Thalidomide and Prednisone After Autologous Stem Cell Transplantation Multiple Myeloma (NCT00049673) | Clinical Trial Compass
CompletedPhase 3
Thalidomide and Prednisone After Autologous Stem Cell Transplantation Multiple Myeloma
Canada332 participantsStarted 2002-10-15
Plain-language 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.
Who can participate
Age range16 Years
SexALL
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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 allowe…