maximum tolerated dose (MTD) of once-weekly (QW) carfilzomib and dexamethasone for patients with relapsed or refractory multiple myeloma who have received 1 to 3 prior therapies * Phase 2: to estimate the overall response r...
What is the current status of trial NCT01677858?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 116 participants. The study started on 2012-07-04. Estimated completion is 2018-10-31.
What interventions are being tested in trial NCT01677858?
The interventions under investigation include: Dexamethasone (DRUG), Carfilzomib (DRUG).
Who is sponsoring clinical trial NCT01677858?
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 NCT01677858's enrollment target sits among peer trials
116 501st of 2000 higher than 1,497 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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