Clinical Trial: Thalidomide and Prednisone After Autologous Stem Cell Transplantation in Treating Patients With Multiple Myeloma

This study is currently recruiting patients.

Sponsored by: National Cancer Institute of Canada
Information provided by: National Cancer Institute (NCI)

Purpose

RATIONALE: Thalidomide may stop the growth of multiple myeloma by stopping blood flow to the tumor. It is not yet known whether combining thalidomide with prednisone and giving them after autologous stem cell transplantation may be effective in treating multiple myeloma.

PURPOSE: Randomized phase III trial to determine the effectiveness of combining thalidomide with prednisone in treating patients who have undergone stem cell transplantation for multiple myeloma.

Condition Treatment or Intervention Phase
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma
 Drug: prednisone
 Drug: thalidomide
 Procedure: anti-cytokine therapy
 Procedure: antiangiogenesis therapy
 Procedure: biological response modifier therapy
 Procedure: endocrine therapy
 Procedure: growth factor antagonist therapy
 Procedure: hormone therapy
 Procedure: steroid therapy
Phase III

MedlinePlus related topics:  Multiple Myeloma

Study Type: Interventional
Study Design: Treatment

Official Title: Phase III Randomized Study of Thalidomide and Prednisone as Maintenance Therapy After Autologous Stem Cell Transplantation in Patients With Multiple Myeloma

Further Study Details: 

OBJECTIVES:

OUTLINE: This is a randomized, non-blinded, multicenter study. Patients are stratified according to treatment center, age (under 60 vs 60 and over), and response to prior transplantation (complete vs incomplete). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive oral thalidomide daily and oral prednisone every other day for 4 years in the absence of disease progression or unacceptable toxicity.
  • Arm II: Patients undergo observation. Patients are assessed (including for quality of life) regularly throughout the treatment/observation period: at baseline, every 2 months for 6 months, every 3 months for 3.5 years, every 6 months for 1 year, and then annually thereafter.

After the treatment/observation period, patients are followed every 6 months for 1 year and then annually thereafter.

PROJECTED ACCRUAL: A total of 324 patients will be accrued for this study within 3.5 years.

Eligibility

Ages Eligible for Study:  16 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

PATIENT CHARACTERISTICS: Age

  • 16 and over

Performance status

  • ECOG 0-2

Life expectancy

  • At least 6 months

Hematopoietic

  • No prior hereditary hypercoaguable disorder
  • Granulocyte count at least 1,000/mm^3
  • Platelet count at least 75,000/mm^3

Hepatic

  • Bilirubin no greater than 2 times upper limit of normal (ULN)
  • AST and/or ALT no greater than 2 times ULN
  • Alkaline phosphatase no greater than 2 times ULN

Renal

  • Creatinine no greater than 3 times ULN

Cardiovascular

  • No prior spontaneous above-knee deep vein thrombosis
  • Catheter-associated thrombus allowed
  • No uncontrolled hypertension

Pulmonary

Other

  • No other prior malignancy within the past 5 years except adequately treated squamous cell or basal cell skin cancer or carcinoma in situ of the cervix
  • No prior gastric ulceration or bleeding within the past 5 years
  • No prior documented lupus anti-coagulant or anti-phospholipid antibody
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile female patients must use 2 effective methods of contraception for 1 month prior, during, and 1 month after study participation
  • Male patients must use effective barrier contraception during and for 1 month after study participation
  • No avascular necrosis of the hips or shoulders
  • No grade 2 or greater peripheral neuropathy causing symptomatic dysfunction (vincristine-induced sensory symptoms allowed)
  • No diabetes with end-organ damage defined as:
  • Documented diabetic neuropathy
  • Retinal vascular proliferation requiring treatment
  • Cardiovascular disease requiring active therapy
  • Willing to complete quality of life questionnaires
  • Employment does not prohibit the use of sedatives
  • No other major medical illness or condition that would preclude study participation

PRIOR CONCURRENT THERAPY: Biologic therapy

  • See Disease Characteristics
  • No prior thalidomide

Chemotherapy

  • See Disease Characteristics

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Not specified

Other

  • No other concurrent anti-cancer therapy
  • No other concurrent investigational therapy

Location and Contact Information


Canada, Alberta
      Cross Cancer Institute, Edmonton,  Alberta,  T6G 1Z2,  Canada; Recruiting
Andrew R. Belch, MD  780-432-8757    andrewbe@cancerboard.ab.ca 

      Tom Baker Cancer Centre - Calgary, Calgary,  Alberta,  T2N 4N2,  Canada; Recruiting
Ramakrishman Paramuswaran, MD  403-944-1564 

Canada, British Columbia
      British Columbia Cancer Agency, Vancouver,  British Columbia,  V5Z 4E6,  Canada; Recruiting
Kevin W.J. Song, MD  604-875-4863    ksong@bccancer.bc.ca 

Canada, Manitoba
      CancerCare Manitoba, Winnipeg,  Manitoba,  R3E 0V9,  Canada; Recruiting
Morel Rubinger, MD, FRCPC  204-787-2113    Morel.rubinger@cancercare.mb.ca 

Canada, New Brunswick
      Moncton Hospital, Moncton,  New Brunswick,  E1C 4B7,  Canada; Recruiting
Sheldon H. Rubin, MD  506-857-2881 

Canada, Newfoundland and Labrador
      Newfoundland Cancer Treatment and Research Foundation, St. Johns,  Newfoundland and Labrador,  A1B 3V6,  Canada; Recruiting
Kirsty A. Tompkins  709-777-8062 

Canada, Nova Scotia
      Nova Scotia Cancer Centre at Queen Elizabeth II Health Sciences Centre, Halifax,  Nova Scotia,  B3H 1V7,  Canada; Recruiting
Darrell White, MD  902-473-7922    d.white@dal.ca 

Canada, Ontario
      Cancer Care Ontario - Windsor Regional Cancer Centre, Windsor,  Ontario,  N8W 2X3,  Canada; Recruiting
Dolores A. Sicheri, MD, FRCPC  519-253-3191 ext. 58504    dsicheri@WRCC.on.ca 

      Cancer Care Ontario-London Regional Cancer Centre, London,  Ontario,  N6A 4L6,  Canada; Recruiting
Michael J. Kovacs, MD  519-685-8500 ext. 55182 

      Margaret and Charles Juravinski Cancer Centre, Hamilton,  Ontario,  L8V 5C2,  Canada; Recruiting
Deborah C. Marcellus, MD  905-575-9827 

      Princess Margaret Hospital, Toronto,  Ontario,  M5G 2C1,  Canada; Recruiting
Keith Stewart, MD  416-946-4566    kstewart@uhnres.utoronto.ca 

      Toronto Sunnybrook Regional Cancer Centre, Toronto,  Ontario,  M4N 3M5,  Canada; Recruiting
Kevin Imrie, MD  416-480-4757    kevin.imrie@utoronto.ca 

Canada, Quebec
      CHUS-Hopital Fleurimont, Sherbrooke,  Quebec,  J1H 5N4,  Canada; Recruiting
Richard Leblanc, MD  819-346-1110 ext. 14816 

      Hopital de L'Enfant Jesus, Quebec City,  Quebec,  G1J 1Z4,  Canada; Recruiting
Guy Cantin, MD  418-649-5727 

      Hopital Du Sacre-Coeur de Montreal, Montreal,  Quebec,  H4J 1C5,  Canada; Recruiting
Guylaine Gaudet, MD  514-338-2050    guylainegaudet@hotmail.com 

      Hopital du Saint-Sacrement, Quebec, Quebec City,  Quebec,  G1S 4L8,  Canada; Recruiting
Guy Cantin, MD  418-682-7511 

      Maisonneuve-Rosemont Hospital, Montreal,  Quebec,  H1T 2M4,  Canada; Recruiting
Jean Roy, MD  514-252-3404 

      McGill Cancer Centre, Montreal,  Quebec,  H2W 1S6,  Canada; Recruiting
Chaim Shustik, MD  514-398-1444    shustikc@muhchem.mcgill.ca 

Canada, Saskatchewan
      Saskatoon Cancer Centre, Saskatoon,  Saskatchewan,  S7N 4H4,  Canada; Recruiting
Michael Voralia  306-655-2925 

Study chairs or principal investigators

Keith Stewart, MD,  Study Chair,  Princess Margaret Hospital   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000258158; CAN-NCIC-MY10; NCT00049673
Record last reviewed:  September 2004
Last Updated:  April 4, 2005
Record first received:  November 12, 2002
ClinicalTrials.gov Identifier:  NCT00049673
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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