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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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CLINICAL TRIALS AND OBSERVATIONS
Thalidomide, dexamethasone, and pegylated liposomal doxorubicin (ThaDD) for patients older than 65 years with newly diagnosed multiple myeloma
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
From the Clinica di Ematologia Polo Ospedaliero-Universitario, Ospedali Riuniti Ancona Università Politecnica delle Marche, Ancona, Italy; Divisione Medicina, Ospedale Santa Croce, Fano, Italy; Divisione Ematologia, Ospedale San Salvatore, Pesaro, Italy; Unità Oncoematologica, Ospedale Bartolomeo Eustacchio, San Severino Marche, Italy; Divisione Ematologia, Ospedale Mazzoni, Ascoli Piceno, Italy; Divisione Medicina, Ospedale Generale Provinciale, Macerata, Italy; Divisione Medicina, Ospedali Riuniti Jesi, Jesi, Italy; Divisione Medicina, Ospedale Generale di Zona, Civitanova Marche, Italy; Divisione Medicina, Presidio Ospedaliero, Tolentino, Italy; Servizio Oncologia, Ospedale Stelluti Scala, Fabriano, Italy; and Divisione Medicina, Ospedale Stelluti Scala, Fabriano, Italy.
We present the results of a phase 2 study using thalidomide, dexamethasone, and pegylated liposomal doxorubicin (ThaDD) in the treatment of 50 patients older than 65 years with newly diagnosed multiple myeloma. Thalidomide 100 mg was administered orally at bedtime continuously, dexamethasone 40 mg was administered orally on days 1 to 4 and 9 to 12, and pegylated liposomal doxorubicin 40 mg/m2 was administered intravenously on day 1 over the 28-day 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 1 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 of at least VGPR versus those who did not. Grade 3 and 4 nonhematologic adverse events were constipation (10%), fatigue (6%), tremors (4%), mucositis (4%), and palmar-plantar erythrodysesthesia (2%). Grade 3 and 4 neutropenia occurred in 12% of patients. Grade 3 and 4 infections and thromboembolic 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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