24 results on '"Bosi, Alberto"'
Search Results
2. Daratumumab, bortezomib, and dexamethasone in relapsed or refractory multiple myeloma: subgroup analysis of CASTOR based on cytogenetic risk.
- Author
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Weisel K, Spencer A, Lentzsch S, Avet-Loiseau H, Mark TM, Spicka I, Masszi T, Lauri B, Levin MD, Bosi A, Hungria V, Cavo M, Lee JJ, Nooka A, Quach H, Munder M, Lee C, Barreto W, Corradini P, Min CK, Chanan-Khan AA, Horvath N, Capra M, Beksac M, Ovilla R, Jo JC, Shin HJ, Sonneveld P, Casneuf T, DeAngelis N, Amin H, Ukropec J, Kobos R, and Mateos MV
- Subjects
- Abnormal Karyotype, Adult, Aged, Aged, 80 and over, Antibodies, Monoclonal administration & dosage, Bortezomib administration & dosage, Dexamethasone administration & dosage, Female, Follow-Up Studies, Humans, In Situ Hybridization, Fluorescence, Kaplan-Meier Estimate, Male, Middle Aged, Multiple Myeloma genetics, Multiple Myeloma pathology, Neoplasm, Residual, Progression-Free Survival, Recurrence, Risk, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Multiple Myeloma drug therapy
- Abstract
Background: Multiple myeloma (MM) patients with high cytogenetic risk have poor outcomes. In CASTOR, daratumumab plus bortezomib/dexamethasone (D-Vd) prolonged progression-free survival (PFS) versus bortezomib/dexamethasone (Vd) alone and exhibited tolerability in patients with relapsed or refractory MM (RRMM)., Methods: This subgroup analysis evaluated D-Vd versus Vd in CASTOR based on cytogenetic risk, determined using fluorescence in situ hybridization and/or karyotype testing performed locally. High-risk patients had t(4;14), t(14;16), and/or del17p abnormalities. Minimal residual disease (MRD; 10
-5 sensitivity threshold) was assessed via the clonoSEQ® assay V2.0. Of the 498 patients randomized, 40 (16%) in the D-Vd group and 35 (14%) in the Vd group were categorized as high risk., Results: After a median follow-up of 40.0 months, D-Vd prolonged median PFS versus Vd in patients with standard (16.6 vs 6.6 months; HR, 0.26; 95% CI, 0.19-0.37; P < 0.0001) and high (12.6 vs 6.2 months; HR, 0.41; 95% CI, 0.21-0.83; P = 0.0106) cytogenetic risk. D-Vd achieved deep responses, including higher rates of MRD negativity and sustained MRD negativity versus Vd, regardless of cytogenetic risk. The safety profile was consistent with the overall population of CASTOR., Conclusion: These updated data reinforce the effectiveness and tolerability of daratumumab-based regimens for RRMM, regardless of cytogenetic risk status., Trial Registration: ClinicalTrials.gov, NCT02136134 . Registered 12 May 2014.- Published
- 2020
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3. Autologous stem cell transplantation is safe in selected elderly multiple myeloma patients.
- Author
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Antonioli E, Nozzoli C, Buda G, Staderini M, Boncompagni R, Martini F, Petrini M, Bosi A, and Saccardi R
- Subjects
- Aged, Autografts, Cyclophosphamide administration & dosage, Disease-Free Survival, Female, Granulocyte Colony-Stimulating Factor administration & dosage, Humans, Induction Chemotherapy, Male, Multiple Myeloma mortality, Retrospective Studies, Survival Rate, Bortezomib administration & dosage, Multiple Myeloma therapy, Peripheral Blood Stem Cell Transplantation
- Abstract
Objectives: ASCT is currently the "gold standard" first-line treatment for multiple myeloma patients younger than 65 years old, and limited data on efficacy and safety in older patients are available., Methods: We retrospectively analyzed a cohort of 83 newly diagnosed multiple myeloma patients aged 65 or older. All patients were evaluated for fitness at diagnosis and after bortezomib-based induction treatment., Results and Conclusions: All patients collected an adequate PBSC graft, mainly after G-CSF plus cyclophosphamide; a median of 6.47 × 10
6 /kg CD34 + cells was collected. The conditioning regimen consisted of melphalan 100, 140 and 200 mg/m2 in 40, 15 and 28 patients, respectively. Median time to neutrophils' and platelets' recovery was 11 and 12 days, respectively. Adverse events of any grade were referred by 40% of patients. The overall response rate was 93%, CR/sCR were 39%. Median PFS was 35 months; median OS was not reached. In our study cohort, the achievement of at least VGPR after induction therapy and the obtainment of CR/sCR after ASCT are the only parameters that were associated with an improved PFS. ASCT is an effective and safe first-line treatment approach, a careful patients selection reduce the toxicity of the procedure., (© 2019 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.)- Published
- 2020
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4. Daratumumab plus bortezomib and dexamethasone versus bortezomib and dexamethasone in relapsed or refractory multiple myeloma: updated analysis of CASTOR.
- Author
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Spencer A, Lentzsch S, Weisel K, Avet-Loiseau H, Mark TM, Spicka I, Masszi T, Lauri B, Levin MD, Bosi A, Hungria V, Cavo M, Lee JJ, Nooka AK, Quach H, Lee C, Barreto W, Corradini P, Min CK, Scott EC, Chanan-Khan AA, Horvath N, Capra M, Beksac M, Ovilla R, Jo JC, Shin HJ, Sonneveld P, Soong D, Casneuf T, Chiu C, Amin H, Qi M, Thiyagarajah P, Sasser AK, Schecter JM, and Mateos MV
- Subjects
- Adult, Aged, Aged, 80 and over, Antibodies, Monoclonal administration & dosage, Bortezomib administration & dosage, Dexamethasone administration & dosage, Drug Resistance, Neoplasm, Follow-Up Studies, Humans, Kaplan-Meier Estimate, Male, Middle Aged, Multiple Myeloma pathology, Neoplasm Recurrence, Local, Outcome Assessment, Health Care methods, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Multiple Myeloma drug therapy, Neoplasm, Residual diagnosis, Outcome Assessment, Health Care statistics & numerical data
- Abstract
Daratumumab, a CD38 human monoclonal antibody, demonstrated significant clinical activity in combination with bortezomib and dexamethasone versus bortezomib and dexamethasone alone in the primary analysis of CASTOR, a phase 3 study in relapsed and/or refractory multiple myeloma. A post hoc analysis based on treatment history and longer follow up is presented. After 19.4 (range: 0-27.7) months of median follow up, daratumumab plus bortezomib and dexamethasone prolonged progression-free survival (median: 16.7 versus 7.1 months; hazard ratio, 0.31; 95% confidence interval, 0.24-0.39; P <0.0001) and improved the overall response rate (83.8% versus 63.2%; P <0.0001) compared with bortezomib and dexamethasone alone. The progression-free survival benefit of daratumumab plus bortezomib and dexamethasone was most apparent in patients with 1 prior line of therapy (median: not reached versus 7.9 months; hazard ratio, 0.19; 95% con fidence interval, 0.12-0.29; P <0.0001). Daratumumab plus bortezomib and dexamethasone was also superior to bortezomib and dexamethasone alone in subgroups based on prior treatment exposure (bortezomib, thalidomide, or lenalidomide), lenalidomide-refractory status, time since last therapy (≤12, >12, ≤6, or >6 months), or cytogenetic risk. Minimal residual disease-negative rates were >2.5-fold higher with daratumumab across subgroups. The safety profile of daratumumab plus bortezomib and dexamethasone remained consistent with longer follow up. Daratumumab plus bortezomib and dexamethasone demonstrated significant clinical activity across clinically relevant subgroups and provided the greatest benefit to patients treated at first relapse. Trial registration: clinicaltrials.gov identifier: 02136134 ., (Copyright© 2018 Ferrata Storti Foundation.)
- Published
- 2018
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5. A comparative analysis of biosimilar vs. originator filgrastim in combination with plerixafor for stem cell mobilization in lymphoma and multiple myeloma: a propensity-score weighted multicenter approach.
- Author
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Lanza F, Saraceni F, Pezzi A, Martino M, Bosi A, Cascavilla N, Musto P, Zuffa E, Tani M, Cellini C, Laszlo D, and Bonifazi F
- Subjects
- Benzylamines, Biosimilar Pharmaceuticals administration & dosage, Blood Cell Count, Cyclams, Filgrastim administration & dosage, Heterocyclic Compounds administration & dosage, Humans, Lymphoma, Non-Hodgkin blood, Multiple Myeloma blood, Propensity Score, Retrospective Studies, Biosimilar Pharmaceuticals pharmacology, Filgrastim pharmacology, Hematopoietic Stem Cell Mobilization, Heterocyclic Compounds pharmacology, Lymphoma, Non-Hodgkin therapy, Multiple Myeloma therapy
- Published
- 2017
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6. Randomized phase 2 study: elotuzumab plus bortezomib/dexamethasone vs bortezomib/dexamethasone for relapsed/refractory MM.
- Author
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Jakubowiak A, Offidani M, Pégourie B, De La Rubia J, Garderet L, Laribi K, Bosi A, Marasca R, Laubach J, Mohrbacher A, Carella AM, Singhal AK, Tsao LC, Lynch M, Bleickardt E, Jou YM, Robbins M, and Palumbo A
- Subjects
- Adult, Aged, Aged, 80 and over, Antibodies, Monoclonal, Humanized adverse effects, Bortezomib adverse effects, Dexamethasone adverse effects, Female, Humans, Male, Middle Aged, Treatment Outcome, Antibodies, Monoclonal, Humanized administration & dosage, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Bortezomib administration & dosage, Dexamethasone administration & dosage, Drug Resistance, Neoplasm drug effects, Multiple Myeloma drug therapy, Neoplasm Recurrence, Local drug therapy
- Abstract
In this proof-of-concept, open-label, phase 2 study, patients with relapsed/refractory multiple myeloma (RRMM) received elotuzumab with bortezomib and dexamethasone (EBd) or bortezomib and dexamethasone (Bd) until disease progression/unacceptable toxicity. Primary endpoint was progression-free survival (PFS); secondary/exploratory endpoints included overall response rate (ORR) and overall survival (OS). Two-sided 0.30 significance level was specified (80% power, 103 events) to detect hazard ratio (HR) of 0.69. Efficacy and safety analyses were performed on all randomized patients and all treated patients, respectively. Of 152 randomized patients (77 EBd, 75 Bd), 150 were treated (75 EBd, 75 Bd). PFS was greater with EBd vs Bd (HR, 0.72; 70% confidence interval [CI], 0.59-0.88; stratified log-rank P = .09); median PFS was longer with EBd (9.7 months) vs Bd (6.9 months). In an updated analysis, EBd-treated patients homozygous for the high-affinity FcγRIIIa allele had median PFS of 22.3 months vs 9.8 months in EBd-treated patients homozygous for the low-affinity allele. ORR was 66% (EBd) vs 63% (Bd). Very good partial response or better occurred in 36% of patients (EBd) vs 27% (Bd). Early OS results, based on 40 deaths, revealed an HR of 0.61 (70% CI, 0.43-0.85). To date, 60 deaths have occurred (28 EBd, 32 Bd). No additional clinically significant adverse events occurred with EBd vs Bd. Grade 1/2 infusion reaction rate was low (5% EBd) and mitigated with premedication. In patients with RRMM, elotuzumab, an immunostimulatory antibody, appears to provide clinical benefit without added clinically significant toxicity when combined with Bd vs Bd alone. Registered to ClinicalTrials.gov as NCT01478048., (© 2016 by The American Society of Hematology.)
- Published
- 2016
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7. New patterns of relapse in multiple myeloma: a case of "light chain escape" in which FLC predicted relapse earlier than urine and serum immunofixation.
- Author
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Caldini A, Nozzoli C, Terreni A, Staderini M, Berardi M, Biagioli T, Brogi M, and Bosi A
- Subjects
- Bence Jones Protein urine, Bendamustine Hydrochloride therapeutic use, Blood Protein Electrophoresis, Bortezomib therapeutic use, Dexamethasone therapeutic use, Humans, Immunoelectrophoresis, Immunoglobulin G blood, Immunoglobulin G urine, Lenalidomide, Male, Middle Aged, Multiple Myeloma immunology, Multiple Myeloma therapy, Recurrence, Stem Cell Transplantation, Thalidomide analogs & derivatives, Thalidomide therapeutic use, Immunoglobulin kappa-Chains blood, Immunoglobulin kappa-Chains urine, Multiple Myeloma diagnosis
- Abstract
Multiple myeloma (MM) is characterized, in about 80% of cases, by the production of monoclonal intact immunoglobulin and more than 95% of them have elevated concentrations of involved (i.e. of the same class of intact immunoglobulin) free light chain (FLC). The introduction of novel therapeutic strategies has changed the natural history of the disease, leading to new manifestations of relapse. Light chain escape (LCE) is a pattern of relapse in which the FLC increase is not accompanied by a concomitant raise of the original monoclonal component (MC). Here we present a case of a 55-year-old man with an IgG kappa MM stage III diagnosed in September 2007. At presentation an IgG kappa MC and urine Bence Jones protein (BJP) kappa were present. Bone marrow biopsy (BMB) showed the presence of 80% monotypic kappa plasma cells (PCs). The patient received bortezomib, thalidomide, dexamethasone before undergoing a double autologous stem cell transplantation (ASCT) in October 2008 and April 2009. In May 2011 he relapsed showing the same pattern of presentation and treatment with lenalidomide and dexamethasone was started. ln May 2013 serum and urine immunofixation and FLC became negative. In September 2014, an increase of kappa FLC was observed, while serum and urine immunofixations remained negative until January 2015, when urine immunofixation became positive. Eventually, in February 2015, serum immunofixation revealed the presence of a free kappa MC. After a new BMB showing 80% of monotypic kappa PCs, a LCE relapse was diagnosed and the patient started the treatment with bendamustine, bortezomib and dexamethasone. In the present case, the increase of kappa FLC has indicated relapse 4 and 5 months earlier than urine and serum IFE, respectively. Our observation confirms that it is advisable to routinely perform FLC or BJP during follow up of MM patients undergoing ASCT and/or treatment with biological drugs to ensure that LCE is not missed.
- Published
- 2016
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8. Impact of disease status on outcome in relapsed and refractory multiple myeloma treated with lenalidomide.
- Author
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Nozzoli C, Staderini M, Veltroni A, Longo G, Bacchiarri F, Donnini I, Guarrera A, and Bosi A
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- Adult, Aged, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocols adverse effects, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Disease Progression, Female, Follow-Up Studies, Humans, Immunologic Factors administration & dosage, Kaplan-Meier Estimate, Lenalidomide, Male, Middle Aged, Multiple Myeloma mortality, Recurrence, Thalidomide administration & dosage, Thalidomide therapeutic use, Treatment Outcome, Antineoplastic Agents therapeutic use, Immunologic Factors therapeutic use, Multiple Myeloma diagnosis, Multiple Myeloma drug therapy, Thalidomide analogs & derivatives
- Abstract
The introduction of immunomodulatory drugs such as lenalidomide combined with dexamethasone (Len/Dex) has improved the outcome of patients with relapsed/refractory multiple myeloma (RRMM). Few data are currently available which investigate whether paraprotein relapse represents an indication for starting a new treatment. The aim of our retrospective, single-center study was to analyze the impact of disease status (relapsed/refractory) and type of relapse (clinical/paraprotein) on response rate and time-to-next-treatment (TNT). We included 74 patients (median age 70 years) with RRMM treated with Len/Dex until progression or unacceptable toxicity from 2008 to 2012. Age and disease status were not factors affecting overall response rate (ORR) and median TNT, but TNT was significantly longer in patients with asymptomatic compared to clinical relapse (34 vs. 19 months, p<0.008). In conclusion, Len/Dex represents an effective treatment with satisfactory ORR and outcomes in RRMM, especially for patients starting therapy in asymptomatic relapse.
- Published
- 2015
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9. Factors affecting successful mobilization with plerixafor: an Italian prospective survey in 215 patients with multiple myeloma and lymphoma.
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Lanza F, Lemoli RM, Olivieri A, Laszlo D, Martino M, Specchia G, Pavone V, Imola M, Pasini A, Milone G, Scortechini I, Todisco E, Guggiari E, Cascavilla N, Martinelli G, Rambaldi A, and Bosi A
- Subjects
- Adolescent, Adult, Aged, Benzylamines, Blood Component Removal methods, Chemoradiotherapy, Cyclams, Data Collection, Female, Humans, Italy, Leukapheresis methods, Male, Middle Aged, Platelet Count, Predictive Value of Tests, Prospective Studies, Young Adult, Hematopoietic Stem Cell Mobilization methods, Heterocyclic Compounds therapeutic use, Lymphoma therapy, Multiple Myeloma therapy, Receptors, CXCR4 antagonists & inhibitors
- Abstract
Background: Although the efficacy of plerixafor in peripheral blood stem cell (PBSC) mobilization has been explored in several studies, factors associated with successful plerixafor mobilization after administration of granulocyte-colony-stimulating factor (G-CSF), with or without chemotherapy, have not been investigated. We analyzed data on PBSC mobilization from a large Italian database of lymphoma and myeloma plerixafor-treated patients., Study Design and Methods: Two endpoints were established to define successful mobilization: patients with at least 2 × 10(6) CD34+ cells/kg collected by three leukapheresis procedures and patients achieving a peak count of at least 20 × 10(6) CD34+ cells/L during mobilization., Results: Plerixafor achieved successful mobilization in both predicted (n = 64) and proven poor mobilizers (PMs; n = 143), classified according to the Gruppo Italiano Trapianto di Midollo Osseo (GITMO) criteria. Successful mobilization was independent of type of mobilization (steady state or chemotherapy); age; sex; disease; number or type of chemotherapy regimens preceding plerixafor; radiation therapy; prior treatment with melphalan, carmustine, lenalidomide, and radioimmune conjugates; and laboratory variables. Multivariate analysis identified previous fludarabine treatment and premobilization platelet count as predictors of successful mobilization., Conclusion: This large, prospective, nationwide study confirmed plerixafor efficacy for mobilizing PBSCs when added to G-CSF with or without chemotherapy. Plerixafor can overcome negative effects of most predictors of poor mobilization to achieve satisfactory harvest both in predicted and proven PM., (© 2013 American Association of Blood Banks.)
- Published
- 2014
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10. The costs of mobilisation and collection of peripheral blood stem cells in multiple myeloma and lymphoma in an European country: results from The Gruppo Italiano Trapianto Midollo Osseo (GITMO) and Società Italiana di Emaferesi e Manipolazione Cellulare (SIdEM) survey.
- Author
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Pierelli L, Berto P, Accorsi P, Milone G, Lopatriello S, Aiello A, Iacopino P, Olivieri A, Rambaldi A, and Bosi A
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- Data Collection, European Union, Female, Health Care Costs, Hematopoietic Stem Cell Mobilization methods, Hematopoietic Stem Cell Transplantation methods, Humans, Italy, Lymphoma economics, Male, Middle Aged, Multiple Myeloma economics, Peripheral Blood Stem Cell Transplantation methods, Surveys and Questionnaires, Transplantation Conditioning, Transplantation, Autologous, Hematopoietic Stem Cell Mobilization economics, Hematopoietic Stem Cell Transplantation economics, Lymphoma surgery, Multiple Myeloma surgery, Peripheral Blood Stem Cell Transplantation economics
- Abstract
Scarce information is available about the cost of mobilisation/collection of peripheral blood stem cells for patients undergoing autologous transplant for relapsed Lymphoma or Multiple Myeloma. This paper reports the consumption of resources and costs collected through a survey among Italian Centres who adhere to the GITMO and SIdEM scientific societies. General transplant information was extracted from the European Promise database. Resources used alongside the phases of mobilisation/collection were retrieved. Resources for each of the process phases were quantified and averaged across centres and a unit cost value was attributed, based on administrative data from 3 centres, tariffs and market values. 25/89 Centres (34% of 2009 Promise transplants) provided data according to their standard practice. The mean cost/patient of the process of cell mobilisation/collection was € 6830 ± 1802 for Multiple Myeloma and € 7304 ± 1542 for Lymphoma. The organisational path for PBSC mobilisation/collection appears complex and cumbersome, spread amongst different treatment settings, with many different healthcare professionals being involved and considerable amounts of time and resources being currently dedicated to the management of patients requiring autologous transplantation., (Copyright © 2013 Elsevier Ltd. All rights reserved.)
- Published
- 2013
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11. Autologous/reduced-intensity allogeneic stem cell transplantation vs autologous transplantation in multiple myeloma: long-term results of the EBMT-NMAM2000 study.
- Author
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Gahrton G, Iacobelli S, Björkstrand B, Hegenbart U, Gruber A, Greinix H, Volin L, Narni F, Carella AM, Beksac M, Bosi A, Milone G, Corradini P, Schönland S, Friberg K, van Biezen A, Goldschmidt H, de Witte T, Morris C, Niederwieser D, Garderet L, and Kröger N
- Subjects
- Aged, Disease-Free Survival, Female, Follow-Up Studies, Hematopoietic Stem Cell Transplantation mortality, Humans, Male, Middle Aged, Multiple Myeloma mortality, Time, Transplantation, Autologous methods, Transplantation, Homologous methods, Treatment Outcome, Hematopoietic Stem Cell Transplantation methods, Multiple Myeloma surgery, Transplantation Conditioning methods
- Abstract
Long-term follow-up of prospective studies comparing allogeneic transplantation to autologous transplantation in multiple myeloma is few and controversial. This is an update at a median follow-up of 96 months of the European Group for Blood and Marrow Transplantation Non-Myeloablative Allogeneic stem cell transplantation in Multiple Myeloma (NMAM)2000 study that prospectively compares tandem autologous/reduced intensity conditioning allogeneic transplantation (auto/RICallo) to autologous transplantation alone (auto). There are 357 myeloma patients up to age 69 years enrolled. Patients with an HLA-identical sibling were allocated to auto/RICallo (n = 108) and those without to auto alone (n = 249). At 96 months progression-free survival (PFS) and overall survival (OS) were 22% and 49% vs 12% (P = .027) and 36% (P = .030) with auto/RICallo and auto respectively. The corresponding relapse/progression rate (RL) was 60% vs 82% (P = .0002). Non-relapse mortality at 36 months was 13% vs 3% (P = .0004). In patients with the del(13) abnormality corresponding PFS and OS were 21% and 47% vs 5% (P = .026), and 31% (P = .154). Long-term outcome in patients with multiple myeloma was better with auto/RICallo as compared with auto only and the auto/RICallo approach seemed to overcome the poor prognostic impact of del(13) observed after autologous transplantation. Follow up longer than 5 years is necessary for correct interpretation of the value of auto/RICallo in multiple myeloma.
- Published
- 2013
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12. Allogeneic hematopoietic cell transplantation from unrelated donors in multiple myeloma: study from the Italian Bone Marrow Donor Registry.
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Passera R, Pollichieni S, Brunello L, Patriarca F, Bonifazi F, Montefusco V, Falda M, Montanari M, Guidi S, Giaccone L, Mordini N, Carella AM, Bavaro P, Milone G, Benedetti F, Ciceri F, Scimè R, Benedetti E, Castagna L, Festuccia M, Rambaldi A, Bacigalupo A, Corradini P, Bosi A, Boccadoro M, Bandini G, Fanin R, and Bruno B
- Subjects
- Acute Disease, Adult, Aged, Chronic Disease, Female, Graft vs Host Disease immunology, Graft vs Host Disease mortality, Graft vs Host Disease pathology, Humans, Italy, Male, Middle Aged, Multiple Myeloma immunology, Multiple Myeloma mortality, Multiple Myeloma pathology, Retrospective Studies, Survival Analysis, Transplantation, Homologous, Treatment Outcome, Graft vs Host Disease therapy, Hematopoietic Stem Cell Transplantation, Multiple Myeloma therapy, Myeloablative Agonists therapeutic use, Registries, Transplantation Conditioning methods, Unrelated Donors
- Abstract
To evaluate trends in allografting from unrelated donors, we conducted a study on 196 consecutive myeloma patients transplanted between 2000 and 2009 in Italy. Twenty-eight percent, 37%, and 35%, respectively, received myeloablative, reduced-intensity, and nonmyeloablative conditioning. In these 3 cohorts, 1-year and 5-year transplantation-related mortalities were 28.8% and 37.0%, 20.3% and 31.3%, and 25.0% and 30.3%, respectively (P = .745). Median overall survival (OS) and event-free survival from transplantation for the 3 cohorts were 29 and 10 months, 11 and 6 months, and 32 and 13 months, respectively (P = .039 and P = .049). Overall cumulative incidences of acute and chronic graft-versus-host-disease (GVHD) were 46.1% and 51.1%. By Cox multivariate analyses, chronic GVHD was significantly associated with longer OS (hazard ratio [HR], .51; P = .009), whereas the use of peripheral blood stem cells was borderline significant (HR, .55; P = .051). Better response posttransplantation was associated with longer event-free survival (HR, 2.13 to 4.25; P < .001). Acute GVHD was associated with poorer OS (HR, 2.53; P = .001). This analysis showed a strong association of acute and chronic GVHD and depth of response posttransplantation with clinical outcomes. Long-term disease control remains challenging regardless of the conditioning. In the light of these results, prospective trials may be designed to better define the role of allografting from unrelated donors in myeloma., (Copyright © 2013 American Society for Blood and Marrow Transplantation. Published by Elsevier Inc. All rights reserved.)
- Published
- 2013
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13. Stiff skin syndrome and myeloma successfully treated with autologous haematopoietic stem cell transplantation (HSCT).
- Author
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Bandinelli F, Saccardi R, Salvadorini G, Bosi A, Gozzini A, and Matucci Cerinic M
- Subjects
- Contracture complications, Humans, Male, Middle Aged, Multiple Myeloma complications, Skin Diseases, Genetic complications, Transplantation, Autologous, Treatment Outcome, Contracture therapy, Hematopoietic Stem Cell Transplantation methods, Multiple Myeloma therapy, Skin Diseases, Genetic therapy
- Abstract
Stiff skin syndrome (SSS) is a rare scleroderma-like syndrome characterised by stone hard skin, joint limitation and progressive restriction of chest that may lead to death. We describe the efficacy of haematopoietic autologous stem cell transplantation (HSCT) in a case of SSS secondary to a smouldering myeloma (SM), with severe joint disability, lung interstitial disease and oesophageal dysfunction. The patient was evaluated at 1, 12 and 18 months after HSCT, clinically (joint motility, HAQ and NYHA for dyspnoea) and instrumentally (DLCO, chest HRCT, oesophagus x-ray). After 18 months since HSCT, we observed a high improvement, contemporaneously to SM remission, of HAQ, joint motility, lung (at DLCO and HRCT) and oesophageal abnormalities.
- Published
- 2013
14. Allogeneic stem cell transplantation in multiple myeloma relapsed after autograft: a multicenter retrospective study based on donor availability.
- Author
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Patriarca F, Einsele H, Spina F, Bruno B, Isola M, Nozzoli C, Nozza A, Sperotto A, Morabito F, Stuhler G, Festuccia M, Bosi A, Fanin R, and Corradini P
- Subjects
- Adult, Aged, Antineoplastic Agents administration & dosage, Boronic Acids administration & dosage, Boronic Acids therapeutic use, Bortezomib, Disease-Free Survival, Graft vs Host Disease immunology, Histocompatibility Testing, Humans, Middle Aged, Multiple Myeloma immunology, Multiple Myeloma mortality, Myeloablative Agonists administration & dosage, Myeloablative Agonists therapeutic use, Pyrazines administration & dosage, Pyrazines therapeutic use, Recurrence, Retrospective Studies, Salvage Therapy, Thalidomide administration & dosage, Thalidomide therapeutic use, Tissue Donors, Transplantation, Autologous, Antineoplastic Agents therapeutic use, Graft vs Host Disease prevention & control, Hematopoietic Stem Cell Transplantation, Multiple Myeloma therapy, Transplantation Conditioning
- Abstract
Allogeneic stem cell transplantation (allo-SCT) using reduced-intensity conditioning (RIC) is a feasible procedure in selected patients with relapsed multiple myeloma (MM), but its efficacy remains a matter of debate. The mortality and morbidity related to the procedure and the rather high relapse risk make the use of allo-SCT controversial. In addition, the availability of novel antimyeloma treatments, such as bortezomib and immunomodulatory agents, have made allo-SCT less appealing to clinicians. We investigated the role of RIC allo-SCT in patients with MM who relapsed after autologous stem cell transplantation and were then treated with a salvage therapy based on novel agents. This study was structured similarly to an intention-to-treat analysis and included only those patients who underwent HLA typing immediately after the relapse. Patients with a donor (donor group) and those without a suitable donor (no-donor group) were compared. A total of 169 consecutive patients were evaluated retrospectively in a multicenter study. Of these, 75 patients found a donor and 68 (91%) underwent RIC allo-SCT, including 24 from an HLA-identical sibling (35%) and 44 from an unrelated donor (65%). Seven patients with a donor did not undergo allo-SCT for progressive disease or concomitant severe comorbidities. The 2-year cumulative incidence of nonrelapse mortality was 22% in the donor group and 1% in the no-donor group (P < .0001). The 2-year progression-free survival (PFS) was 42% in the donor group and 18% in the no-donor group (P < .0001). The 2-year overall survival (OS) was 54% in the donor group and 53% in the no-donor group (P = .329). In multivariate analysis, lack of a donor was a significant unfavorable factor for PFS, but not for OS. Lack of chemosensitivity after salvage treatment and high-risk karyotype at diagnosis significantly shortened OS. In patients who underwent allo-SCT, the development of chronic graft-versus-host disease had a significant protective effect on OS. This study provides evidence for a significant PFS benefit of salvage treatment with novel drugs followed by RIC allo-SCT in patients with relapsed MM who have a suitable donor., (Copyright © 2012 American Society for Blood and Marrow Transplantation. Published by Elsevier Inc. All rights reserved.)
- Published
- 2012
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15. Tandem autologous/reduced-intensity conditioning allogeneic stem-cell transplantation versus autologous transplantation in myeloma: long-term follow-up.
- Author
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Björkstrand B, Iacobelli S, Hegenbart U, Gruber A, Greinix H, Volin L, Narni F, Musto P, Beksac M, Bosi A, Milone G, Corradini P, Goldschmidt H, de Witte T, Morris C, Niederwieser D, and Gahrton G
- Subjects
- Adult, Aged, Disease-Free Survival, Female, Follow-Up Studies, Graft vs Host Disease etiology, Hematopoietic Stem Cell Transplantation adverse effects, Hematopoietic Stem Cell Transplantation mortality, Humans, Incidence, Kaplan-Meier Estimate, Male, Middle Aged, Multiple Myeloma pathology, Multiple Myeloma radiotherapy, Myeloablative Agonists administration & dosage, Neoplasm Staging, Prospective Studies, Recurrence, Time Factors, Transplantation, Autologous, Transplantation, Homologous, Treatment Outcome, Vidarabine administration & dosage, Vidarabine analogs & derivatives, Hematopoietic Stem Cell Transplantation methods, Multiple Myeloma surgery, Transplantation Conditioning methods
- Abstract
Purpose: Results of allogeneic stem-cell transplantation (allo) in myeloma are controversial. In this trial autologous stem-cell transplantation (auto) followed by reduced-intensity conditioning matched sibling donor allo (auto-allo) was compared with auto only in previously untreated multiple myeloma., Patients and Methods: In all, 357 patients with myeloma up to age 69 years were enrolled from 2001 to 2005. Patients with an HLA-identical sibling donor were allocated to the auto-allo arm (n = 108) and patients without a matched sibling donor were allocated to the auto arm (n = 249). Single (n = 145) or tandem (n = 104) auto was optional. Conditioning for the auto arm was melphalan 200 mg/m(2); conditioning for the allo arm was total-body irradiation 2 Gy plus fludarabine 30 mg/m(2)/d for 3 days. Median follow-up time was 61 months. Primary end point was progression-free survival., Results: Progression-free survival at 60 months was significantly better with auto-allo than with auto [corrected] alone (35% v 18%; P = .001), as was the risk of death and of relapse in the long term (P = .047 and P = .003, respectively). Overall survival at 60 months was 65% versus 58%, and relapse incidence was 49% versus 78%. Complete remission rates were 51% and 41%, respectively (P = .020). Nonrelapse mortality at 24 months was 12% after auto-allo compared with 3% in the auto group (P < .001). The incidence of grade 2 to 4 acute graft-versus-host disease (GvHD) was 20%, and the incidence of limited and extensive chronic GvHD was 31% and 23%., Conclusion: In patients with previously untreated multiple myeloma, long-term outcome with respect to progression-free survival, overall survival, and relapse rate is superior after auto-allo compared with auto only. Nonrelapse mortality is at a reasonable level in both groups.
- Published
- 2011
- Full Text
- View/download PDF
16. The role of bortezomib, thalidomide and lenalidomide in the management of multiple myeloma: an overview of clinical and economic information.
- Author
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Messori A, Maratea D, Nozzoli C, and Bosi A
- Subjects
- Bortezomib, Clinical Trials as Topic, Cost-Benefit Analysis, Humans, Lenalidomide, Boronic Acids economics, Boronic Acids therapeutic use, Multiple Myeloma drug therapy, Pyrazines economics, Pyrazines therapeutic use, Thalidomide analogs & derivatives, Thalidomide economics, Thalidomide therapeutic use
- Abstract
Bortezomib, thalidomide and lenalidomide can be aimed at treating patients with newly diagnosed multiple myeloma (both eligible and ineligible for transplantation) as well as those with relapsed or refractory disease. This review analysed the available clinical and economic data on these three drugs. Irrespective of which of the three agents is considered, the magnitude of the benefit in newly diagnosed cases (transplanted or non-transplanted) tends to be between 10 and 20 months per patient in terms of progression-free survival or survival; the survival benefit is smaller in relapsed or refractory disease. In addition, a single-institution observational analysis evaluated the outcomes in nearly 3000 consecutive patients examined between 1971 and 2006. The survival in patients diagnosed between 2001 and 2006 was longer than that observed in patients diagnosed between 1994 and 2000. This finding supports the conclusion that novel agents provide a survival improvement compared with traditional therapy. Formal cost-effectiveness studies on these three agents are still lacking. A MEDLINE search retrieved only four short papers or letters and no full-length analysis. Hence, the cost effectiveness of these agents needs further investigation, with separate assessments of the different therapeutic settings. In a simplified analysis, we tried to contrast the average cost of treatment for each of the novel agents versus their respective benefit, expressed in quality-adjusted survival. Despite its preliminary nature, our assessment indicates that the cost effectiveness of these three agents is likely to be within commonly accepted pharmacoeconomic thresholds.
- Published
- 2011
- Full Text
- View/download PDF
17. The addition of liposomal doxorubicin to bortezomib, thalidomide and dexamethasone significantly improves clinical outcome of advanced multiple myeloma.
- Author
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Ciolli S, Leoni F, Casini C, Breschi C, Santini V, and Bosi A
- Subjects
- Adult, Aged, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocols adverse effects, Boronic Acids administration & dosage, Boronic Acids adverse effects, Bortezomib, Dexamethasone administration & dosage, Dexamethasone adverse effects, Disease Progression, Doxorubicin administration & dosage, Doxorubicin adverse effects, Female, Humans, Liposomes, Male, Middle Aged, Pyrazines administration & dosage, Pyrazines adverse effects, Survival Analysis, Thalidomide administration & dosage, Thalidomide adverse effects, Treatment Outcome, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Multiple Myeloma drug therapy
- Abstract
Relapsed/refractory myeloma has a poor outcome because of multi-drug resistance, patient low-performance status and toxicity of conventional chemotherapy. To improve results, standard chemotherapeutics and drugs targeting the microenvironment are applied at the same time. Bortezomib, by inhibiting proteasome function, may enhance chemosensitivity to other drugs and overcome drug-resistance. Notably, doxorubicin and bortezomib may reciprocally increase their efficacy. Thus, to improve outcome whilst minimizing therapy-related toxicity, liposomal doxorubicin was added to a bortezomib-based combination. From January 2004, relapsed/refractory myeloma patients referred to our Institution received bortezomib 1.0 mg/m(2) i.v. twice weekly for 2 weeks in a 28-d cycle for up to six cycles, oral dexamethasone 24 mg with the standard scheduling and thalidomide 100 mg continuously (VTD). From January 2005, liposomal doxorubicin, 50 mg/m(2) (30 mg/m(2) for patients older than 75 years), was added on day 4 of each cycle [VTD plus Myocet (MyVTD)]. In total, 70 patients were treated: 28 received VTD and 42 MyVTD. Baseline demographic and clinical characteristics were similar between the two groups. Toxicity was manageable although more pronounced with MyVTD. The overall response rate (81% vs. 50%, P = 0.009), time to progression (19 vs. 11 months, P = 0.01) and progression-free survival (15 vs. 8 months, P = 0.001) were significantly higher with MyVTD regimen, suggesting an improved quality of response.
- Published
- 2008
- Full Text
- View/download PDF
18. Unrelated donor haematopoietic cell transplantation after non-myeloablative conditioning for patients with high-risk multiple myeloma.
- Author
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Bruno B, Sorasio R, Patriarca F, Montefusco V, Guidi S, Busca A, Scimé R, Console G, Milone G, Marotta G, Dominietto A, Giaccone L, Rotta M, Falda M, Bacigalupo A, Bosi A, Corradini P, Fanin R, Pollichieni S, and Boccadoro M
- Subjects
- Adult, Disease Progression, Disease-Free Survival, Female, Follow-Up Studies, Graft vs Host Disease therapy, Hematopoietic Stem Cell Transplantation methods, Humans, Male, Middle Aged, Neoplasm Staging, Risk Factors, Salvage Therapy, Survival Rate, Transplantation Conditioning methods, Transplantation, Homologous, Treatment Outcome, Hematopoietic Stem Cell Transplantation adverse effects, Multiple Myeloma therapy, Transplantation Conditioning adverse effects
- Abstract
Background: Allografting induces long-term molecular remissions and possibly cure in myeloma patients. The development of non-myeloablative conditionings has reduced the transplant-related mortality (TRM) associated with myeloablation and extended the eligible age for transplantation. Moreover, high response rates are reported especially when allografting is preceded by cytoreductive high-dose chemotherapy. We investigated the feasibility of unrelated donor non-myeloablative transplantation as either part of the initial treatment plan or as salvage treatment in heavily pretreated patients., Methods: Twenty-two patients underwent non-myeloablative allografting, 10 as part of their initial treatment and 12 at relapse. Donors were matched for HLA-A, B, C, DRB1 and DQB1 by high-resolution typing. Only one single class I allele disparity was allowed. Conditioning consisted of fludarabine 90 mg/m(2) and 2 Gy total body irradiation. Graft-vs.-host disease (GVHD) prophylaxis included cyclosporin and mycophenolate mofetil., Results: All patients except two (91%) readily engrafted. After a median follow-up of 20 (10-30) months, incidences of grade II-IV acute and extensive chronic GVHD were 50% and 61%. Overall response (OR) was 55%, with four (20%) complete and seven (35%) partial remissions. However, in patients allografted up-front OR was 89% whereas in the heavily pretreated group OR was 27% (P = 0.01). Two-year overall and event-free survivals were both 79% in the group transplanted up-front and 27% and 25% among relapsed patients (P = 0.025 and P = 0.006, respectively). Overall, six patients died of TRM and three of disease progression., Conclusions: Unrelated donor non-myeloablative allografting is feasible in myeloma. Disease control appears more pronounced when patients are treated soon after diagnosis.
- Published
- 2007
- Full Text
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19. Percutaneous vertebroplasty and kyphoplasty in patients with multiple myeloma.
- Author
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Bartolozzi B, Nozzoli C, Pandolfo C, Antonioli E, Guizzardi G, Morichi R, and Bosi A
- Subjects
- Aged, Female, Humans, Male, Middle Aged, Spinal Fractures diagnostic imaging, Tomography, X-Ray Computed, Treatment Outcome, Multiple Myeloma surgery, Spinal Fractures surgery, Spine surgery
- Published
- 2006
- Full Text
- View/download PDF
20. Osteonecrosis of the jaw associated with zoledronate therapy in a patient with multiple myeloma.
- Author
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Vannucchi AM, Ficarra G, Antonioli E, and Bosi A
- Subjects
- Aged, Humans, Male, Zoledronic Acid, Diphosphonates adverse effects, Imidazoles adverse effects, Jaw, Multiple Myeloma drug therapy, Osteonecrosis chemically induced
- Published
- 2005
- Full Text
- View/download PDF
21. Aggressive Disease Course of Multiple Myeloma with Concomitant ALK-Negative Anaplastic Large Cell Lymphoma: A Case Report with an Unusual Presentation.
- Author
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Staderini, Michela, Mannelli, Lara, Antonioli, Elisabetta, Puccini, Benedetta, Berti, Valentina, Mungai, Francesco, Vergoni, Federica, Carrai, Valentina, Rigacci, Luigi, and Bosi, Alberto
- Subjects
CUTANEOUS T-cell lymphoma ,MULTIPLE myeloma ,HEMATOPOIETIC stem cell transplantation ,DISEASE progression ,LYMPHOMAS ,SKELETAL muscle - Abstract
ALK-negative anaplastic large cell lymphoma is a rare T-cell neoplasm with an aggressive course requiring prompt diagnostic work-up and treatment. Few cases of concomitant multiple myeloma and T-cell neoplasm are described in the literature, mainly regarding primary cutaneous anaplastic large cell lymphoma. We present the case of a 65-year-old man, simultaneously diagnosed with ALK-negative anaplastic large cell lymphoma with extranodal localization in the gastrocnemius muscle (stage 1AE) and IgG lambda multiple myeloma (ISS 2, Durie-Salmon stage 3A). Both diseases required therapeutic intervention due to the high proliferative index of lymphoma and the presence of bone lesions attributable to myeloma. The therapeutic program initially included chemotherapy (cyclophosphamide, doxorubicin, vincristine, etoposide, and prednisone; CHOEP), radiotherapy on the leg, bortezomib, and then consolidation with autologous hematopoietic stem cell transplantation. Despite being on bortezomib treatment and waiting for transplantation, the patient experienced an early myeloma progression that turned out to be refractory to second-line lenalidomide-based treatment. To our knowledge, this is the first case of concurrent diagnosis of extranodal ALK-negative anaplastic large cell lymphoma of the muscle and multiple myeloma. Simultaneous onset can be challenging for clinicians as both diseases may have an aggressive course requiring multiple treatments with increased risk of toxicity and complicated management. [ABSTRACT FROM AUTHOR]
- Published
- 2020
- Full Text
- View/download PDF
22. New patterns of relapse in multiple myeloma: a case of "light chain escape"in which FLC predicted relapse earlier than urine and serum immunofixation.
- Author
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Caldini, Anna, Nozzoli, Chiara, Terreni, Alessandro, Staderini, Michela, Berardi, Margherita, Biagioli, Tiziana, Brogi, Marco, and Bosi, Alberto
- Subjects
MULTIPLE myeloma diagnosis ,PLASMA cell diseases ,IMMUNOGLOBULINS ,BONE marrow examination ,STEM cell transplantation ,BLOOD protein electrophoresis ,THERAPEUTICS - Abstract
Multiple myeloma (MM) is characterized, in about 80% of cases, by the production of monoclonal intact immunoglobulin and more than 95% of them have elevated concentrations of involved (i.e. of the same class of intact immunoglobulin) free light chain (FLC). The introduction of novel therapeutic strategies has changed the natural history of the disease, leading to new manifestations of relapse. Light chain escape (LCE) is a pattern of relapse in which the FLC increase is not accompanied by a concomitant raise of the original monoclonal component (MC). Here we present a case of a 55-year-old man with an IgG kappa MM stage III diagnosed in September 2007. At presentation an IgG kappa MC and urine Bence Jones protein (BJP) kappa were present. Bone marrow biopsy (BMB) showed the presence of 80% monotypic kappa plasma cells (PCs). The patient received bortezomib, thalidomide, dexamethasone before undergoing a double autologous stem cell transplantation (ASCT) in October 2008 and April 2009. In May 2011 he relapsed showing the same pattern of presentation and treatment with lenalidomide and dexamethasone was started. ln May 2013 serum and urine immunofixation and FLC became negative. In September 2014, an increase of kappa FLC was observed, while serum and urine immunofixations remained negative until January 2015, when urine immunofixation became positive. Eventually, in February 2015, serum immunofixation revealed the presence of a free kappa MC. After a new BMB showing 80% of monotypic kappa PCs, a LCE relapse was diagnosed and the patient started the treatment with bendamustine, bortezomib and dexamethasone. In the present case, the increase of kappa FLC has indicated relapse 4 and 5 months earlier than urine and serum IFE, respectively. Our observation confirms that it is advisable to routinely perform FLC or BJP during follow up of MM patients undergoing ASCT and/ or treatment with biological drugs to ensure that LCE is not missed. [ABSTRACT FROM AUTHOR]
- Published
- 2016
- Full Text
- View/download PDF
23. Move on air: Webinar for education in stem cells mobilization Report I.
- Author
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Buchi, Francesca, Ravelli, Andrea, Olivieri, Attilio, Pierelli, Luca, Lemoli, Roberto, Accorsi, Patrizia, Lanza, Francesco, and Bosi, Alberto
- Subjects
STEM cells ,STEM cell transplantation ,MULTIPLE myeloma - Abstract
The article presents a report from a webinar for education in stem cells mobilization that discusses autologous stem cell transplantation (ASCT) as therapy for chemosensitive lymphoma or multiple myeloma (MM) patients and eligibility of patients to the mobilization of stem cells.
- Published
- 2015
24. Daratumumab plus bortezomib and dexamethasone versus bortezomib and dexamethasone in relapsed or refractory multiple myeloma: updated analysis of CASTOR
- Author
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Asher Chanan-Khan, Ajay K. Nooka, Wolney Barreto, Pieter Sonneveld, Suzanne Lentzsch, Meral Beksac, Katja Weisel, Paolo Corradini, Tineke Casneuf, Hervé Avet-Loiseau, Cindy Lee, A. Kate Sasser, Emma C. Scott, Vania Hungria, Roberto Ovilla, David Soong, Maria-Victoria Mateos, Christopher Chiu, Jae Cheol Jo, Piruntha Thiyagarajah, Tamás Masszi, Ivan Spicka, Andrew Spencer, Alberto Bosi, Je-Jung Lee, Birgitta Lauri, Tomer M Mark, Ho Jin Shin, Michele Cavo, Chang-Ki Min, Ming Qi, Himal Amin, Noemi Horvath, Mark-David Levin, Jordan M. Schecter, Marcelo Capra, Hang Quach, Radiotherapy, Spencer, Andrew, Lentzsch, Suzanne, Weisel, Katja, Avet-Loiseau, Hervé, Mark, Tomer M, Spicka, Ivan, Masszi, Tama, Lauri, Birgitta, Levin, Mark-David, Bosi, Alberto, Hungria, Vania, Cavo, Michele, Lee, Je-Jung, Nooka, Ajay K, Quach, Hang, Lee, Cindy, Barreto, Wolney, Corradini, Paolo, Min, Chang-Ki, Scott, Emma C, Chanan-Khan, Asher A, Horvath, Noemi, Capra, Marcelo, Beksac, Meral, Ovilla, Roberto, Jo, Jae-Cheol, Shin, Ho-Jin, Sonneveld, Pieter, Soong, David, Casneuf, Tineke, Chiu, Christopher, Amin, Himal, Qi, Ming, Thiyagarajah, Piruntha, Sasser, A Kate, Schecter, Jordan M, and Mateos, Maria-Victoria
- Subjects
Oncology ,medicine.medical_specialty ,Phases of clinical research ,Cytogenetics and Molecular Genetic ,03 medical and health sciences ,0302 clinical medicine ,Median follow-up ,Internal medicine ,hemic and lymphatic diseases ,Medicine ,Multiple myeloma ,Dexamethasone ,Minimal Residual Disease ,business.industry ,Bortezomib ,Hazard ratio ,Daratumumab ,Hematology ,prior therapy ,medicine.disease ,Minimal residual disease ,030220 oncology & carcinogenesis ,Quality of Life ,business ,Multiple Myeloma ,030215 immunology ,medicine.drug - Abstract
Daratumumab, a CD38 human monoclonal antibody, demonstrated significant clinical activity in combination with bortezomib and dexamethasone versus bortezomib and dexamethasone alone in the primary analysis of CASTOR, a phase 3 study in relapsed and/or refractory multiple myeloma. A post hoc analysis based on treatment history and longer follow-up is presented. After 19.4 (range: 0 to 27.7) months of median follow-up, daratumumab plus bortezomib and dexamethasone prolonged progression-free survival (median: 16.7 versus 7.1 months; hazard ratio, 0.31; 95% confidence interval, 0.24-0.39; P 12, ≤6, or >6 months), or cytogenetic risk. Minimal residual disease-negative rates were >2.5-fold higher with daratumumab across subgroups. The safety profile of daratumumab plus bortezomib and dexamethasone remained consistent with longer follow-up. Daratumumab plus bortezomib and dexamethasone demonstrated significant clinical activity across clinically relevant subgroups and provided the greatest benefit to patients treated at first relapse.
- Published
- 2018
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