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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)


Phase 2
18 Years
N/A
Not Enrolling
Both
Multiple Myeloma and Plasma Cell Neoplasm

Thank you

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 InstituteBuffalo, New York  14263