Combination Chemotherapy in Treating Patients With Multiple Myeloma
|ClinicalTrials.gov Identifier: NCT00003493|
Recruitment Status : Completed
First Posted : April 14, 2004
Last Update Posted : July 18, 2013
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy consisting of liposomal doxorubicin, vincristine, and dexamethasone in treating patients with newly diagnosed or previously treated multiple myeloma.
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma and Plasma Cell Neoplasm||Drug: dexamethasone Drug: pegylated liposomal doxorubicin hydrochloride Drug: vincristine sulfate||Phase 2|
OBJECTIVES: I. Assess the response rate and duration of response of multiple myeloma treated with doxorubicin HCl liposome, vincristine, and dexamethasone. II. Define the qualitative and quantitative toxic effects of this regimen in these patients.
OUTLINE: Patients are stratified into newly diagnosed (group A) and previously treated (group B) patients. Patients receive doxorubicin HCl liposome IV over 2.5 hours, followed by vincristine by bolus IV over 5 minutes on day 1. Dexamethasone is administered orally or by IV on days 1-4. Treatment is repeated every 4 weeks for a minimum of 6 courses, and 2 courses after maximum response unless unacceptable toxic effects or disease progression occur. Patients are followed until death.
PROJECTED ACCRUAL: A maximum of 33 patients from group A and 34 patients from group B will be accrued for this study within 6-14 months.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Phase II Trial of Doxil, Vincristine and Decadron in Multiple Myeloma|
|Study Start Date :||November 1998|
|Study Completion Date :||April 2004|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003493
|United States, Ohio|
|Cleveland Clinic Taussig Cancer Center|
|Cleveland, Ohio, United States, 44195|
|Study Chair:||Mohamad A. Hussein, MD||The Cleveland Clinic|