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Blood, Vol. 93 No. 6 (March 15), 1999:
pp. 1858-1868
Multicenter Phase III Trial to Evaluate CD34+ Selected
Versus Unselected Autologous Peripheral Blood Progenitor Cell
Transplantation in Multiple Myeloma
Robert Vescio,
Gary Schiller,
A. Keith Stewart,
Oscar Ballester,
Stephen Noga,
Hope Rugo,
Cesar Freytes,
Edward Stadtmauer,
Stefano Tarantolo,
Firoozeh Sahebi,
Pat Stiff,
Jacinta Meharchard,
Robert Schlossman,
Randy Brown,
Heather Tully,
Mark Benyunes,
Cindy Jacobs,
Ronald Berenson,
John DiPersio,
Ken Anderson, and
James Berenson
From the West LA VAMC/University of California, Los
Angeles, Los Angeles, CA; The Toronto Hospital, Toronto, Ontario,
Canada; the University of South Florida, Miami, FL; Johns Hopkins
University, Baltimore, MD; the University of California, San Francisco,
San Francisco, CA; the University of Texas at San Antonio, San Antonio,
TX; the University of Pennsylvania, Philadelphia, PA; the University of
Nebraska, Omaha, NE; the Southern California Kaiser Permanente Medical
Group, Los Angeles, CA; Loyola University, Chicago, IL; the Washington
University School of Medicine, St Louis, MO; the Dana Farber Cancer
Institute, Boston, MA; and CellPro, Inc, Bothell, WA.
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.
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