Study of KIR-Ligand Mismatched Haplo-Identical Natural Killer Cells Transfused Before Autologous Stem Cell Transplant
Multiple Myeloma
About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring Myeloma, Transplant, Relapsed, Donor, Stem Cell, Thalidomide, Dexamethasone, Cisplatin, Adriamycin, Cyclophosphamide, Etoposide, Melphalan
Eligibility Criteria
Inclusion Criteria: MM in frank relapse after a single or tandem transplant or high risk Myeloma Patients with prior transplant must be more than 4 months after the last transplant Karnofsky performance score >or =70, or a performance score of 50-70 exclusively due to bone pain caused by myeloma 18 years of age or older An expected survival greater than 3 months ANC >1,000/microliters, platelet count > 100,000/microliters Donor and patient must have signed an IRB-approved consent and been informed about the investigational nature of the study Donor must have negative serology for HIV Available haplo-identical family donor fit to undergo leukapheresis and mismatched for KIR-ligand(s) with the patient in the graft-versus host direction. Stored cells for autografting of at least 30 million CD34+ cells/kg Back-up cells of at least 20 million CD34+ cells/kg in case of non-engraftment. There must be an unambiguous marker for response to therapy in the first ten patients. Therefore the patient must have detectable and quantifiable M-protein or light chain excretion in urine, light chain quantification in serum (FREELITE) or clear radiological signal lesion(s) in order to be eligible After 10 relapsed patients have been treated and toxicity is deemed acceptable, high-risk myeloma (defined as the presence of abnormal cytogenetics or metaphase analysis) patients without relapse can be entered Exclusion Criteria: Intravenous chemotherapy or antibody therapy affecting T-lymphocytes and/or natural killer cells e.g. cyclophosphamide, melphalan, ATG, Campath-1H etc. within the past 2 weeks prior to commencement of conditioning. Last therapy is less than 14 days prior to starting fludarabine Fever or active infection, requiring IV antibiotics Liver function: total bilirubin > 2xULN or AST/ALT >3xULN Renal function: patients on dialysis
Sites / Locations
- University of Arkansas for Medical Sciences/MIRT