Clinical trial NCT00128921
Conditions: Multiple Myeloma
Keywords: Multiple Myeloma
Sponsor: University of Arkansas
Start date: 2006-04-01; Completion date: 2008-02-01
Enrollment: 18 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Velcade (bortezomib, PS-341) has recently been approved by the Food and Drug Administration (FDA) for the treatment of multiple myeloma for patients who have received at least one prior therapy. Velcade is a unique compound developed by scientists at Millennium Pharmaceuticals, Inc. Velcade enters cells and affects the way they divide. Cancer cells are particularly sensitive. Velcade interferes with the enzyme "proteasome" which is responsible for allowing cells to divide. When cancer cells cannot divide, they die. Velcade falls into the class of drugs known as "proteasome inhibitors."

Detailed description:
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 bone activation;
* 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.

Arms: arm 1: Treatment: 1.3 mg/m\^2 arm 2: Treatment: 1.0 mg/m\^2 arm 3: Treatment: 0.7 mg/m\^2
Interventions: intervention 1: VELCADE™
Intervention descriptions: intervention 1: Patients will receive two 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. No growth factors or bisphosphonates will be allowed during study treatment. Bone markers will be measured:

Days 1, 4, 8, 11: Pre-dose, post-dose, and every 2-4 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) Other laboratory and radiologic studies will be performed as detailed in the Study Calendar.

Patients will complete the study after two cycles of VELCADE™. However, if a patient continues to receive VELCADE™ as part of his/her treatment for relapsing MM, routine bone markers may be monitored for the duration of VELCADE™ treatment as clinically indicated.

Protocol documents: