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NCT01062230 · ClinicalTrials.gov registry record · Phase 2
Bone Effect of Bortezomib in Patients With Relapsed/Refractory Multiple Myeloma
A Phase 2 study, sponsored by University of Arkansas.
- Terminated
- Registry status
- Phase 2
- Development phase
- 6
- Enrollment target
NCT01062230: Clinical Trial Phase 2 study, sponsored by University of Arkansas.
NCT01062230 is a Phase 2 study that was terminated before completion, run by University of Arkansas. The registered enrollment target is 6 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01062230, a Phase 2 study, was terminated before completion, sponsored by University of Arkansas.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 6 participants
- Enrollment target
Study Summary
The primary aim of this trial is to determine the effect of a short course (i.e., 3 cycles) of low-dose Bortezomib (Velcade) on bone remodeling and on disease progression. The dose of bortezomib used in this trial of 0.7 mg/m2 is the lowest dose which has shown efficacy in the 3 largest monotherapy trials with bortezomib. 17% of patients in the APEX, 9% patients in CREST and 24% in SUMMIT trials were treated with 0.7 mg/m2 dosages. Bortezomib will be given on days 1, 8, 15, 22 over 42 days to reduce the incidence of possible drug related side effects. OBJECTIVES: Primary Objective The primary objective of this study is to: * To evaluate the effect of Velcade at 0.7 mg/m2 dose on inducing osteoblast activation as measured by ALP and other bone markers in patients with relapsed/refractory myeloma. Secondary Objectives The secondary objectives of this study are to: * To evaluate the association between osteoblastic activation and myeloma response to Velcade. * To identify predictive factors for Velcade-associated osteoblastic activation.
Primary Outcome
All patients received 0.7 mg/m2 of bortezomib on days 1, 4, 8 and 11 of a 21 day cycle, for maximum of three cycles for an average of 18 months. Intact Parathyroid hormone was measured in patients with relapsed/refractory myeloma for osteoblast activation. Other bone markers were examined using similar methods.
Interventions
- DRUG Bortezomib (Velcade)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2010-01 |
| Est. Completion | 2013-08 |
| Phase | Phase 2 |
Why NCT01062230 stopped before completion
NCT01062230 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 1 intervention - of which Bortezomib (Velcade) is the first listed.
NCT01062230 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01062230 about?
NCT01062230 is a clinical study titled "Bone Effect of Bortezomib in Patients With Relapsed/Refractory Multiple Myeloma". The primary aim of this trial is to determine the effect of a short course (i.e., 3 cycles) of low-dose Bortezomib (Velcade) on bone remodeling and on disease progression. The dose of bortezomib used in this trial of 0.7 mg/m2 is the lowest dose which has shown efficacy in the 3 largest monotherapy ...
What is the current status of trial NCT01062230?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 6 participants. The study started on 2010-01. Estimated completion is 2013-08.
What interventions are being tested in trial NCT01062230?
The interventions under investigation include: Bortezomib (Velcade) (DRUG).
Who is sponsoring clinical trial NCT01062230?
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 NCT01062230's enrollment target sits among peer trials
6 1996th of 2000 higher than 1 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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