Bone Effect of Bortezomib in Patients With Relapsed/Refractory Multiple Myeloma
Status:
Terminated
Trial end date:
2013-08-01
Target enrollment:
Participant gender:
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.