Haematologica 2003 - Supplements
Haematologica 2003 - Supplements
Haematologica 2003 - Supplements
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227<br />
MELPHALAN/PREDNISONE VS.<br />
MELPHALAN/DEXAMETASONE AS FIRST LINE<br />
TREATMENT IN ELDERLY MULTIPLE MYELOMA<br />
PATIENTS<br />
J.M.Hernández Martín, E.Golvano, R,García-Sanz,<br />
G.Mateo, J.Trujillo, F.J.Fdez-Calvo, J.A.Soler, S.Gardella,<br />
F.Carbonell, M.Fontanillas,J.Bladé, J.J.Sánchez,<br />
J.F.SanMiguel.<br />
PETHEMA Group<br />
Melphalan/Prednisone (MP) remains as the standard therapy for<br />
elderly Multiple Myeloma (MM) patients. High doses<br />
Dexametasone is one of the most active agents in MM. However,<br />
there aren’t controlled studies to explore the efficacy and safety<br />
of the combination of Dexamethasone with Melphalan.<br />
For this reason, the PETHEMA group (Spanish Program for the<br />
Therapeutic of Malign Hemopathies) designed a multicentric<br />
randomized study in order to compare if<br />
Melphalan/Dexametasone (MD) is superior to conventional MP.<br />
Response rates, event-free survival (EFS), survival and toxicity<br />
have been analyzed.<br />
MATHERIALS AND METHODS: Patients: 201 MM patients<br />
(proceeding of 27 Spanish Hospitals) > 65 year old or not<br />
candidates for autologous transplantation were included in the<br />
study. Patients were centrally randomized at diagnosis to receive<br />
6 courses of MP or MD (this with double pulse of<br />
Dexametasone). Patients who achieved any grade of response<br />
(Complete Response (CR), Partial Response (PR) or Minimal<br />
Response (MR) received six additional courses of the same<br />
schema; then, those achieving CR or PR went into maintenance<br />
therapy with Interpheron alfa-2b plus Dexametasone. Both arms<br />
were well balanced according to the most relevant clinicalbiologic<br />
disease characteristics. Median of follow-up was 46.8<br />
months. The study was approved for the local ethical committees<br />
RESULTS: In 27 cases (10 MP and 17 MD) there were lost of<br />
follow-up or major protocol violation. Although the overall<br />
response rate was similar in both arms after six courses (MP:<br />
65.4% vs. MD: 65%) (p=0.85) and after twelve courses (MP:<br />
46.1% vs. MD: 46.7%) (p=0.94), the proportion of CR was<br />
significantly higher in patients receiving MD than in those treated<br />
with MP, and this occurred both after six cycles (MP: 2.6% vs.<br />
MD: 9.3%) (p