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NCT00833833 · ClinicalTrials.gov registry record · Phase 1
MTD, Safety, and Efficacy of Pomalidomide (CC-4047) Alone or With Low-dose Dexamethasone in Patients With Relapsed and Refractory Multiple Myeloma
A Phase 1 study, sponsored by Celgene Corporation.
- Completed
- Registry status
- Phase 1
- Development phase
- 259
- Enrollment target
NCT00833833: Completed Phase 1 study, sponsored by Celgene Corporation.
NCT00833833 is a Phase 1 study that has completed, run by Celgene Corporation. The registered enrollment target is 259 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (332% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00833833, a Phase 1 study, has completed, sponsored by Celgene Corporation.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 259 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the maximum tolerated dose and effectiveness of the study drug (CC-4047) Alone Or in Combination With Low-dose Dexamethasone as treatment for patients with relapsed and refractory multiple myeloma
Primary Outcome
The maximum tolerated dose was defined as the highest dose level at which no more than 1 of 6 participants experiences a DLT within the first 28-day cycle. DLTs were defined as: * Grade 4 neutropenia or thrombocytopenia * Febrile neutropenia * Grade 3 or 4 nausea, vomiting or diarrhea despite optimal symptomatic treatment * Serum transaminase \> 20 \* upper limit of normal (ULN) * Serum transaminase \> 5 \* ULN for \>= 7 days * Delay of the start of cycle 2 by \>7 days due to pomalidomide-rela
Interventions
- DRUG Aspirin
- DRUG Dexamethasone
- DRUG Pomalidomide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 259 participants |
| Start Date | 2008-06 |
| Est. Completion | 2015-09 |
| Phase | Phase 1 |
What the finished NCT00833833 record still lists
NCT00833833 is an interventional study that assigns participants to a tested intervention. The registered 259 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 (332% higher).
The record links to 0 conditions, and to 3 interventions - of which Aspirin is the first listed.
NCT00833833 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00833833 about?
NCT00833833 is a clinical study titled "MTD, Safety, and Efficacy of Pomalidomide (CC-4047) Alone or With Low-dose Dexamethasone in Patients With Relapsed and Refractory Multiple Myeloma". The purpose of this study is to determine the maximum tolerated dose and effectiveness of the study drug (CC-4047) Alone Or in Combination With Low-dose Dexamethasone as treatment for patients with relapsed and refractory multiple myeloma
What is the current status of trial NCT00833833?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 259 participants. The study started on 2008-06. Estimated completion is 2015-09.
What interventions are being tested in trial NCT00833833?
The interventions under investigation include: Aspirin (DRUG), Dexamethasone (DRUG), Pomalidomide (DRUG).
Who is sponsoring clinical trial NCT00833833?
This trial is sponsored by Celgene Corporation, which has 40 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00833833's enrollment target sits among peer trials
259 167th of 2000 higher than 1,834 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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