UARK 2003-18, A Phase II Study of KIR-Ligand Mismatched Haplo-Identical Natural Killer Cells Transfused Before Autologous Stem Cell Transplant in Relapsed Multiple Myeloma
Data Collection
Blood Protein Disorders+11
+ Cardiovascular Diseases
+ Hematologic Diseases
Treatment Study
Summary
Study start date: September 1, 2003
Actual date on which the first participant was enrolled.This study will induce anti-myeloma responses in patients with high risk or relapsed myeloma using combination chemo- and immunotherapy comprising sequentially: 1) lymphoid suppressive conditioning to avoid rejection of the donor NK cells, 2) adoptive transfer of purified KIR-ligand mismatched Natural Killer cells from a haplo-identical donor, and 3) autografting two weeks after infusion of NK cells to ensure autologous reconstitution.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.10 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location