MedTrace Logo

Study of Velcade® and Bone Formation in Patients With Relapsed/Refractory Multiple Myeloma

NCT00128921 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2012-04-26

Study results available
· View outcomes & findings →

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."

Conditions

Interventions

DRUG

VELCADE™

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.

Sponsors & Collaborators

  • University of Arkansas

    lead OTHER

Principal Investigators

  • Maurizio Zangari, MD · University of Arkansas

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-04-30
Primary Completion
2008-02-29
Completion
2008-02-29

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00128921 on ClinicalTrials.gov