Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Completed 18 and over NCI RPCI-RP-0215 NCT00054158

Objectives

1. 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.
2. Determine the ability to collect peripheral blood stem cells in patients after treatment with this regimen.

Entry Criteria

Disease Characteristics:

• Newly diagnosed stage I, II, or III multiple myeloma (MM)



• No refractory or relapsed MM

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

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

Expected Enrollment

Approximately 17-37 patients will be accrued for this study.

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.

Trial Contact Information

Trial Lead Organizations

Roswell Park Cancer Institute

Asher Chanan-Khan, MD, Protocol chair		Ph: 716-845-3221; 800-685-6825 Email: Asher.Chanan-Khan@RoswellPark.org

Registry Information
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)
Trial Start Date		2004-08-31
Registered in ClinicalTrials.gov		NCT00054158
Date Submitted to PDQ		2002-12-17
Information Last Verified		2006-04-01
NCI Grant/Contract Number		CA16056

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