Study of KIR-Ligand Mismatched Haplo-Identical Natural Killer Cells Transfused Before Autologous Stem Cell Transplant
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 suppressive conditioning, 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. Other objectives include establishing the response rate, disease free survival, progression free survival and toxicity of regimen. Secondary objectives are to monitor the persistence of haplo-identical purified KIR-ligand mismatched Natural Killer cells by molecular methods, select haplo-identical purified KIR-ligand mismatched donors and predict prior to therapy which donor will induce a response, monitor Natural Killer cell reconstitution prior to and after autografting, and establish Natural Killer cell clones after autografting and determine origin and specificity.
Timeline
- Start
- 2003-09
- Primary completion
- 2010-05
- Completion
- 2010-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Background | Bortezomide | Unknown | 1 mg/m2 | — |
| Background | Cyclophosphamide | Other / unclassified | 60 mg/kg | Intravenous |
| Background | Dexamethasone | Small molecule | 40 mg | — |
| Background | Fludarabine | Small molecule | 1 mg/m2 | — |
| Background | Melphalan | Small molecule | 140 mg/m2 | Intravenous |
| Background | aldesleukin | Protein / enzyme biologic | 3 iu | — |