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NCT01999335 · ClinicalTrials.gov registry record · Phase 1
A Study of Oprozomib, Pomalidomide, and Dexamethasone in Adults With Primary Refractory or Relapsed and Refractory Multiple Myeloma
A Phase 1 study, sponsored by Amgen.
- Terminated
- Registry status
- Phase 1
- Development phase
- 33
- Enrollment target
NCT01999335: Clinical Trial Phase 1 study, sponsored by Amgen.
NCT01999335 is a Phase 1 study that was terminated before completion, run by Amgen. The registered enrollment target is 33 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (45% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01999335, a Phase 1 study, was terminated before completion, sponsored by Amgen.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 33 participants
- Enrollment target
Study Summary
The purpose of the Phase 1 part of the study is to determine the maximum tolerated dose and assess the safety, tolerability and activity of oprozomib in combination with pomalidomide and dexamethasone in adults with primary refractory or relapsed and refractory multiple myeloma. The purpose of the Phase 3 part of the study is to compare the efficacy for adults with primary refractory or relapsed and refractory multiple myeloma who are randomized to either oprozomib or placebo in combination with pomalidomide and dexamethasone.
Primary Outcome
DLTs were assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03, defined as any of the following treatment-related events occurring within 4 weeks after the first dose of therapy: Any grade ≥ 3 nonhematologic toxicity, except: Grade 3 asymptomatic electrolyte abnormalities or hypophosphatemia for \< 24 hours; Grade 3 nausea, vomiting or diarrhea unless for \> 3 days despite optimal supportive care; Grade 3 fatigue for \< 14 days; Grade ≥
Interventions
- DRUG Dexamethasone
- DRUG Pomalidomide
- DRUG Oprozomib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2014-07-30 |
| Est. Completion | 2019-04-25 |
| Phase | Phase 1 |
Why NCT01999335 stopped before completion
NCT01999335 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (45% lower).
The record links to 0 conditions, and to 3 interventions - of which Dexamethasone is the first listed.
NCT01999335 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01999335 about?
NCT01999335 is a clinical study titled "A Study of Oprozomib, Pomalidomide, and Dexamethasone in Adults With Primary Refractory or Relapsed and Refractory Multiple Myeloma". The purpose of the Phase 1 part of the study is to determine the maximum tolerated dose and assess the safety, tolerability and activity of oprozomib in combination with pomalidomide and dexamethasone in adults with primary refractory or relapsed and refractory multiple myeloma. The purpose of the ...
What is the current status of trial NCT01999335?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 33 participants. The study started on 2014-07-30. Estimated completion is 2019-04-25.
What interventions are being tested in trial NCT01999335?
The interventions under investigation include: Dexamethasone (DRUG), Pomalidomide (DRUG), Oprozomib (DRUG).
Who is sponsoring clinical trial NCT01999335?
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 NCT01999335's enrollment target sits among peer trials
33 1280th of 2000 higher than 705 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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