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NCT01432600 · ClinicalTrials.gov registry record · Phase 1
Pomalidomide in Combination With High Dose Dexamethasone and Oral Cyclophosphamide
A Phase 1 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Completed
- Registry status
- Phase 1
- Development phase
- 80
- Enrollment target
NCT01432600: Completed Phase 1 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
NCT01432600 is a Phase 1 study that has completed, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 80 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01432600, a Phase 1 study, has completed, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 80 participants
- Enrollment target
Study Summary
The main purpose of this study is to see whether pomalidomide can help people with myeloma. Researchers also want to find out if pomalidomide is safe and tolerable.
Primary Outcome
The maximum tolerated dose of oral weekly cyclophosphamide in milligrams (mg), in combination with pomalidomide and dexamethasone. Dose Escalation of Cyclophosphamide, orallly (PO) days 1, 8, 15 as follows: Level 1: 300 mg; Level 2: 400 mg; Level 3: 500 mg. The period for assessment of Dose Limiting Toxicity (DLT) is the first cycle (28 days). The following toxicities will be considered dose limiting if encountered only in the phase I portion of the study: Febrile neutropenia; Grade 3 or 4 non-h
Interventions
- DRUG Cyclophosphamide
- DRUG Dexamethasone
- DRUG Pomalidomide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2011-11 |
| Est. Completion | 2016-08 |
| Phase | Phase 1 |
What the finished NCT01432600 record still lists
NCT01432600 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% higher).
The record links to 0 conditions, and to 3 interventions - of which Cyclophosphamide is the first listed.
NCT01432600 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01432600 about?
NCT01432600 is a clinical study titled "Pomalidomide in Combination With High Dose Dexamethasone and Oral Cyclophosphamide". The main purpose of this study is to see whether pomalidomide can help people with myeloma. Researchers also want to find out if pomalidomide is safe and tolerable.
What is the current status of trial NCT01432600?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 80 participants. The study started on 2011-11. Estimated completion is 2016-08.
What interventions are being tested in trial NCT01432600?
The interventions under investigation include: Cyclophosphamide (DRUG), Dexamethasone (DRUG), Pomalidomide (DRUG).
Who is sponsoring clinical trial NCT01432600?
This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01432600's enrollment target sits among peer trials
80 672nd of 2000 higher than 1,305 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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