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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 is a Phase 2 study that was terminated before completion, run by University of Arkansas. The registered enrollment target is 6 participants.
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.
Interventions
- DRUG Bortezomib (Velcade)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2010-01 |
| Est. Completion | 2013-08 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01062230
The ClinicalTrials.gov registry entry for NCT01062230 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Arkansas, which has 318 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Bortezomib (Velcade) is the first listed.
NCT01062230 reports 0 study locations.
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.
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