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Combination Chemotherapy and Thalidomide in Treating Patients With Stage I, Stage II, or Stage III Multiple Myeloma
This study has been completed.
Study NCT00054158   Information provided by National Cancer Institute (NCI)
First Received: February 5, 2003   Last Updated: August 23, 2008   History of Changes

February 5, 2003
August 23, 2008
August 2004
 
 
 
Complete list of historical versions of study NCT00054158 on ClinicalTrials.gov Archive Site
 
 
 
Combination Chemotherapy and Thalidomide in Treating Patients With Stage I, Stage II, or Stage III Multiple Myeloma
A Phase II Study of VAD (Vincristine, Adriamycin, Dexamethasone) Plus Thalidomide (Low Dose) as Frontline Therapy for Newly Diagnosed Patients With Multiple Myeloma (MM)

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.

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.

Phase II
Interventional
Treatment, Open Label
Multiple Myeloma and Plasma Cell Neoplasm
  • Drug: dexamethasone
  • Drug: doxorubicin hydrochloride
  • Drug: thalidomide
  • Drug: vincristine sulfate
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
 

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00054158
 
CDR0000269903, RPCI-RP-0215
Roswell Park Cancer Institute
National Cancer Institute (NCI)
Study Chair: Asher A. Chanan-Khan, MD Roswell Park Cancer Institute
National Cancer Institute (NCI)
April 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP