Haematologica 2003 - Supplements

Conclusion: Only the thalidomide 200mg arm of this trial met our
definition of a tolerable maintenance therapy i.e. no dose
reductions or discontinuation in at least 65% of patients for a
minimum of 6 months. This regimen has therefore been selected
for further study in a Phase III randomized trial.
10.2 Conditioning regimens, stem cell collection,
toxicity and immune reconstitution
273
TWO DOSE-INTENSIVE MELPHALAN REGIMENS (100
mg/m2 versus 200 mg/m2) IN MULTIPLE MYELOMA
PATIENTS.
A. Palumbo, S. Bringhen, A. Bertola, F. Cavallo, P. Falco,
M. Massaia, B. Bruno, A. Barbui$, T. Caravita*, P. Musto§,
N. Pescosta°, F. Rossini^, M. Vignetti# and M. Boccadoro.
Divisione di Ematologia dell'Università di Torino, Azienda
Ospedaliera S. Giovanni Battista, Torino, Italy; $Divisione di
Ematologia, Ospedali Riuniti, Bergamo, Italy; *Cattedra di
Ematologia, Policlinico S. Eugenio, Roma, Italy; §Dipartimento di
Onco-Ematologia, IRCCS, Casa Sollievo della Sofferenza, S.
Giovanni Rotondo, Foggia, Italy; °Ospedale Lorenz B:Ohler,
Bolzano, Italy; ^Istituto Scienze Biomediche, Cattedra di
Semeiotica Medica, Monza, Italy; # Cattedra di Ematologia,
Università Cattolica S. Cuore, Roma; Italy
In multiple myeloma the superiority of high-dose melphalan
(usually 200 mg/m2, MEL200) followed by stem cell support
versus standard therapy has been showed in several trials. It
increases complete remission (CR) rate, extends event-free
survival (EFS), and overall survival (OS) from 3 to 5 years. The
median age for transplanted patients ranged from 49 to 52 years
in the major clinical trials. Recently the clinical impact of
intermediate dose-intensive melphalan has been evaluated.
Melphalan 60 mg/m2 was superior to melphalan 30 mg/m2 in
refractory patients. Melphalan 100 mg/m2 (MEL100) was
superior to standard oral melphalan and prednisone in newly
diagnosed patients. In both studies, the median age was 63-64
years, health-care support was similar to that required for
intravenous conventional chemotherapy.
Both MEL100 and MEL200 are clearly superior to standard-dose
melphalan, however their comparative toxicities and outcomes
are unclear. In this study we treated patients with similar disease
characteristics with MEL100 or MEL200: their toxicities and
outcomes were compared.
Ninety patients at diagnosis were treated with two MEL100
courses between 1994 and 2001. The clinical outcome was
compared with a control group of 90 pair mates matched for
serum microglobulin levels and Durie and Salmon clinical
stage. These patients were treated at diagnosis with MEL200
courses.
Clinical characteristics were similar in both groups except for age
that was significantly different (p< 0.001). Transplant-related
mortality was 4% after MEL100 and 5% after MEL200 (p=NS).
Complete remission (CR) was 35% after MEL100, 48% after
MEL200 (p =0.08). Median event-free survival (EFS) was 32
months in the MEL100 group, 42 months in the MEL200 group
(p