Combination Chemotherapy and Thalidomide in Treating Patients With Stage I, Stage II, or Stage III Multiple Myeloma

Study Overview
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Brief Summary
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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.

Detailed Description
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OBJECTIVES: 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.

Official Title
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A Phase II Study of VAD (Vincristine, Adriamycin, Dexamethasone) Plus Thalidomide (Low Dose) as Frontline Therapy for Newly Diagnosed Patients With Multiple Myeloma (MM)

Conditions
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Multiple Myeloma and Plasma Cell Neoplasm

Intervention / Treatment
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* Drug: dexamethasone
* Drug: doxorubicin hydrochloride
* Drug: thalidomide
* Drug: vincristine sulfate


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Newly diagnosed stage I, II, or III multiple myeloma (MM) No refractory or relapsed MM PATIENT CHARACTERISTICS: Age 18 and over Performance status Karnofsky 60-100% Life expectancy Not specified Hematopoietic Not specified Hepatic Bilirubin less than 1.5 mg/dL AST less than 2.5 times upper limit of normal Renal Not specified Other Not pregnant or nursing Negative pregnancy test Fertile patients must use 2 effective methods of contraception (including at least 1 highly active method) for at least 4 weeks before, during, and for at least 4 weeks after study participation No active serious infections uncontrolled by antibiotics No insufficient mental capacity that would preclude informed consent No other medical condition or reason that would preclude study participation Willing and able to comply with the FDA-mandated S.T.E.P.S program PRIOR CONCURRENT THERAPY: Biologic therapy No prior thalidomide Chemotherapy No more than 1 course of prior vincristine, doxorubicin, and dexamethasone Endocrine therapy Not specified Radiotherapy Not specified Surgery Not specified Other No concurrent alcohol consumption

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

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