A Phase II Dose-Response Study of Velcade® and Bone Formation in Patients With Relapsed/Refractory Multiple Myeloma
Studies at the Myeloma Institute for Research & Therapy have shown that Velcade is very
effective in treating patients who are relapsing after having been treated with at least two
lines of prior therapy.
One key factor in multiple myeloma is bone destruction caused by the myeloma cells. Most
patients with multiple myeloma (80%) will develop skeletal lesions, despite treatment.
These lesions are rarely repaired, even when the myeloma is in remission.
Experience at MIRT has suggested that Velcade may increase osteoblast (bone cells that cause
bone growth) activity. One goal of this study is to identify if Velcade's effect on myeloma
is due to its ability to increase osteoblasts.
This study also has the following goals:
- To find out the lowest dose of Velcade that has an effect on myeloma and also increases
- To identify ways to predict if Velcade will increase bone activation.
Time periods are:
According to cohort assignment, you will receive three cycles of Velcade®™ (1.3 mg/m2, 1.0
mg/m2 or 0.7 mg/m2) on days 1, 4, 8, and 11, on a 21-day cycle.
During the first two cycles of Velcade®™, bone markers (tests on your bones) will be
measured Days 1, 4, 8, 11: Pre-dose, post-dose, and every 2 to 4 hours for 8 hours.
Days 2-3, 5-7, 9-10, 12-21: every 24 hours, beginning with the immediate post-dose sample
(+/- 2 hours)
During the third cycle of Velcade®™, bone markers will be measured Days 1 and 11: Pre-dose
and post-dose, and then again on Day 21.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Number of Participants With a Positive Response to Bortezomib Measured by the Bone Marker Parathyroid Hormone
Parathyroid hormone: Any increase in PTH was considered response
Maurizio Zangari, MD
University of Arkansas
United States: Institutional Review Board
|University of Arkansas for Medical Sciences||Little Rock, Arkansas 72205|