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

Sponsor

Roswell Park Cancer Institute (Other)

Overall Status

Completed

CT.gov ID

NCT00054158

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Location

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma and Plasma Cell Neoplasm	Drug: dexamethasone Drug: doxorubicin hydrochloride Drug: thalidomide Drug: vincristine sulfate	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

24 participants

Masking:

None (Open Label)

Primary Purpose:

Treatment

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)

Study Start Date :

Aug 1, 2004

Actual Primary Completion Date :

Apr 1, 2006

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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