Thalidomide and Prednisone After Autologous Stem Cell Transplantation Multiple Myeloma

Study Overview
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Brief Summary
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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.

Detailed Description
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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. 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.

Official Title
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A Randomized Phase III Study Of Thalidomide And Prednisone As Maintenance Therapy Following Autologous Stem Cell Transplant in Patients With Multiple Myeloma

Conditions
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Multiple Myeloma and Plasma Cell Neoplasm

Intervention / Treatment
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* Drug: prednisone
* Drug: thalidomide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I<br>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<br>* Given orally<br>Drug: thalidomide<br>* Given orally<br>|
| No Intervention: Arm II<br>Patients undergo observation. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival | Number of patients died from any cause during the study. | 9 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease Progression-free Survival | Number of patients with disease progression or death | 9 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma