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Title:
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An Intergroup Phase III Randomized Controlled Trial Comparing Melphalan, Prednisone and Thalidomide (MPT) Versus Melphalan, Prednisone and Lenalidomide (Revlimid(tm)) (MPR) in Newly Diagnosed Multiple Myeloma Patients Who Are Not Candidates for High-Dose Therapy - IRB# 08-95A
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Treatments:
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Asprin, Lenalidomide, Melphalan, Prednisone, Thalidomide
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Disease Site:
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Multiple myeloma
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Disease SubSite:
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Drug Provided:
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Lenalidomide, Thalidomide
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Comments:
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Eligibility:
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Newly diagnosed multiple myeloma (MM), meeting the following criteria: Bone marrow plasmacytosis with equal to or less than 10% plasma cells or sheets of plasma cells or biopsy proven plasmacytoma. Symptomatic disease with evidence of end-organ damage at initial diagnosis that prompted the initiation of therapy, including equal to or less than 1 of the following: Anemia, Hypercalcemia, Bone disease (lytic bone lesions or pathologic fracture), Renal dysfunction. No smoldering MM, defined by all of the following: Serum monoclonal protein equal to or less than 3 g/dL, Bone marrow plasma cells equal to or less than 10% or greater, Absence of anemia, hypercalcemia, lytic bone lesions, or renal dysfunction, No monoclonal gammopathy of undetermined significance, defined by all of the following: Serum monoclonal protein < 3 g/dL, Bone marrow plasma cells equal to or greater than 10%, Absence of anemia, hypercalcemia, lytic bone lesions, or renal dysfunction, Previously untreated for MM, Patients 18 to 64 years old must not be a candidate for autologous stem cell transplantation or have declined transplantation or other alternative treatment. Prior/Concurrent Therapy:See Disease Characteristics. No prior treatment for myeloma except for either of the following: Prednisone or dexamethasone treatment for myeloma for a duration of less than 4 weeks. Prednisone or dexamethasone in combination with thalidomide or lenalidomide for a duration of less than 2 weeks total. Concurrent bisphosphonates or growth factors (i.e., erythropoietin) for MM allowed. Concurrent localized radiation therapy is allowed for pain control at the physician’s discretion.
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Participating Sites:
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Adventist Medical Center, Northwest Cancer Specialists, Providence Milwaukie Hospital, Providence Portland Medical Center, Providence St. Vincent Medical Center, Southwest Washington Medical Center
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