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Thalidomide and Prednisone After Autologous Stem Cell Transplantation in Treating Patients With Multiple Myeloma
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), April 2009
First Received: November 12, 2002   Last Updated: April 7, 2009   History of Changes
Sponsor: NCIC Clinical Trials Group
Collaborators: National Cancer Institute (NCI)
Eastern Cooperative Oncology Group
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00049673
  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: This randomized phase III trial is studying thalidomide and prednisone to see how well they work compared to observation in treating patients who have undergone stem cell transplantation for multiple myeloma.


Condition Intervention Phase
Multiple Myeloma and Plasma Cell Neoplasm
Drug: prednisone
Drug: thalidomide
Procedure: observation
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Active Control
Official Title: A Randomized Phase III Study Of Thalidomide And Prednisone As Maintenance Therapy Following Autologous Stem Cell Transplant in Patients With Multiple Myeloma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Overall survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to progression after reaching primary endpoint [ Designated as safety issue: No ]
  • Toxicity assessed by NCI CTC v2.0 [ Designated as safety issue: Yes ]
  • Quality of life assessed by EORTC QLQ C30 questionnaire [ Designated as safety issue: No ]
  • Incidence of venous thrombosis determined by objective imaging [ Designated as safety issue: No ]

Estimated Enrollment: 324
Study Start Date: September 2002
Estimated Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm I: Experimental
Patients receive oral thalidomide daily and oral prednisone every other day for 4 years in the absence of disease progression or unacceptable toxicity.
Drug: prednisone
Given orally
Drug: thalidomide
Given orally
Arm II: No Intervention
Patients undergo observation.
Procedure: observation
No intervention

Detailed Description:

OBJECTIVES:

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

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.

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 older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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/m^2) 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

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 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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00049673

  Hide Study Locations
Locations
United States, Arizona
Mayo Clinic Scottsdale Recruiting
Scottsdale, Arizona, United States, 85259-5499
Contact: Clinical Trials Office - All Mayo Clinic Locations     507-538-7623        
United States, Florida
Mayo Clinic - Jacksonville Recruiting
Jacksonville, Florida, United States, 32224
Contact: Clinical Trials Office - All Mayo Clinic Locations     507-538-7623        
United States, Georgia
MBCCOP - Medical College of Georgia Cancer Center Recruiting
Augusta, Georgia, United States, 30912
Contact: Anand P. Jillella, MD     706-721-2505        
United States, Michigan
CCOP - Michigan Cancer Research Consortium Recruiting
Ann Arbor, Michigan, United States, 48106
Contact: Philip J. Stella, MD     734-712-1000        
Oakwood Cancer Center at Oakwood Hospital and Medical Center Recruiting
Dearborn, Michigan, United States, 48123-2500
Contact: Clinical Trials Office - Oakwood Cancer Center at Oakwood Hosp     313-593-8090        
Genesys Hurley Cancer Institute Recruiting
Flint, Michigan, United States, 48503
Contact: Clinical Trials Office - Genesys Hurley Cancer Institute     810-762-8057        
Hurley Medical Center Recruiting
Flint, Michigan, United States, 48503
Contact: Clinical Trials Office - Hurley Medical Center     810-762-8057        
Mercy Regional Cancer Center at Mercy Hospital Recruiting
Port Huron, Michigan, United States, 48060
Contact: Philip J. Stella, MD     734-712-1000        
Foote Memorial Hospital Recruiting
Jackson, Michigan, United States, 49201
Contact: Philip J. Stella, MD     734-712-1000        
Saint Joseph Mercy Cancer Center Recruiting
Ann Arbor, Michigan, United States, 48106-0995
Contact: Philip J. Stella, MD     734-712-1000        
Seton Cancer Institute at Saint Mary's - Saginaw Recruiting
Saginaw, Michigan, United States, 48601
Contact: Clinical Trials Office - Seton Cancer Institute - Saginaw     989-776-8411        
Sparrow Regional Cancer Center Recruiting
Lansing, Michigan, United States, 48912-1811
Contact: Clinical Trials Office - Sparrow Regional Cancer Center     517-364-2890        
St. John Macomb Hospital Recruiting
Warren, Michigan, United States, 48093
Contact: Philip J. Stella, MD     734-712-1000        
St. Joseph Mercy Oakland Recruiting
Pontiac, Michigan, United States, 48341-2985
Contact: Philip J. Stella, MD     734-712-1000        
St. Mary Mercy Hospital Recruiting
Livonia, Michigan, United States, 48154
Contact: Philip J. Stella, MD     734-712-1000        
Van Elslander Cancer Center at St. John Hospital and Medical Center Recruiting
Grosse Pointe Woods, Michigan, United States, 48236
Contact: Clincial Trials Office - Van Elslander Cancer Center at St. Jo     313-343-3166        
United States, Minnesota
Mayo Clinic Cancer Center Recruiting
Rochester, Minnesota, United States, 55905
Contact: Clinical Trials Office - All Mayo Clinic Locations     507-538-7623        
United States, Pennsylvania
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center Recruiting
Wilkes-Barre, Pennsylvania, United States, 18711
Contact: Clinical Trials Office - Frank M. and Dorothea Henry Cancer Ce     570-271-5251        
Geisinger Cancer Institute at Geisinger Health Recruiting
Danville, Pennsylvania, United States, 17822-0001
Contact: Clinical Trials Office - Geisinger Cancer Institute     570-271-5251        
Geisinger Medical Group - Scenery Park Recruiting
State College, Pennsylvania, United States, 16801
Contact: Adel Z. Makary, MD     570-271-6045        
Canada, Alberta
Cross Cancer Institute at University of Alberta Recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Contact: Andrew Belch     780-432-8757        
Tom Baker Cancer Centre - Calgary Recruiting
Calgary, Alberta, Canada, T2N 4N2
Contact: Nizar Jacques Bahlis     403-944-1564        
Canada, British Columbia
British Columbia Cancer Agency - Vancouver Cancer Centre Recruiting
Vancouver, British Columbia, Canada, V5Z 4E6
Contact: Kevin W.J. Song     604-875-4863        
Canada, Manitoba
CancerCare Manitoba Recruiting
Winnipeg, Manitoba, Canada, R3E 0V9
Contact: Morel Rubinger     204-787-3594        
Canada, New Brunswick
Moncton Hospital Recruiting
Moncton, New Brunswick, Canada, E1C 6Z8
Contact: Sheldon Rubin     506-857-2881        
Saint John Regional Hospital Recruiting
Saint John, New Brunswick, Canada, E2L 4L2
Contact: Margot Burnell     506-648-6884        
Canada, Newfoundland and Labrador
Doctor H. Bliss Murphy Cancer Centre Recruiting
St. John's, Newfoundland and Labrador, Canada, AIB 3V6
Contact: Kirsty A. Tompkins     709-777-8062        
Canada, Nova Scotia
Nova Scotia Cancer Centre Recruiting
Halifax, Nova Scotia, Canada, B3H 1V7
Contact: Darrell White     902-473-7922        
Canada, Ontario
Cancer Centre of Southeastern Ontario at Kingston General Hospital Recruiting
Kingston, Ontario, Canada, K7L 5P9
Contact: John H. Matthews     613-533-6329        
Edmond Odette Cancer Centre at Sunnybrook Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Kevin R. Imrie     416-480-5000        
London Regional Cancer Program at London Health Sciences Centre Recruiting
London, Ontario, Canada, N6A 4L6
Contact: Michael J. Kovacs     519-685-8500        
Margaret and Charles Juravinski Cancer Centre Recruiting
Hamilton, Ontario, Canada, L8V 5C2
Contact: Deborah Marcellus     905-575-9827        
Princess Margaret Hospital Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Suzanne Marie Trudel     416-946-4566        
Canada, Quebec
CHUS-Hopital Fleurimont Recruiting
Sherbrooke, Quebec, Canada, J1H 5N4
Contact: Richard Le Blanc     819-346-1110        
Hopital du Saint-Sacrement - Quebec Recruiting
Quebec City, Quebec, Canada, G1S 4L8
Contact: Guy Cantin     418-682-7511        
Maisonneuve-Rosemont Hospital Recruiting
Montreal, Quebec, Canada, H1T 2M4
Contact: Jean Roy     514-252-3404        
McGill Cancer Centre at McGill University Recruiting
Montreal, Quebec, Canada, H2W 1S6
Contact: Chaim Shustik     514-398-1444        
Canada, Saskatchewan
Saskatoon Cancer Centre at the University of Saskatchewan Recruiting
Saskatoon, Saskatchewan, Canada, S7N 4H4
Contact: Michael Voralia     306-655-2925        
Sponsors and Collaborators
NCIC Clinical Trials Group
Eastern Cooperative Oncology Group
Investigators
Study Chair: A. Keith Stewart, MD Mayo Clinic Scottsdale
Study Chair: Philip R. Greipp, MD Mayo Clinic
  More Information

Additional Information:
No publications provided

Responsible Party: NCIC-Clinical Trials Group ( Lois Shepherd )
Study ID Numbers: CDR0000258158, CAN-NCIC-MY10, CAN-NCIC-JMY10, ECOG-NCIC-JMY10
Study First Received: November 12, 2002
Last Updated: April 7, 2009
ClinicalTrials.gov Identifier: NCT00049673     History of Changes
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Anti-Infective Agents
Prednisone
Immunologic Factors
Thalidomide
Blood Protein Disorders
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Paraproteinemias
Hemostatic Disorders
Hormones
Anti-Bacterial Agents
Hemorrhagic Disorders
Therapeutic Uses
Cardiovascular Diseases
Growth Inhibitors
Angiogenesis Modulating Agents
Immunoproliferative Disorders
Neoplasms by Histologic Type
Immune System Diseases
Antineoplastic Agents, Hormonal
Hematologic Diseases
Growth Substances
Vascular Diseases
Angiogenesis Inhibitors
Immunosuppressive Agents
Glucocorticoids
Pharmacologic Actions
Multiple Myeloma

ClinicalTrials.gov processed this record on November 22, 2009