A Phase II Study of VAD (Vincristine, Adriamycin, Dexamethasone) Plus Thalidomide (Low Dose) as Frontline Therapy for Newly Diagnosed Patients With Multiple Myeloma (MM)
18 Years
N/A
Both
Multiple Myeloma and Plasma Cell Neoplasm
Trial Information
A Phase II Study of VAD (Vincristine, Adriamycin, Dexamethasone) Plus Thalidomide (Low Dose) as Frontline Therapy for Newly Diagnosed Patients With Multiple Myeloma (MM)
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.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Principal Investigator
Asher A. Chanan-Khan, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Roswell Park Cancer Institute
Authority:
United States: Federal Government
Study ID:
RP 02-15
NCT ID:
NCT00054158
Start Date:
August 2004
Completion Date:
Related Keywords:
- Multiple Myeloma and Plasma Cell Neoplasm
- stage I multiple myeloma
- stage II multiple myeloma
- stage III multiple myeloma
- Neoplasms
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Plasmacytoma
Name | Location |
|---|---|
| Roswell Park Cancer Institute | Buffalo, New York 14263 |
