Bortezomib, Cyclophosphamide, Dexamethasone, and Thalidomide in Treating Patients With Newly Diagnosed, Previously Untreated Multiple Myeloma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00438841|
Recruitment Status : Unknown
Verified March 2009 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : February 22, 2007
Last Update Posted : March 13, 2009
RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cyclophosphamide and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Thalidomide may stop the growth of cancer cells by blocking blood flow to the cancer. Giving bortezomib together with cyclophosphamide, dexamethasone, and thalidomide may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving bortezomib together with cyclophosphamide, dexamethasone, and thalidomide works in treating patients with newly diagnosed, previously untreated multiple myeloma.
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma and Plasma Cell Neoplasm||Drug: bortezomib Drug: cyclophosphamide Drug: dexamethasone Drug: thalidomide||Phase 2|
- Determine the response rate in patients with newly diagnosed, previously untreated multiple myeloma treated with bortezomib, cyclophosphamide, dexamethasone, and thalidomide.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||43 participants|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial With VELCADE® (PS-341), Cytoxan (Cyclophosphamide), Dexamethasone and Thalomid® (VEL-CTD) in Previously Untreated Multiple Myeloma Patients|
|Study Start Date :||August 2006|
|Estimated Primary Completion Date :||December 2008|
U.S. FDA Resources
- Response rate
- Safety and tolerability
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00438841
|United States, California|
|Alta Bates Summit Comprehensive Cancer Center|
|Berkeley, California, United States, 94704|
|Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center|
|Los Angeles, California, United States, 90048|
|Desert Regional Medical Center Comprehensive Cancer Center|
|Palm Springs, California, United States, 92262|
|Sutter Cancer Center|
|Sacramento, California, United States, 95816|
|United States, Florida|
|Eugene M. and Christine E. Lynn Cancer Institute at Boca Raton Community Hospital - Main Campus|
|Boca Raton, Florida, United States, 33486|
|United States, New York|
|St. Vincent's Comprehensive Cancer Center - Manhattan|
|New York, New York, United States, 10011|
|United States, Oregon|
|Oregon Health and Science University Cancer Institute|
|Portland, Oregon, United States, 97239|
|United States, Texas|
|Lone Star Oncology - Austin|
|Austin, Texas, United States, 78759|
|United States, Washington|
|Seattle Cancer Care Alliance|
|Seattle, Washington, United States, 98109-1023|
|Fred Hutchinson Cancer Research Center|
|Seattle, Washington, United States, 98109-1024|
|Principal Investigator:||William I. Bensinger, MD||Fred Hutchinson Cancer Research Center|