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 & 2 others Monica Marconi, Pietro Leoni

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Abstract

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.

Original languageEnglish
Pages (from-to)2159-2164
Number of pages6
JournalBlood
Volume108
Issue number7
DOIs
Publication statusPublished - Oct 1 2006

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Thalidomide
Multiple Myeloma
Dexamethasone
Toxicity
Accidents
Disease-Free Survival
Fatigue of materials
Mucositis
Tremor
Constipation
liposomal doxorubicin
Neutropenia
Fatigue
Survival
Therapeutics
Infection

ASJC Scopus subject areas

  • Hematology

Cite this

Offidani, M., Corvatta, L., Piersantelli, M. N., Visani, G., Alesiani, F., Brunori, M., ... Leoni, P. (2006). Thalidomide, dexamethasone, and pegylated liposomal doxorubicin (ThaDD) for patients older than 65 years with newly diagnosed multiple myeloma. Blood, 108(7), 2159-2164. https://doi.org/10.1182/blood-2006-03-013086

Thalidomide, dexamethasone, and pegylated liposomal doxorubicin (ThaDD) for patients older than 65 years with newly diagnosed multiple myeloma. / Offidani, Massimo; Corvatta, Laura; Piersantelli, Maria Novella; Visani, Giuseppe; Alesiani, Francesco; Brunori, Marino; Galieni, Piero; Catarini, Massimo; Burattini, Maurizio; Centurioni, Riccardo; Ferranti, Mario; Rupoli, Serena; Scortechini, Anna Rita; Giuliodori, Luciano; Candela, Marco; Capelli, Debora; Montanari, Mauro; Olivieri, Attilio; Poloni, Antonella; Polloni, Claudia; Marconi, Monica; Leoni, Pietro.

In: Blood, Vol. 108, No. 7, 01.10.2006, p. 2159-2164.

Research output: Contribution to journalArticle

Offidani, M, Corvatta, L, Piersantelli, MN, Visani, G, Alesiani, F, Brunori, M, Galieni, P, Catarini, M, Burattini, M, Centurioni, R, Ferranti, M, Rupoli, S, Scortechini, AR, Giuliodori, L, Candela, M, Capelli, D, Montanari, M, Olivieri, A, Poloni, A, Polloni, C, Marconi, M & Leoni, P 2006, 'Thalidomide, dexamethasone, and pegylated liposomal doxorubicin (ThaDD) for patients older than 65 years with newly diagnosed multiple myeloma', Blood, vol. 108, no. 7, pp. 2159-2164. https://doi.org/10.1182/blood-2006-03-013086
Offidani, Massimo ; Corvatta, Laura ; Piersantelli, Maria Novella ; Visani, Giuseppe ; Alesiani, Francesco ; Brunori, Marino ; Galieni, Piero ; Catarini, Massimo ; Burattini, Maurizio ; Centurioni, Riccardo ; Ferranti, Mario ; Rupoli, Serena ; Scortechini, Anna Rita ; Giuliodori, Luciano ; Candela, Marco ; Capelli, Debora ; Montanari, Mauro ; Olivieri, Attilio ; Poloni, Antonella ; Polloni, Claudia ; Marconi, Monica ; Leoni, Pietro. / Thalidomide, dexamethasone, and pegylated liposomal doxorubicin (ThaDD) for patients older than 65 years with newly diagnosed multiple myeloma. In: Blood. 2006 ; Vol. 108, No. 7. pp. 2159-2164.
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AU - Visani, Giuseppe

AU - Alesiani, Francesco

AU - Brunori, Marino

AU - Galieni, Piero

AU - Catarini, Massimo

AU - Burattini, Maurizio

AU - Centurioni, Riccardo

AU - Ferranti, Mario

AU - Rupoli, Serena

AU - Scortechini, Anna Rita

AU - Giuliodori, Luciano

AU - Candela, Marco

AU - Capelli, Debora

AU - Montanari, Mauro

AU - Olivieri, Attilio

AU - Poloni, Antonella

AU - Polloni, Claudia

AU - Marconi, Monica

AU - Leoni, Pietro

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N2 - 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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