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

Overview

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.

Full Title of Study: “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 Type

• Study Type: Interventional
• Study Design
  • Primary Purpose: Treatment
  • Masking: None (Open Label)
• Study Primary Completion Date: April 2006

Detailed Description

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.

Interventions

• Drug: dexamethasone
• Drug: doxorubicin hydrochloride
• Drug: thalidomide
• Drug: vincristine sulfate

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 120 Years

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • Roswell Park Cancer Institute
• Overall Official(s)
  • Asher A. Chanan-Khan, MD, Study Chair, Roswell Park Cancer Institute