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 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.
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.
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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Bone Effect of Bortezomib in Patients With Relapsed/Refractory Multiple Myeloma|
- Maximum Percent Change From Baseline in Intact Parathyroid Hormone Levels on Day 1 [ Time Frame: Baseline and Day 1 ] [ Designated as safety issue: No ]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.
|Study Start Date:||January 2010|
|Study Completion Date:||August 2013|
|Primary Completion Date:||August 2013 (Final data collection date for primary outcome measure)|
Experimental: All patients
All participants enrolled.
Drug: Bortezomib (Velcade)
Bortezomib will be administered as a 3-5 second bolus IV injection at the dose of 0.7 mg/m2 on days 1, 4, 8, and 11 q. 21 days times three cycles.
Patients will undergo three 21-day cycles.
Other Name: Velcade
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01062230
|United States, Utah|
|University of Utah|
|Salt Lake City, Utah, United States, 84112|
|Principal Investigator:||Maurizio Zangari, MD||University of Arkansas|