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Last Modified: 4/6/2009     First Published: 11/1/2002  
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Phase III Randomized Study of Thalidomide and Prednisone as Maintenance Therapy After Autologous Stem Cell Transplantation in Patients With Multiple Myeloma

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentActive16 and overNCI, OtherCAN-NCIC-MY10
NCT00049673, NCIC-MY.10, CAN-NCIC-JMY10, ECOG-NCIC-JMY10, MY10

Objectives

  1. Compare overall survival of patients with multiple myeloma treated with thalidomide and prednisone as maintenance therapy vs observation alone after autologous stem cell transplantation.
  2. Compare progression-free survival of patients treated with these regimens.
  3. Compare quality of life of patients treated with these regimens.
  4. Compare toxic effects of these regimens in these patients.
  5. Compare the objective venous thromboembolism rate in symptomatic patients treated with these regimens.

Entry Criteria

Disease Characteristics:

  • Histologically confirmed multiple myeloma as evidenced by one of the following:
    • Biopsy of an osteolytic lesion or soft tissue tumor composed of plasma cells
    • Bone marrow aspirate and/or biopsy demonstrating at least 10% plasmacytosis
    • Bone marrow less than 10% plasma cells with at least 1 bony lesion and meets the M-protein criteria as below


  • Detectable serum M-component of IgG, IgA, IgD, or IgE at initial diagnosis

    OR



  • Urinary excretion of light chain (Bence Jones) protein at least 1.0 gm/24 hrs if only light chain disease (urine M-protein) was present at initial diagnosis


  • Previously treated with autologous stem cell transplantation after high-dose melphalan (200 mg/m2) within the past 60-100 days
    • Received transplantation within 1 year of the beginning of initial chemotherapy for multiple myeloma
    • No evidence of disease progression


Prior/Concurrent Therapy:

Biologic therapy

  • See Disease Characteristics
  • No prior double autologous or allogeneic hematopoietic stem cell transplantation
  • 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

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/mm3
  • Platelet count at least 75,000/mm3

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 deep vein thrombosis within the past 5 years
    • Catheter-associated thrombus allowed
  • No uncontrolled hypertension

Pulmonary

  • No prior pulmonary embolism within the past 5 years

Other

  • No other prior or concurrent malignancy except adequately treated squamous cell or basal cell skin cancer or carcinoma in situ of the cervix or any cancer treated more than 5 years prior to study entry and presumed cured
  • 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

Expected Enrollment

324

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

Outcomes

Primary Outcome(s)

Overall survival

Secondary Outcome(s)

Time to progression after reaching primary endpoint
Toxicity assessed by NCI CTC v2.0
Quality of life assessed by EORTC QLQ C30 questionnaire
Incidence of venous thrombosis determined by objective imaging

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 up to 4 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.

Trial Contact Information

Trial Lead Organizations

NCIC-Clinical Trials Group

A. Keith Stewart, MD, Protocol chair
Ph: 480-301-4411

Eastern Cooperative Oncology Group

Philip Greipp, MD, Protocol chair
Ph: 507-284-9094
Email: greipp.philip@mayo.edu

Trial Sites

U.S.A.
Arizona
  Scottsdale
 Mayo Clinic Scottsdale
 Clinical Trials Office - All Mayo Clinic Locations
Ph: 507-538-7623
Florida
  Jacksonville
 Mayo Clinic - Jacksonville
 Clinical Trials Office - All Mayo Clinic Locations
Ph: 507-538-7623
Georgia
  Augusta
 MBCCOP - Medical College of Georgia Cancer Center
 Anand Jillella, MD
Ph: 706-721-2505
Michigan
  Ann Arbor
 CCOP - Michigan Cancer Research Consortium
 Philip Stella, MD
Ph: 734-712-1000
 Saint Joseph Mercy Cancer Center
 Philip Stella, MD
Ph: 734-712-1000
  Dearborn
 Oakwood Cancer Center at Oakwood Hospital and Medical Center
 Clinical Trials Office - Oakwood Cancer Center at Oakwood Hospital and Medical Center
Ph: 313-593-8090
  Flint
 Genesys Hurley Cancer Institute
 Clinical Trials Office - Genesys Hurley Cancer Institute
Ph: 810-762-8057
 Hurley Medical Center
 Clinical Trials Office - Hurley Medical Center
Ph: 810-762-8057
  Grosse Pointe Woods
 Van Elslander Cancer Center at St. John Hospital and Medical Center
 Clincial Trials Office - Van Elslander Cancer Center at St. John Hospital and Medical Center
Ph: 313-343-3166
  Jackson
 Foote Memorial Hospital
 Philip Stella, MD
Ph: 734-712-1000
  Lansing
 Sparrow Regional Cancer Center
 Clinical Trials Office - Sparrow Regional Cancer Center
Ph: 517-364-2890
  Livonia
 St. Mary Mercy Hospital
 Philip Stella, MD
Ph: 734-712-1000
  Pontiac
 St. Joseph Mercy Oakland
 Philip Stella, MD
Ph: 734-712-1000
  Port Huron
 Mercy Regional Cancer Center at Mercy Hospital
 Philip Stella, MD
Ph: 734-712-1000
  Saginaw
 Seton Cancer Institute at Saint Mary's - Saginaw
 Clinical Trials Office - Seton Cancer Institute - Saginaw
Ph: 989-776-8411
  Warren
 St. John Macomb Hospital
 Philip Stella, MD
Ph: 734-712-1000
Minnesota
  Rochester
 Mayo Clinic Cancer Center
 Clinical Trials Office - All Mayo Clinic Locations
Ph: 507-538-7623
Pennsylvania
  Danville
 Geisinger Cancer Institute at Geisinger Health
 Clinical Trials Office - Geisinger Cancer Institute
Ph: 570-271-5251
  State College
 Geisinger Medical Group - Scenery Park
 Adel Makary, MD
Ph: 570-271-6045
  Wilkes-Barre
 Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
 Clinical Trials Office - Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
Ph: 570-271-5251
Canada
Alberta
  Calgary
 Tom Baker Cancer Centre - Calgary
 Nizar Jacques Bahlis
Ph: 403-944-1564
  Edmonton
 Cross Cancer Institute at University of Alberta
 Andrew Belch
Ph: 780-432-8757
British Columbia
  Vancouver
 British Columbia Cancer Agency - Vancouver Cancer Centre
 Kevin W.J. Song
Ph: 604-875-4863
Manitoba
  Winnipeg
 CancerCare Manitoba
 Morel Rubinger
Ph: 204-787-3594
New Brunswick
  Moncton
 Moncton Hospital
 Sheldon Rubin
Ph: 506-857-2881
  Saint John
 Saint John Regional Hospital
 Margot Burnell
Ph: 506-648-6884
Newfoundland and Labrador
  St. John's
 Doctor H. Bliss Murphy Cancer Centre
 Kirsty A. Tompkins
Ph: 709-777-8062
Nova Scotia
  Halifax
 Nova Scotia Cancer Centre
 Darrell White
Ph: 902-473-7922
Ontario
  Hamilton
 Margaret and Charles Juravinski Cancer Centre
 Deborah Marcellus
Ph: 905-575-9827
  Kingston
 Cancer Centre of Southeastern Ontario at Kingston General Hospital
 John H. Matthews
Ph: 613-533-6329
  London
 London Regional Cancer Program at London Health Sciences Centre
 Michael J. Kovacs
Ph: 519-685-8500
  Toronto
 Edmond Odette Cancer Centre at Sunnybrook
 Kevin R. Imrie
Ph: 416-480-5000
 Princess Margaret Hospital
 Suzanne Marie Trudel
Ph: 416-946-4566
Quebec
  Montreal
 Maisonneuve-Rosemont Hospital
 Jean Roy
Ph: 514-252-3404
 McGill Cancer Centre at McGill University
 Chaim Shustik
Ph: 514-398-1444
  Quebec City
 Hopital du Saint-Sacrement - Quebec
 Guy Cantin
Ph: 418-682-7511
  Sherbrooke
 CHUS-Hopital Fleurimont
 Richard Le Blanc
Ph: 819-346-1110
Saskatchewan
  Saskatoon
 Saskatoon Cancer Centre at the University of Saskatchewan
 Michael Voralia
Ph: 306-655-2925

Registry Information
Official Title A Randomized Phase III Study Of Thalidomide And Prednisone As Maintenance Therapy Following Autologous Stem Cell Transplant in Patients With Multiple Myeloma
Trial Start Date 2002-09-16
Trial Completion Date 2009-07-01 (estimated)
Registered in ClinicalTrials.gov NCT00049673
Date Submitted to PDQ 2002-09-24
Information Last Verified 2009-04-01

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.

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