A Phase II Trial With VELCADE® (PS-341), Cytoxan (Cyclophosphamide), Dexamethasone and Thalomid® (VEL-CTD) in Previously Untreated Multiple Myeloma Patients
OBJECTIVES:
Primary
- Determine the response rate in patients with newly diagnosed, previously untreated
multiple myeloma treated with bortezomib, cyclophosphamide, dexamethasone, and
thalidomide.
Secondary
- Determine the safety and tolerability of this regimen in these patients.
OUTLINE: This is an open-label, multicenter study.
Patients receive bortezomib IV on days 1, 4, 8, and 11; cyclophosphamide IV on days 1 and 8
of courses 1-3; oral thalidomide once daily on days 1-21 beginning in course 4; and
dexamethasone IV or orally once daily on days 1, 2, 4, 5, 8, 9, 11, and 12. Treatment
repeats every 21 days for up to 6 courses in the absence of disease progression or
unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 43 patients will be accrued for this study.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Response rate
No
William I. Bensinger, MD
Principal Investigator
Fred Hutchinson Cancer Research Center
United States: Federal Government
CDR0000536219
NCT00438841
August 2006
Name | Location |
---|---|
Fred Hutchinson Cancer Research Center | Seattle, Washington 98109 |
Sutter Cancer Center | Sacramento, California 95816 |
St. Vincent's Comprehensive Cancer Center - Manhattan | New York, New York 10011 |
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center | Los Angeles, California 90048-1865 |
Alta Bates Summit Comprehensive Cancer Center | Berkeley, California 94704 |
Seattle Cancer Care Alliance | Seattle, Washington 98109 |
Desert Regional Medical Center Comprehensive Cancer Center | Palm Springs, California 92262 |
Oregon Health and Science University Cancer Institute | Portland, Oregon 97239-3098 |
Eugene M. and Christine E. Lynn Cancer Institute at Boca Raton Community Hospital - Main Campus | Boca Raton, Florida 33486 |
Lone Star Oncology - Austin | Austin, Texas 78759 |