Portal de Periódicos da CAPES

Multicenter phase III trial to evaluate CD34(+) selected versus unselected autologous peripheral blood progenitor cell transplantation in multiple myeloma.

1999; Elsevier BV; Volume: 93; Issue: 6 Linguagem: Inglês

10.1182/blood.v93.6.1858.406k06_1858_1868

1528-0020

Robert Vescio, Gary J. Schiller, A. Keith Stewart, Oscar Ballester, Stephen J. Noga, Hope S. Rugo, César O. Freytes, Edward A. Stadtmauer, Stefano Tarantolo, Firoozeh Sahebi, Pat Stiff, Jacinta Meharchard, Robert Schlossman, Randy A. Brown, Heather Tully, Mark Benyunes, Cindy Jacobs, Ronald Berenson, John F. DiPersio, K.M. Anderson, James R. Berenson,

Hematopoietic Stem Cell Transplantation

High-dose chemotherapy followed by autologous transplantation has been shown to improve response rates and survival in multiple myeloma and other malignancies. However, autografts frequently contain detectable tumor cells. Enrichment for stem cells using anti-CD34 antibodies has been shown to reduce autograft tumor contamination in phase I/II studies. To more definitively assess the safety and efficacy of CD34 selection, a phase III study was completed in 131 multiple myeloma patients randomized to receive an autologous transplant with either CD34-selected or unselected peripheral blood progenitor cells after myeloablative therapy. Tumor contamination in the autografts was assessed by a quantitative polymerase chain reaction detection assay using patient-specific, complementarity-determining region (CDR) Ig gene primers before and after CD34 selection. A median 3.1 log reduction in contaminating tumor cells was achieved in the CD34 selected product using the CEPRATE SC System (CellPro, Inc, Bothell, WA). Successful neutrophil engraftment was achieved in all patients by day 15 and no significant between-arm difference for time to platelet engraftment occurred in patients who received an infused dose of at least 2.0 × 106 CD34+ cells/kg. In conclusion, this phase III trial demonstrates that CD34-selection of peripheral blood progenitor cells significantly reduces tumor cell contamination yet provides safe and rapid hematologic recovery for patients receiving myeloablative therapy.