Autologous Transplant for Multiple Myeloma
Multiple Myeloma

About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring stem cell transplantation, chemotherapy, multiple myeloma, autologous
Eligibility Criteria
Inclusion Criteria: Patients meeting the Durie and Salmon criteria for initial diagnosis of multiple myeloma, requiring therapy and meeting one of the following: After initial therapy in either first complete or partial remission or no objective response After achieving initial response and later disease progression, patient will be eligible after subsequent therapy upon achievement of either complete or partial response Is not eligible or has refused any protocols of higher priority 18 - 75 years of age Adequate organ function defined as: Hematologic: hemoglobin ≥ 8 gm/dl (untransfused), white blood cells (WBC) ≥ 3000/μl, absolute neutrophil count (ANC) ≥ 1500/μl, platelets ≥ 100,000/μl (untransfused) Cardiac: no active ischemia, left ventricular ejection fraction > 45% by MUGA scan Hepatic: bilirubin < 2.0 mg/dl, ALT < 3x the upper limit of normal Pulmonary: FEV1-Forced Expiratory Volume in One Second AND Forced vital capacity (FVC) >50% predicted and Carbon Monoxide Diffusing Capacity (DLCO) (corrected) > 50% predicted Performance status: Karnofsky performance of > 80%. Free of active uncontrolled infection at the time of study entry. At time of study enrollment > 4 weeks from prior myelosuppressive chemotherapy; and > 6 weeks from prior nitrosoureas. Patients must exercise informed voluntary consent and sign a consent form approved by the University of Minnesota IRB: Human Subjects Committee. Exclusion Criteria: Patients will be ineligible if they have advanced myeloma refractory and unresponsive to salvage chemotherapy regimens. Female patients who are pregnant (positive b-HCG) or breastfeeding will be excluded from study entry. In addition fertile men or women unwilling to use contraceptive techniques during and for 12 months following treatment, particularly after thalidomide will also be excluded from study entry.
Sites / Locations
- Masonic Cancer Center, University of Minnesota
Arms of the Study
Arm 1
Experimental
Chemotherapy and Transplant Treatment
Patients receiving peripheral blood stem cell mobilization, chemotherapy (cyclophosphamide + Mesna, growth factor (Granulocyte-colony stimulating factor) and autologous Peripheral Blood Stem Cell transplant with high dose melphalan (200 mg/m^2). Post-transplant maintenance therapy is then prescribed if appropriate.