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1. Prolonged 18FDG-PET negative complete remission in a heavily pretreated, elderly patient with diffuse large B cell lymphoma treated with lenalidomide, low dose dexamethasone, and colony stimulating factor (Rd-G).

Author

Musuraca G, Fattori PP, Ceccolini M, Cangini D, Giannini MB, Ronconi S, Matteucci F, Asioli S, and Amadori D

Subjects
Aged, Colony-Stimulating Factors administration & dosage, Dexamethasone administration & dosage, Female, Fluorodeoxyglucose F18, Humans, Lenalidomide, Positron-Emission Tomography methods, Radiopharmaceuticals, Thalidomide administration & dosage, Thalidomide analogs & derivatives, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Dexamethasone therapeutic use, Lymphoma, Large B-Cell, Diffuse diagnostic imaging, Lymphoma, Large B-Cell, Diffuse drug therapy
Abstract

Diffuse large B-cell lymphoma (DLBCL) is a common lymphoid malignancy among adults in the developed world and accounts for about a third of all patients newly diagnosed with non-Hodgkin lymphoma each year. The prognosis of patients with DLBCL has improved over the past 10 years since the advent of chemoimmunotherapy regimens such as R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone). However, a significant number of patients still experience disease relapse or progression after first or second line therapy, and ~40% of patients will die within 5 years. In particular, elderly patients and those ineligible for high-dose chemotherapy due to comorbidities require effective salvage treatment options with favorable toxicity profile. Several novel therapeutic approaches have been proposed for these patients including monoclonal antibodies, radioimmunotherapy, proteasome inhibitors, mTOR inhibitors, and the immunomodulatory drugs such as thalidomide and lenalidomide.

Published
2011
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2. Complete remission upon bortezomib-dexamethasone therapy in three heavily pretreated multiple myeloma patients relapsing after allogeneic stem cell transplantation.

Author

Tosi P, Zamagni E, Cangini D, Tacchetti P, Perrone G, Ceccolini M, Baccarani M, and Cavo M

Subjects
Adult, Aged, Bortezomib, Female, Humans, Male, Recurrence, Remission Induction, Salvage Therapy, Time Factors, Transplantation, Homologous, Anti-Inflammatory Agents administration & dosage, Boronic Acids administration & dosage, Dexamethasone administration & dosage, Graft Survival drug effects, Multiple Myeloma prevention & control, Protease Inhibitors administration & dosage, Pyrazines administration & dosage, Stem Cell Transplantation
Published
2006
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3. First-line therapy with thalidomide, dexamethasone and zoledronic acid decreases bone resorption markers in patients with multiple myeloma.

Author

Tosi P, Zamagni E, Cellini C, Parente R, Cangini D, Tacchetti P, Perrone G, Ceccolini M, Boni P, Tura S, Baccarani M, and Cavo M

Subjects
Adult, Aged, Alkaline Phosphatase blood, Alkaline Phosphatase urine, Amino Acids blood, Amino Acids urine, Antineoplastic Combined Chemotherapy Protocols pharmacology, Biomarkers urine, Bone Remodeling drug effects, Bone Resorption metabolism, Collagen Type I blood, Collagen Type I urine, Female, Humans, Male, Middle Aged, Multiple Myeloma diagnosis, Multiple Myeloma metabolism, Osteocalcin metabolism, Pain drug therapy, Peptides blood, Peptides urine, Treatment Outcome, Zoledronic Acid, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Biomarkers blood, Bone Resorption drug therapy, Dexamethasone administration & dosage, Diphosphonates administration & dosage, Imidazoles administration & dosage, Multiple Myeloma drug therapy, Thalidomide administration & dosage
Abstract

Background: Bone involvement is frequently observed in multiple myeloma (MM) patients both at diagnosis and during the course of the disease. The evaluation of biochemical markers of bone turnover could allow a dynamic evaluation of the effects of a given therapy on bone metabolism., Methods: In the present study, markers of bone resorption [urinary free pyridinoline (PYD), deoxypyridinoline (DPYD), N-terminal telopeptide of collagen I (NTX) and C-terminal telopeptide (serum crosslaps)] and of bone formation [bone alkaline phosphatase (BAP) and osteocalcin] were evaluated at diagnosis and after induction therapy in 40 patients (23M, 17F, median age = 53.5 yr) enrolled in the 'Bologna 2002' clinical trial. By study design, all patients received 4 months of combined thalidomide (100 mg/d for 2 wk then 200 mg/d), dexamethasone (40 mg/d on days 1-4, 9-12, 17-20/28 on odd cycles and on days 1-4 on even cycles) and zoledronic acid (4 mg/28 d)., Results: At diagnosis, although bone resorption markers were increased in more than 40% of the patients, only NTX (P = 0.029) and crosslaps (P = 0.000) were significantly related to the extent of skeletal lesions, as assessed by X-ray. After 4 months of therapy, a significant decrease in mean (+/-SE) urinary NTX (52.7 +/-6.9 nmol/mmol creatinine +/-6.9 vs. 14 +/- 1.42 nmol/mmol creatinine, P = 0.000) and serum crosslaps (6242.4 +/-945 pmol/L vs. 1414.9 +/- 173.8 pmol/L, P = 0.000) was observed in patients obtaining > or =partial response, at variance to what has been detected in patients showing

Published
2006
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4. Superiority of thalidomide and dexamethasone over vincristine-doxorubicindexamethasone (VAD) as primary therapy in preparation for autologous transplantation for multiple myeloma.

Author

Cavo M, Zamagni E, Tosi P, Tacchetti P, Cellini C, Cangini D, de Vivo A, Testoni N, Nicci C, Terragna C, Grafone T, Perrone G, Ceccolini M, Tura S, and Baccarani M

Subjects
Anti-Inflammatory Agents adverse effects, Antineoplastic Combined Chemotherapy Protocols adverse effects, Case-Control Studies, Dexamethasone adverse effects, Doxorubicin adverse effects, Humans, Immunosuppressive Agents adverse effects, Middle Aged, Retrospective Studies, Thalidomide adverse effects, Vincristine adverse effects, Anti-Inflammatory Agents administration & dosage, Antineoplastic Combined Chemotherapy Protocols administration & dosage, Dexamethasone administration & dosage, Doxorubicin administration & dosage, Hematopoietic Stem Cell Transplantation, Immunosuppressive Agents administration & dosage, Multiple Myeloma therapy, Thalidomide administration & dosage, Vincristine administration & dosage
Abstract

The aim of the present study was to compare thalidomide-dexamethasone (Thal-Dex) and vincristine-doxorubicin-dexamethasone (VAD) as primary therapy in preparation for autologous peripheral blood stem-cell (PBSC) transplantation for multiple myeloma (MM). For this purpose, we performed a retrospective matched case-control analysis of 200 patients who entered 2 consecutive studies from 1996 to 2004 and received Thal-Dex (n = 100) or VAD (n = 100) administered for 4 months before collection of PBSCs and autologous transplantation. Matching criteria included age, clinical stage, and serum beta2-microglobulin levels. In comparison with VAD, Thal-Dex resulted in a significantly higher response rate (52% versus 76%, respectively; P < .001) and effected more profound reduction in myeloma cell mass of both immunoglobulin G (IgG; P = .02) and IgA (P = .03) type. More frequent toxicities included nonfatal deep vein thrombosis with Thal-Dex (15%) and granulocytopenia with VAD (12%). In each of the 2 treatment groups, 91% of patients proceeded to PBSC mobilization. The median number of collected CD34+ cells was 7.85 x 10(6)/kg in the Thal-Dex group and 10.5 x 10(6)/kg in the control group. Thal-Dex may be considered an effective and relatively well-tolerated oral alternative to the more complex VAD regimen as front-line therapy for MM patients who are candidates for subsequent autologous transplantation.

Published
2005
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5. First-line therapy with thalidomide and dexamethasone in preparation for autologous stem cell transplantation for multiple myeloma.

Author

Cavo M, Zamagni E, Tosi P, Cellini C, Cangini D, Tacchetti P, Testoni N, Tonelli M, de Vivo A, Palareti G, Tura S, and Baccarani M

Subjects
Adult, Aged, Antineoplastic Combined Chemotherapy Protocols adverse effects, Dexamethasone adverse effects, Humans, Middle Aged, Thalidomide adverse effects, Transplantation, Autologous, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Dexamethasone therapeutic use, Multiple Myeloma therapy, Peripheral Blood Stem Cell Transplantation, Thalidomide therapeutic use, Transplantation Conditioning
Abstract

Background and Objectives: The marked synergy of thalidomide and dexamethasone in advanced and refractory multiple myeloma (MM) provided the basis for a phase 2 clinical study aimed at investigating the efficacy and toxicity of this combination as first-line therapy for patients less than 65 years old with newly diagnosed disease., Design and Methods: Both thalidomide and dexamethasone were administered for 4 months in an attempt to reduce tumor cell mass before collection of peripheral blood stem cells (PBSC) and subsequent double autologous transplantation. Thalidomide was given at the fixed dose of 200 mg/day; dexamethasone was administered at the dose of 40 mg/day on days 1-4, 9-12 and 17- 20 in odd cycles and 40 mg/day on days 1-4 in even cycles, repeated monthly., Results: Seventy-one patients with symptomatic MM were evaluated for response and toxicity. On an intent-to-treat basis, the overall response (>or= partial remission) rate was 66%, including 17% of patients who attained a complete remission or a very good partial remission. In addition to common toxicity of thalidomide, deep-vein thrombosis was a troublesome adverse event (16%). Nine patients (13%) required thalidomide discontinuation because of toxicity, including 3 patients who died during the study treatment. Fifty-nine patients proceeded to PBSC mobilization and yielded a median number of 7.1x10(6) CD 34(+ ) cells/kg., Interpretation and Conclusions: The combination of thalidomide and dexamethasone is an effective and relatively well tolerated induction regimen for previously untreated patients with MM. This combination may provide an oral alternative to vincristine-doxorubicin-dexamethasone in preparation for autologous stem cell transplantation.

Published
2004

6. Cyclin D1 overexpression is a favorable prognostic variable for newly diagnosed multiple myeloma patients treated with high-dose chemotherapy and single or double autologous transplantation.

Author

Soverini S, Cavo M, Cellini C, Terragna C, Zamagni E, Ruggeri D, Testoni N, Tosi P, De Vivo A, Amabile M, Grafone T, Ottaviani E, Giannini B, Cangini D, Bonifazi F, Neri A, Fabris S, Tura S, Baccarani M, and Martinelli G

Subjects
Adult, Antineoplastic Agents, Alkylating administration & dosage, Chromosome Aberrations, Chromosomes, Human, Pair 11, Chromosomes, Human, Pair 13, Combined Modality Therapy, Cyclophosphamide administration & dosage, Disease-Free Survival, Female, Gene Expression, Humans, Male, Melphalan administration & dosage, Middle Aged, Predictive Value of Tests, Prognosis, Reproducibility of Results, Reverse Transcriptase Polymerase Chain Reaction standards, Sensitivity and Specificity, Antineoplastic Combined Chemotherapy Protocols administration & dosage, Cyclin D1 genetics, Dexamethasone administration & dosage, Doxorubicin administration & dosage, Hematopoietic Stem Cell Transplantation, Multiple Myeloma diagnosis, Multiple Myeloma drug therapy, Multiple Myeloma genetics, Vincristine administration & dosage
Abstract

We used a sensitive real-time reverse transcription-polymerase chain reaction assay to quantify cyclin D1 mRNA levels in bone marrow samples collected at diagnosis from 74 newly diagnosed multiple myeloma (MM) patients who were randomized to undergo either single or double autologous peripheral blood stem cell transplantation as part of first-line therapy for their malignancy. In 46 cases, fluorescence in situ hybridization (FISH) analysis and/or conventional cytogenetics were performed to detect chromosome 11 abnormalities. Patients with the t(11;14) or trisomy 11 significantly overexpressed cyclin D1 (P <.0001) in comparison with patients without 11q abnormalities, who had cyclin D1 mRNA levels similar to healthy donors. Overall, 32 (43%) of 74 patients showed cyclin D1 overexpression. No difference was found between cyclin D1-positive (group A) and cyclin D1-negative (group B) patients with respect to presenting clinical and laboratory characteristics, including chromosome 13 abnormalities, as well as to response to therapy and overall survival, both of which were calculated on an intent-to-treat basis. Patients who overexpressed cyclin D1 had significantly longer duration of remission in comparison with patients who did not (41 vs 26 months, respectively; P =.02). As a result, median event-free survival (EFS) was longer in group A than in group B (33 vs 24 months, respectively; P =.055). We concluded that cyclin D1 overexpression is closely associated with 11q abnormalities and identifies a subset of MM patients who are more likely to have prolonged duration of remission and EFS following autologous transplantation.

Published
2003
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7. Bortezomib-thalidomide-dexamethasone is superior to thalidomide-dexamethasone as consolidation therapy following autologous hematopoietic stem-cell transplantation in patients with newly diagnosed multiple myeloma

Author

Cavo, Michele, Pantani, Lucia, Petrucci, Maria Teresa, Patriarca, Francesca, Zamagni, Elena, Donnarumma, Daniela, Crippa, Claudia, Boccadoro, Mario, Perrone, Giulia, Falcone, Antonietta, Nozzoli, Chiara, Zambello, Renato, Masini, Luciano, Furlan, Anna, Brioli, Annamaria, Derudas, Daniele, Ballanti, Stelvio, Dessanti, Maria Laura, De Stefano, Valerio, Carella, Angelo Michele, Marcatti, Magda, Nozza, Andrea, Ferrara, Felicetto, Callea, Vincenzo, Califano, Catello, Pezzi, Annalisa, Baraldi, Anna, Grasso, Mariella, Musto, Pellegrino, Palumbo, Antonio COLLABORATORI: Tosi, P, Motta, Mr, Rizzi, S, Fanin, R, Buttignol, S, Foà, R, Levi, A, Calabrese, E, Rambaldi, A, Galli, M, Rossi, G, Ferrari, S, Bringhen, S, Leoni, P, Offidani, M, Polloni, C, Corradini, P, Montefusco, V, Torelli, G, Narni, Franco, Fioritoni, G, Spadano, A, Cortelazzo, S, Pescosta, N, Billio, A, Lambertenghi Deliliers, G, Baldini, L, Onida, F, Annaloro, C, La Nasa, G, Ledda, A, Zaccaria, A, Cellini, C, De Fabritiis, P, Caravita, T, Siniscalchi, A, Cascavilla, N, Bosi, A, Semenzato, G, Gugliotta, L, Merli, F, Gherlinzoni, F, Angelucci, E, Martelli, M, Petti, Mc, Pisani, F, Leone, G, Rossi, E, Za, T, Fianchi, L, Catania, G, Spriano, M, Ciceri, F, Peccatori, J, Girlanda, S, Santoro, A, Castagna, L, Palmieri, S, Nobile, F, D'Arco, Am, Levis, A, Primon, V, Tamiazzo, S, Guardigni, L, Pasini, S, Gallamini, A, Pietrantuono, G, Martorelli, Mc, Fattori, P, Pasquini, E, Galieni, P, Ruggieri, M, Morandi, S, Tajana, M, Amadori, D, Ronconi, S, Cangini, D, Ceccolini, M, Gobbi, M, Ballerini, F, Pane, F, Catalano, L, Cangialosi, C, Vallisa, D, Lazzaro, A, Paladini, G, De Sabbata, G, Mozzana, R, Ciambelli, F, Pinotti, G, Rodeghiero, F, Elice, F, Cantore, N, Volpe, S, Pavone, V, Mele, A, Pogliani, E, Rossini, F, Liberati, A, Majolino, I, De Rosa, L, Amadori, S, Rizzo, M, Lauria, F, Gozzetti, A, Aglietta, M, Capaldi, A, Quarta, G, Mele, G, Storti, S, Fraticelli, V, Morabito, F, Gentile, C, Capalbo, S, Gianni, A, Magni, M, Mettivier, V, Nunziata, G, Rizzoli, V, Giuliani, N, Crugnola, M, Bernasconi, C, Fregoni, V, Visani, G, Olivieri, A, Pizzuti, M, La Verde, G, Moscetti, A, Avvisati, G, Tirindelli, M, Longinotti, M, Podda, L, Gallo, E, Pregno, P, Dammacco, F, Perosa, F, Russo, D, Roccaro, A, Bacigalupo, A, Dominietto, A, Musolino, C, Quartarone, E., Cavo M, Pantani L, Petrucci MT, Patriarca F, Zamagni E, Donnarumma D, Crippa C, Boccadoro M, Perrone G, Falcone A, Nozzoli C, Zambello R, Masini L, Furlan A, Brioli A, Derudas D, Ballanti S, Dessanti ML, De Stefano V, Carella AM, Marcatti M, Nozza A, Ferrara F, Callea V, Califano C, Pezzi A, Baraldi A, Grasso M, Musto P, Palumbo A., Cavo, Michele, Pantani, Lucia, Petrucci, Maria Teresa, Patriarca, Francesca, Zamagni, Elena, Donnarumma, Daniela, Crippa, Claudia, Boccadoro, Mario, Perrone, Giulia, Falcone, Antonietta, Nozzoli, Chiara, Zambello, Renato, Masini, Luciano, Furlan, Anna, Brioli, Annamaria, Derudas, Daniele, Ballanti, Stelvio, Dessanti, Maria Laura, De Stefano, Valerio, Carella, Angelo Michele, Marcatti, Magda, Nozza, Andrea, Ferrara, Felicetto, Callea, Vincenzo, Califano, Catello, Pezzi, Annalisa, Baraldi, Anna, Grasso, Mariella, Musto, Pellegrino, Palumbo, Antonio, Cavo, M, Pantani, L, Petrucci, M, Patriarca, F, Zamagni, E, Donnarumma, D, Crippa, C, Boccadoro, M, Perrone, G, Falcone, A, Nozzoli, C, Zambello, R, Masini, L, Furlan, A, Brioli, A, Derudas, D, Ballanti, S, Dessanti, M, De Stefano, V, Carella, A, Marcatti, M, Nozza, A, Ferrara, F, Callea, V, Califano, C, Pezzi, A, Baraldi, A, Grasso, M, Musto, P, Palumbo, A, Tosi, P, Motta, M, Rizzi, S, Fanin, R, Buttignol, S, Foà, R, Levi, A, Calabrese, E, Rambaldi, A, Galli, M, Rossi, G, Ferrari, S, Bringhen, S, Leoni, P, Offidani, M, Polloni, C, Corradini, P, Montefusco, V, Torelli, G, Narni, F, Fioritoni, G, Spadano, A, Cortelazzo, S, Pescosta, N, Billio, A, Lambertenghi Deliliers, G, Baldini, L, Onida, F, Annaloro, C, La Nasa, G, Ledda, A, Zaccaria, A, Cellini, C, De Fabritiis, P, Caravita, T, Siniscalchi, A, Cascavilla, N, Bosi, A, Semenzato, G, Gugliotta, L, Merli, F, Gherlinzoni, F, Angelucci, E, Martelli, M, Petti, M, Pisani, F, Leone, G, Rossi, E, Za, T, Fianchi, L, Catania, G, Spriano, M, Ciceri, F, Peccatori, J, Girlanda, S, Santoro, A, Castagna, L, Palmieri, S, Nobile, F, D'Arco, A, Levis, A, Primon, V, Tamiazzo, S, Guardigni, L, Pasini, S, Gallamini, A, Pietrantuono, G, Martorelli, M, Fattori, P, Pasquini, E, Galieni, P, Ruggieri, M, Morandi, S, Tajana, M, Amadori, D, Ronconi, S, Cangini, D, Ceccolini, M, Gobbi, M, Ballerini, F, Pane, F, Catalano, L, Cangialosi, C, Vallisa, D, Lazzaro, A, Paladini, G, De Sabbata, G, Mozzana, R, Ciambelli, F, Pinotti, G, Rodeghiero, F, Elice, F, Cantore, N, Volpe, S, Pavone, V, Mele, A, Pogliani, E, Rossini, F, Liberati, A, Majolino, I, De Rosa, L, Amadori, S, Rizzo, M, Lauria, F, Gozzetti, A, Aglietta, M, Capaldi, A, Quarta, G, Mele, G, Storti, S, Fraticelli, V, Morabito, F, Gentile, C, Capalbo, S, Gianni, A, Magni, M, Mettivier, V, Nunziata, G, Rizzoli, V, Giuliani, N, Crugnola, M, Bernasconi, C, Fregoni, V, Visani, G, Olivieri, A, Pizzuti, M, La Verde, G, Moscetti, A, Avvisati, G, Tirindelli, M, Longinotti, M, Podda, L, Gallo, E, Pregno, P, Dammacco, F, Perosa, F, Russo, D, Roccaro, A, Bacigalupo, A, Dominietto, A, Musolino, C, and Quartarone, E

Subjects
Male, Boronic Acid, medicine.medical_treatment, PLUS DEXAMETHASONE, Phases of clinical research, Kaplan-Meier Estimate, Hematopoietic stem cell transplantation, Biochemistry, Antineoplastic Agent, Bortezomib-thalidomide-dexamethasone, Bortezomib, Immunosuppressive Agent, Autologous stem-cell transplantation, MULTIPLE MYELOMA, Antineoplastic Combined Chemotherapy Protocols, thalidomide-dexamethasone, Multiple myeloma, RANDOMIZED PHASE-3, LENALIDOMIDE, STEM CELL TRANSPLANTATION, Hematopoietic Stem Cell Transplantation, PHASE-III TRIAL, Hematology, Middle Aged, CHEMOTHERAPY, Prognosis, Boronic Acids, Combined Modality Therapy, Thalidomide, Transplantation, Autologou, Pyrazines, HIGH-DOSE MELPHALAN, INDUCTION TREATMENT, Female, Autologous, Immunosuppressive Agents, Pyrazine, Human, medicine.drug, MAINTENANCE THERAPY, medicine.medical_specialty, DOXORUBICIN, Antineoplastic Agents, Hormonal, Prognosi, Immunology, Urology, Antineoplastic Agents, dexamethasone, Transplantation, Autologous, Disease-Free Survival, Dexamethasone, Humans, Multiple Myeloma, Cell Biology, medicine, Autologous transplantation, METAANALYSIS, Transplantation, Antineoplastic Combined Chemotherapy Protocol, Hormonal, business.industry, medicine.disease, Surgery, business, Settore MED/15 - Malattie del Sangue
Abstract

In a randomized, phase 3 study, superior complete/near-complete response (CR/nCR) rates and extended progression-free survival were demonstrated with bortezomib-thalidomide-dexamethasone (VTD) versus thalidomide-dexamethasone (TD) as induction therapy before, and consolidation after, double autologous stem cell transplantation for newly diagnosed myeloma patients (intention-to-treat analysis; VTD, n = 236; TD, n = 238). This per-protocol analysis (VTD, n = 160; TD, n = 161) specifically assessed the efficacy and safety of consolidation with VTD or TD. Before starting consolidation, CR/nCR rates were not significantly different in the VTD (63.1%) and TD arms (54.7%). After consolidation, CR (60.6% vs 46.6%) and CR/nCR (73.1% vs 60.9%) rates were significantly higher for VTD-treated versus TD-treated patients. VTD consolidation significantly increased CR and CR/nCR rates, but TD did not (McNemar test). With a median follow-up of 30.4 months from start of consolidation, 3-year progression-free survival was significantly longer for the VTD group (60% vs 48% for TD). Grade 2 or 3 peripheral neuropathy (8.1% vs 2.4%) was more frequent with VTD (grade 3, 0.6%) versus TD consolidation. The superior efficacy of VTD versus TD as induction was retained despite readministration as consolidation therapy after double autologous transplantation. VTD consolidation therapy significantly contributed to improved clinical outcomes observed for patients randomly assigned to the VTD arm of the study. The study is registered at www.clinicaltrials.gov as #NCT01134484.

Published
2012

8. Neurological toxicity of long-term (>1 yr) thalidomide therapy in patients with multiple myeloma

Author

Delia Cangini, Patrizia Tosi, R. Plasmati, Sante Tura, Michele Cavo, Francesca Pastorelli, Michele Baccarani, Giulia Perrone, Elena Zamagni, Paola Tacchetti, Claudia Cellini, TOSI P, ZAMAGNI E, CELLINI C, PLASMATI R, CANGINI D, TACCHETTI P, PERRONE, PASTORELLI F, TURA S, BACCARANI M., and CAVO M.

Subjects
Adult, Male, medicine.medical_specialty, Peripheral neuropathy, Salvage therapy, Gastroenterology, Dexamethasone, Internal medicine, Antineoplastic Combined Chemotherapy Protocols, medicine, Humans, Longitudinal Studies, Multiple myeloma, Aged, Salvage Therapy, Dose-Response Relationship, Drug, Electromyography, business.industry, Incidence, Neurotoxicity, Peripheral Nervous System Diseases, Hematology, General Medicine, Middle Aged, medicine.disease, Thalidomide, Surgery, Clinical trial, Toxicity, Female, Neurotoxicity Syndromes, Multiple Myeloma, business, medicine.drug
Abstract

Objective Thalidomide is remarkably active in advanced relapsed and refractory multiple myeloma (MM), so that its use has been recently proposed either in newly diagnosed patients or as maintenance treatment after conventional or high-dose therapy. This latter therapeutic approach has risen the concern of side-effects of long-term therapy with this drug. Methods We analysed long-term toxicity of 40 patients (27 M, 13 F, median age = 61.5 yr) who received salvage therapy with thalidomide +/- dexamethasone for longer than 12 months (median 15, range 12-44) at our centre. All the patients had achieved at least a stable disease upon treatment with thalidomide alone (200-400 mg/d, n = 20) or thalidomide (200 mg/d) and dexamethasone (40 mg/d for 4 d every 4 wk) (n = 20). Results and conclusions Neurotoxicity was the most troublesome and frequent toxic effect that was observed after long-term treatment, the incidence averaging 75%. Among these 30 patients symptoms included paraesthesias, tremor and dizziness. Neurotoxicity was grade 1 in six patients (15%); grade 2 in 13 patients (32.5%), thus determining thalidomide dose reduction to 100 mg/d; and grade 3 in 11 patients (27.5%) who had subsequently to interrupt therapy despite their response. Electromyographic study, performed in patients with grade >/=2 neurotoxicity, revealed a symmetrical, mainly sensory peripheral neuropathy, with minor motor involvement. The severity of neurotoxicity was not related to cumulative or daily thalidomide dose, but only to the duration of the disease prior to thalidomide treatment, although no patients presented neurological symptoms at study entry. These results suggest that long-term thalidomide therapy in MM may be hampered by the remarkable neurotoxicity of the drug, and that a neurological evaluation should be mandatory prior to thalidomide treatment, in order to identify patients at risk of developing a peripheral neuropathy.

Published
2005

9. Prospective, randomized study of single compared with double autologous stem-cell transplantation for multiple myeloma: Bologna 96 clinical study

Author

Michele Baccarani, Michele Cavo, Sante Tura, Elena Zamagni, Affra Carubelli, Alessandro Gozzetti, Sonia Ronconi, Mauro Fiacchini, Patrizia Tosi, Antonio De Vivo, Delia Cangini, Antonio Lazzaro, Luciano Masini, Claudia Cellini, Ettore Volpe, Francesco Di Raimondo, Lucio Catalano, Francesca Patriarca, Franco Narni, Paola Tacchetti, Cavo M, Tosi P, Zamagni E, Cellini C, Tacchetti P, Patriarca F, Di Raimondo F, Volpe E, Ronconi S, Cangini D, Narni F, Carubelli A, Masini L, Catalano L, Fiacchini M, de Vivo A, Gozzetti A, Lazzaro A, Tura S, and Baccarani M.

Subjects
Melphalan, Male, medicine.medical_specialty, Cancer Research, Randomization, Cyclophosphamide, Urology, Kaplan-Meier Estimate, autologous, transplantation, myeloma, Transplantation, Autologous, Dexamethasone, Disease-Free Survival, law.invention, Antineoplastic Combined Chemotherapy Protocols, Doxorubicin, Female, Humans, Middle Aged, Multiple Myeloma, Stem Cell Transplantation, Vincristine, Oncology, Autologous stem-cell transplantation, Randomized controlled trial, law, Medicine, Multiple myeloma, Transplantation, business.industry, medicine.disease, Surgery, business, Autologous, Busulfan, medicine.drug
Abstract

Purpose We performed a prospective, randomized study of single (arm A) versus double (arm B) autologous stem-cell transplantation (ASCT) for younger patients with newly diagnosed multiple myeloma (MM). Patients and Methods A total of 321 patients were enrolled onto the study and were randomly assigned to receive either a single course of high-dose melphalan at 200 mg/m2 (arm A) or melphalan at 200 mg/m2 followed, after 3 to 6 months, by melphalan at 120 mg/m2 and busulfan at 12 mg/kilogram (arm B). Results As compared with assignment to the single-transplantation group (n = 163 patients), random assignment to receive double ASCT (n = 158 patients) significantly increased the probability to attain at least a near complete response (nCR; 33% v 47%, respectively; P = .008), prolonged relapse-free survival (RFS) duration of 18 months (median, 24 v 42 months, respectively; P < .001), and significantly extended event-free survival (EFS; median, 23 v 35 months, respectively; P = .001). Administration of a second transplantation and of novel agents for treating sequential relapses in up to 50% of patients randomly assigned to receive a single ASCT likely contributed to prolong the survival duration of the whole group, whose 7-year rate (46%) was similar to that of the double-transplantation group (43%; P = .90). Transplantation-related mortality was 3% in arm A and 4% in arm B (P = .70). Conclusion In comparison with a single ASCT as up-front therapy for newly diagnosed MM, double ASCT effected superior CR or nCR rate, RFS, and EFS, but failed to significantly prolong overall survival. Benefits offered by double ASCT were particularly evident among patients who failed at least nCR after one autotransplantation.

Published
2007

10. Complete remission upon bortezomib-dexamethasone therapy in three heavily pretreated multiple myeloma patients relapsing after allogeneic stem cell transplantation

Author

Patrizia Tosi, Delia Cangini, Paola Tacchetti, Michele Baccarani, Michela Ceccolini, Michele Cavo, Elena Zamagni, Giulia Perrone, Tosi P, Zamagni E, Cangini D, Tacchetti P, Perrone G, Ceccolini M, Baccarani M, and Cavo M.

Subjects
Adult, Male, Oncology, medicine.medical_specialty, Time Factors, Anti-Inflammatory Agents, Dexamethasone, Bortezomib, Text mining, Recurrence, Internal medicine, Humans, Transplantation, Homologous, Medicine, Protease Inhibitors, Multiple myeloma, Aged, Salvage Therapy, Hematology, business.industry, Graft Survival, Remission Induction, Complete remission, General Medicine, medicine.disease, Boronic Acids, Transplantation, Pyrazines, Female, Stem cell, Multiple Myeloma, business, Bortezomib/dexamethasone, Stem Cell Transplantation
Published
2006

11. Osteonecrosis of the jaws in newly diagnosed multiple myeloma patients treated with zoledronic acid and thalidomide-dexamethasone

Author

Massimo Offidani, Michele Cavo, Annamaria Brioli, Michela Ceccolini, Patrizia Tosi, Delia Cangini, Sonia Ronconi, Giulia Perrone, Alfonso Maria D'Arco, Elena Zamagni, Paola Tacchetti, Francesco Di Raimondo, Claudia Cellini, Michele Baccarani, Lucio Catalano, Sante Tura, Tosi P, Zamagni E, Cangini D, Tacchetti P, Di Raimondo F, Catalano L, D'ArcoA, Ronconi S, Cellini C, Offidani M, Perrone G, Ceccolini M, Brioli A, Tura S, Baccarani M, and Cavo M.

Subjects
medicine.medical_specialty, Bone disease, business.industry, Immunology, Retrospective cohort study, Cell Biology, Hematology, medicine.disease, Biochemistry, Gastroenterology, Surgery, Thalidomide, Pathogenesis, Zoledronic acid, Internal medicine, Medicine, business, Complication, Multiple myeloma, Dexamethasone, medicine.drug
Abstract

In recent years, an increasing number of reports have pointed out the association between osteonecrosis of the jaws (ONJ) and the use of bisphosphonates as therapy of neoplastic bone disease or benign osteoporosis.[1][1],[2][2] The pathogenesis of this complication is unknown, although

Published
2006

12. First-line therapy with thalidomide, dexamethasone and zoledronic acid decreases bone resorption markers in patients with multiple myeloma

Author

Raffaele Parente, Claudia Cellini, Delia Cangini, Sante Tura, Michela Ceccolini, Paola Tacchetti, Elena Zamagni, Michele Baccarani, Paola Boni, Giulia Perrone, Patrizia Tosi, Michele Cavo, Tosi P, Zamagni E, Cellini C, Parente R, Cangini D, Tacchetti P, Perrone G, Ceccolini M, Boni P, Tura S, Baccarani M, and Cavo M.

Subjects
Adult, Male, medicine.medical_specialty, Deoxypyridinoline, Osteocalcin, Pain, Zoledronic Acid, Bone resorption, Collagen Type I, Dexamethasone, Bone remodeling, chemistry.chemical_compound, N-terminal telopeptide, Internal medicine, Antineoplastic Combined Chemotherapy Protocols, medicine, Humans, Amino Acids, Bone Resorption, Multiple myeloma, Aged, biology, Diphosphonates, business.industry, Imidazoles, Hematology, General Medicine, Middle Aged, medicine.disease, Alkaline Phosphatase, Thalidomide, Endocrinology, Zoledronic acid, Treatment Outcome, chemistry, biology.protein, Female, Bone Remodeling, business, Multiple Myeloma, Peptides, Biomarkers, medicine.drug
Abstract

BACKGROUND Bone involvement is frequently observed in multiple myeloma (MM) patients both at diagnosis and during the course of the disease. The evaluation of biochemical markers of bone turnover could allow a dynamic evaluation of the effects of a given therapy on bone metabolism. METHODS In the present study, markers of bone resorption [urinary free pyridinoline (PYD), deoxypyridinoline (DPYD), N-terminal telopeptide of collagen I (NTX) and C-terminal telopeptide (serum crosslaps)] and of bone formation [bone alkaline phosphatase (BAP) and osteocalcin] were evaluated at diagnosis and after induction therapy in 40 patients (23M, 17F, median age = 53.5 yr) enrolled in the 'Bologna 2002' clinical trial. By study design, all patients received 4 months of combined thalidomide (100 mg/d for 2 wk then 200 mg/d), dexamethasone (40 mg/d on days 1-4, 9-12, 17-20/28 on odd cycles and on days 1-4 on even cycles) and zoledronic acid (4 mg/28 d). RESULTS At diagnosis, although bone resorption markers were increased in more than 40% of the patients, only NTX (P = 0.029) and crosslaps (P = 0.000) were significantly related to the extent of skeletal lesions, as assessed by X-ray. After 4 months of therapy, a significant decrease in mean (+/-SE) urinary NTX (52.7 +/-6.9 nmol/mmol creatinine +/-6.9 vs. 14 +/- 1.42 nmol/mmol creatinine, P = 0.000) and serum crosslaps (6242.4 +/-945 pmol/L vs. 1414.9 +/- 173.8 pmol/L, P = 0.000) was observed in patients obtaining > or =partial response, at variance to what has been detected in patients showing

Published
2006

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