Combination Chemotherapy and Thalidomide in Treating Patients With Stage I, Stage II, or Stage III Multiple Myeloma
|ClinicalTrials.gov Identifier: NCT00054158|
Recruitment Status : Completed
First Posted : February 6, 2003
Last Update Posted : January 31, 2013
RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. Combining chemotherapy with thalidomide may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and thalidomide in treating patients who have newly diagnosed stage I, stage II, or stage III multiple myeloma.
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma and Plasma Cell Neoplasm||Drug: dexamethasone Drug: doxorubicin hydrochloride Drug: thalidomide Drug: vincristine sulfate||Phase 2|
- Determine the overall response rate in patients with newly diagnosed stage I, II, or III multiple myeloma treated with vincristine, doxorubicin, dexamethasone, and low-dose thalidomide.
- Determine the ability to collect peripheral blood stem cells in patients after treatment with this regimen.
OUTLINE: This is an open-label, nonrandomized study.
Patients receive vincristine IV and doxorubicin IV continuously on days 1-4 and oral dexamethasone on days 1-4, 9-12, and 17-20. Patients also receive low-dose oral thalidomide daily on days 1-28. Treatment repeats every 4 weeks for 4-6 courses in the absence of disease progression.
Patients are followed until disease progression or bone marrow transplantation.
PROJECTED ACCRUAL: Approximately 17-37 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of VAD (Vincristine, Adriamycin, Dexamethasone) Plus Thalidomide (Low Dose) as Frontline Therapy for Newly Diagnosed Patients With Multiple Myeloma (MM)|
|Study Start Date :||August 2004|
|Primary Completion Date :||April 2006|
U.S. FDA Resources
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00054158
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263-0001|
|Study Chair:||Asher A. Chanan-Khan, MD||Roswell Park Cancer Institute|