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NCT00891033 · ClinicalTrials.gov registry record · Phase 1
Panobinostat/Velcade in Multiple Myeloma
A Phase 1 study, sponsored by University of Arkansas.
- Terminated
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT00891033: Clinical Trial Phase 1 study, sponsored by University of Arkansas.
NCT00891033 is a Phase 1 study that was terminated before completion, run by University of Arkansas. The registered enrollment target is 12 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00891033, a Phase 1 study, was terminated before completion, sponsored by University of Arkansas.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
Multiple myeloma (MM) accounts for approximately 1% of all malignancies and 10% of hematological tumors, representing the second most frequently occurring hematological malignancy in the United States. At any one time, 50,000 people suffer from MM, and approximately 15,000 are diagnosed each year. The median age is approximately 65 years, although occasionally MM occurs in the second decade of life. Bortezomib and panobinostat intravenous (IV) are active agents in multiple myeloma and appear to work through different biochemical pathways, suggesting that there may be a synergistic effect using the combination. Both compounds have shown anabolic bone effect, which has been associated to significant anti-myeloma activity. Primary objectives: * To assess the toxicity of bortezomib combined with one of 4 doses of panobinostat IV in patients with relapsed/refractory multiple myeloma, and * To find the most appropriate doses of bortezomib and panobinostat IV in the combination. Secondary objective: * To assess the effect of bortezomib in combination with panobinostat IV on inducing osteoblast activation in patients with relapsed/refractory myeloma.
Primary Outcome
DLT is defined as at least 2 of 6 patients within a group experiencing greater than or equal to grade 3 non-hematologic toxicity or greater than or equal to grade 4 hematologic toxicity.
Interventions
- DRUG Panobinostat
- DRUG Bortezomib (Velcade)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2009-04 |
| Est. Completion | 2013-08 |
| Phase | Phase 1 |
Why NCT00891033 stopped before completion
NCT00891033 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 2 interventions - of which Panobinostat is the first listed.
NCT00891033 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00891033 about?
NCT00891033 is a clinical study titled "Panobinostat/Velcade in Multiple Myeloma". Multiple myeloma (MM) accounts for approximately 1% of all malignancies and 10% of hematological tumors, representing the second most frequently occurring hematological malignancy in the United States. At any one time, 50,000 people suffer from MM, and approximately 15,000 are diagnosed each year. T...
What is the current status of trial NCT00891033?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2009-04. Estimated completion is 2013-08.
What interventions are being tested in trial NCT00891033?
The interventions under investigation include: Panobinostat (DRUG), Bortezomib (Velcade) (DRUG).
Who is sponsoring clinical trial NCT00891033?
This trial is sponsored by University of Arkansas, which has 318 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00891033's enrollment target sits among peer trials
12 1852nd of 2000 higher than 90 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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