Combination Chemotherapy in Treating Patients With Stage II or Stage III Multiple Myeloma

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which combination chemotherapy regimen is more effective for multiple myeloma. PURPOSE: This randomized phase III trial is comparing two combination chemotherapy regimens to see how well they work in treating patients with stage II or stage III multiple myeloma.

Detailed Description
-----------------
OBJECTIVES: Compare the partial and complete response rates in patients with multiple myeloma treated with induction therapy comprising idarubicin and dexamethasone vs vincristine, doxorubicin, and dexamethasone. Compare the disease progression, time to achieve maximal response, and duration of response in patients treated with these 2 regimens. Compare the quality of life of patients treated with these 2 regimens. OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive oral idarubicin and oral dexamethasone daily on days 1-4. Treatment continues every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients also receive oral dexamethasone daily on days 8-11 during course 1 only. Arm II: Patients receive oral dexamethasone daily, doxorubicin IV continuously, and vincristine IV continuously on days 1-4. Courses repeat as in arm I. Patients receive additional dexamethasone as in arm I. Patients without a maximal response after completion of course 4 may receive up to 2 additional courses. Quality of life is assessed at baseline and then prior to each study course. Patients are followed for survival. PROJECTED ACCRUAL: A total of 200 patients (100 per arm) will be accrued for this study within 2 years.

Official Title
-----------------
A Randomized Trial Comparing Z-Dex With VAD as Induction Therapy for Patients With Multiple Myeloma

Conditions
-----------------
Multiple Myeloma and Plasma Cell Neoplasm

Intervention / Treatment
-----------------
* Drug: dexamethasone
* Drug: doxorubicin hydrochloride
* Drug: idarubicin
* Drug: vincristine sulfate


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Diagnosis of stage II or III multiple myeloma No prior therapy except local radiotherapy to bone lesions No indolent multiple myeloma No monoclonal gammopathy of unknown significance PATIENT CHARACTERISTICS: Age: 75 and under Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 2.34 mg/dL Renal: No end stage renal failure (creatinine greater than 5.65 mg/dL after rehydration) No requirement for dialysis Other: No other medical condition that would preclude intensive treatment Not pregnant or nursing Fertile patients must use effective contraception No other prior malignancy PRIOR CONCURRENT THERAPY: Biologic therapy See Disease Characteristics Chemotherapy See Disease Characteristics Endocrine therapy See Disease Characteristics Radiotherapy Concurrent local radiotherapy allowed for painful lesions or lesions that appear likely to lead to an imminent fracture Surgery See Disease Characteristics

Ages Eligible for Study
-----------------
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: dexamethasone|nan|
|Drug: doxorubicin hydrochloride|nan|
|Drug: idarubicin|nan|
|Drug: vincristine sulfate|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of response rates |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to achieve a maximal response |  |  | 
| Duration of response |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stage II multiple myeloma, stage III multiple myeloma