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Thalidomide and Prednisone After Autologous Stem Cell Transplantation Multiple Myeloma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00049673
Recruitment Status : Completed
First Posted : January 27, 2003
Results First Posted : October 5, 2020
Last Update Posted : October 5, 2020
National Cancer Institute (NCI)
Eastern Cooperative Oncology Group
Information provided by (Responsible Party):
Canadian Cancer Trials Group ( NCIC Clinical Trials Group )

Brief Summary:

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 or disease Intervention/treatment Phase
Multiple Myeloma and Plasma Cell Neoplasm Drug: prednisone Drug: thalidomide Phase 3

Detailed Description:


  • 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.

For both arms, 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, and then annually thereafter.

After the treatment/observation period, patients are followed annually..

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 332 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Phase III Study Of Thalidomide And Prednisone As Maintenance Therapy Following Autologous Stem Cell Transplant in Patients With Multiple Myeloma
Actual Study Start Date : September 16, 2002
Actual Primary Completion Date : July 7, 2010
Actual Study Completion Date : September 19, 2013

Arm Intervention/treatment
Experimental: 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.
Drug: prednisone
Given orally

Drug: thalidomide
Given orally

No Intervention: Arm II
Patients undergo observation.

Primary Outcome Measures :
  1. Overall Survival [ Time Frame: 11 years ]
    Number of patients died from any cause during the study.

Secondary Outcome Measures :
  1. Disease Progression-free Survival [ Time Frame: 11 years ]
    Number of patients with disease progression or death

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 16 and over

Performance status

  • ECOG 0-2

Life expectancy

  • At least 6 months


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


  • 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


  • Creatinine no greater than 3 times ULN


  • No prior spontaneous deep vein thrombosis within the past 5 years

    • Catheter-associated thrombus allowed
  • No uncontrolled hypertension


  • No prior pulmonary embolism within the past 5 years


  • 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


Biologic therapy

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


  • See Disease Characteristics

Endocrine therapy

  • Not specified


  • Not specified


  • Not specified


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00049673

Show Show 18 study locations
Sponsors and Collaborators
NCIC Clinical Trials Group
National Cancer Institute (NCI)
Eastern Cooperative Oncology Group
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Study Chair: A. Keith Stewart, MD Mayo Clinic
Study Chair: Martha Q. Lacy, MD Mayo Clinic
Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: NCIC Clinical Trials Group Identifier: NCT00049673    
Other Study ID Numbers: MY10
CAN-NCIC-JMY10 ( Other Identifier: PDQ )
ECOG-NCIC-JMY10 ( Other Identifier: ECOG )
CELGENE-CAN-NCIC-MY10 ( Other Identifier: Celgene )
CDR0000258158 ( Other Identifier: PDQ )
First Posted: January 27, 2003    Key Record Dates
Results First Posted: October 5, 2020
Last Update Posted: October 5, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Canadian Cancer Trials Group ( NCIC Clinical Trials Group ):
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors