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Blood, Vol. 92 No. 9 (November 1), 1998:
pp. 3131-3136
High-Dose Therapy and Autologous Peripheral Blood Stem Cell
Transplantation in Multiple Myeloma: Up-front or Rescue Treatment?
Results of a Multicenter Sequential Randomized Clinical Trial
Jean-Paul Fermand,
Philippe Ravaud,
Sylvie Chevret,
Marine Divine,
Véronique Leblond,
Coralie Belanger,
Margaret Macro,
Edouard Pertuiset,
François Dreyfus,
Xavier Mariette,
Catherine Boccacio, and
Jean-Claude Brouet for the Group "Myélome
Autogreffe"*
From the Immuno-Haematology Unit and the Department of Biostatistics,
Hôpital Saint Louis, Paris; The Rheumatology and Haematology
Units, Hôpital Cochin, Paris; the Haematology Unit, Hôpital
Henri Mondor, Creteil; the Haematology Unit and the Department of
Haemobiology, Hôpital Pitié-Salpétrière, Paris;
the Haematology Unit, Hôpital Necker, Paris; the Rheumatology
Unit, Hôpital Lariboisière, Paris; and the Haematology
Unit, Centre Hospitalier, Caen, France.
Results to date indicate that high-dose therapy (HDT) with
autologous stem cell support improves survival of patients with symptomatic multiple myeloma (MM). We performed a multicenter, sequential, randomized trial designed to assess the optimal timing of
HDT and autotransplantation. Among 202 enrolled patients who were up to
56 years old, 185 were randomly assigned to receive HDT and peripheral
blood stem cell (PBSC) autotransplantation (early HDT group, n = 91)
or a conventional-dose chemotherapy (CCT) regimen (late HDT group, n
= 94). In the late HDT group, HDT and transplantation were performed
as rescue treament, in case of primary resistance to CCT or at relapse
in responders. PBSC were collected before randomization, after
mobilization by chemotherapy, and, in the two groups, HDT was preceded
by three or four treatments with vincristine, doxorubicin, and
methylprednisolone. Data were analyzed on an
intent-to-treat basis using a sequential design. Within a median
follow-up of 58 months, estimated median overall survival (OS) was 64.6 months in the early HDT group and 64 months in the late group. Survival
curves were not different (P = .92, log-rank test). Median
event-free survival (EFS) was 39 months in the early HDT group whereas
median time between randomization and CCT failure was 13 months in the
late group. Average time without symptoms, treatment, and treatment
toxicity (TWiSTT) were 27.8 months (95% confidence interval [CI];
range, 23.8 to 31.8) and 22.3 months (range, 16.0 to 28.6)
in the two groups, respectively. HDT with PBSC transplantation obtained
a median OS exceeding 5 years in young patients with symptomatic MM,
whether performed early, as first-line therapy, or late, as rescue
treatment. Early HDT may be preferred because it is associated with a
shorter period of chemotherapy.
© 1998 by The American Society of Hematology.
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