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Blood, 1 October 2006, Vol. 108, No. 7, pp. 2159-2164.
Prepublished online as a Blood First Edition Paper on June 8, 2006; DOI 10.1182/blood-2006-03-013086.
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Submitted March 28, 2006
Accepted May 17, 2006
Thalidomide, dexamethasone and pegylated liposomal doxorubicin (ThaDD) for newly diagnosed multiple myeloma patients over 65 years
Massimo Offidani*, Laura Corvatta, Maria-Novella Piersantelli, Giuseppe Visani, Francesco Alesiani, Marino Brunori, Piero Galieni, Massimo Catarini, Maurizio Burattini, Riccardo Centurioni, Mario Ferranti, Serena Rupoli, Anna Rita Scortechini, Luciano Giuliodori, Marco Candela, Debora Capelli, Mauro Montanari, Attilio Olivieri, Antonella Poloni, Claudia Polloni, Monica Marconi, and Pietro Leoni
Clinica di Ematologia
Divisione Medicina Fabriano
Clinica di Ematologia Polo Ospedaliero Universitario Ospedali Riuniti Universita Ancona
Divisione Ematologia Pesaro
Unita di Oncoematologia S, Severino Marche
Divisione Medicina Fano
Divisione di Ematologia Ascoli Piceno
Divisione Medicina Macerata
Divisione Medicina Jesi
Divisione Medicina Civitanova Marche
Divisione Medicina Tolentino
Servizio di Oncologia Fabriano
* Corresponding author; email: m.offidani{at}ao-umbertoprimo.marche.it.
We present the results of a phase II study using thalidomide, dexamethasone and pegylated liposomal doxorubicin (ThaDD) in the treatment of 50 newly diagnosed multiple myeloma patients over 65 years. Thalidomide was administered orally 100 mg at bedtime continuously, dexamethasone orally 40 mg days 1-4 and 9-12 and pegylated liposomal doxorubicin intravenously 40 mg/m2 on day 1 over the 28-days cycle. Response was assessed according to the EBMT criteria. Seventeen (34%) patients achieved CR, 7 (14%) nCR, 5 (10%) VGPR, 15 (30%) PR and 5 (10%) MR resulting in an ORR of 98%. Only one patient (2%) presented progressive disease. Time to progression (TTP), event-free survival (EFS) and overall survival (OS) projected at 3 years were 60%, 57% and 74% respectively, and these parameters were significantly higher in those patients achieving a response  VGPR versus those who did not. Grade 3-4 nonhematologic adverse events were constipation (10%), fatigue (6%), tremors (4%), mucositis (4%) and palmar-plantar erythro-dysesthesia (2%). Grade 3-4 neutropenia occurred in 12% of patients. Grade 3-4 infections and thrombo-embolic accidents were observed in 22% and 14% of patients, respectively. In the treatment of elderly patients with newly diagnosed multiple myeloma, ThaDD is a very effective regimen with manageable toxicity.
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