Status:
COMPLETED
Study of KIR-Ligand Mismatched Haplo-Identical Natural Killer Cells Transfused Before Autologous Stem Cell Transplant
Lead Sponsor:
University of Arkansas
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to induce anti-myeloma responses in patients with high risk or relapsed myeloma using combination chemo- and immunotherapy comprising sequentially: 1) lymphoid and myeloid...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00089453
Start Date
September 1 2003
End Date
May 1 2010
Last Update
April 19 2012
Active Locations (1)
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1
University of Arkansas for Medical Sciences/MIRT
Little Rock, Arkansas, United States, 72205