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Title:
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A Trial of Single Autologous Transplant with or without Consolidation Therapy versus Tandem Autologous Transplant with Lenalidomide Maintenance for Patients with Multiple Myeloma - IRB #10-057A
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Treatments:
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Bortezomib (Velcade™, PS-341), Dexamethasone, Lenalidomide, Stem Cell Transplantation
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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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Bortezomib (Velcade™, PS-341), Lenalidomide
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Comments:
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Providence Portland Medical Center is the site that is able to register patients. For potential patient referrals contact Sarah Linehan, transplant coordinator at x58646 or email: sarah.linehan@providence.org. You may also contact Roxanne Payne, FNP at x56737 or email: Roxanne.payne@providence.org.
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Eligibility:
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Patients must meet the criteria for symptomatic multiple myeloma, and patients who are 70 years of age, or younger, at time of enrollment. Patients who have received at least two cycles of any regimen as initial systemic therapy and are within 2-12 months of the first dose of initial therapy (this time frame excludes the time for mobilization therapy). Patients must be able to receive high-dose melphalan within 8 weeks after the initiation of mobilization therapy whether delivered at the transplant center or at a referring center. Cardiac function: left ventricular ejection fraction at rest greater than 40 percent. Hepatic: bilirubin less than 2 times the upper limit of normal and ALT and AST less than 2.5 times the upper limit of normal. Renal: Creatinine clearance of grater than or equal to 40 mL/min, estimated or calculated. Pulmonary: DLCO, FEV1, FVC grater than 50 percent of predicted value (corrected for hemoglobin). Patients with an adequate autologous graft defined as a cryopreserved PBSC graft containing greater than or equal to 4 x 10^6 CD34+ cells/kg patient weight. The graft may not be CD34+ selected or otherwise manipulated to remove tumor or other cells. The graft can be collected at the transplanting institution or by a referring center. The autograft must be stored so that there are two products each containing at least 2 x 10^6 CD34+ cells/kg patient weight.
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Participating Sites:
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Providence Portland Medical Center
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