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Hartmut Goldschmidt - One of the best experts on this subject based on the ideXlab platform.
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cytogenetics and long term survival of patients with refractory or relapsed and refractory multiple myeloma treated with pomalidomide and low dose Dexamethasone
Haematologica, 2015Co-Authors: Meletios A. Dimopoulos, Hartmut Goldschmidt, Katja Weisel, Lionel Karlin, Philippe Moreau, Albert Oriol, Kevin W Song, Michel Delforge, Anne Banos, Laurent GarderetAbstract:Patients with refractory or relapsed and refractory multiple myeloma who no longer receive benefit from novel agents have limited treatment options and short expected survival. del(17p) and t(4;14) are correlated with shortened survival. The phase 3 MM-003 trial demonstrated significant progression-free and overall survival benefits from treatment with pomalidomide plus low-dose Dexamethasone compared to high-dose Dexamethasone among patients in whom bortezomib and lenalidomide treatment had failed. At an updated median follow-up of 15.4 months, the progression-free survival was 4.0 versus 1.9 months (HR, 0.50; P<0.001), and median overall survival was 13.1 versus 8.1 months (HR, 0.72; P=0.009). Pomalidomide plus low-dose Dexamethasone, compared with high-dose Dexamethasone, improved progression-free survival in patients with del(17p) (4.6 versus 1.1 months; HR, 0.34; P <0.001), t(4;14) (2.8 versus 1.9 months; HR, 0.49; P=0.028), and in standard-risk patients (4.2 versus 2.3 months; HR, 0.55; P<0.001). Although the majority of patients treated with high-dose Dexamethasone took pomalidomide after discontinuation, the overall survival of patients treated with pomalidomide plus low-dose Dexamethasone or high-dose Dexamethasone was 12.6 versus 7.7 months (HR, 0.45; P=0.008) in patients with del(17p), 7.5 versus 4.9 months (HR, 1.12; P=0.761) in those with t(4;14), and 14.0 versus 9.0 months (HR, 0.85; P=0.380) in standard-risk subjects. The overall response rate was higher in patients treated with pomalidomide plus low-dose Dexamethasone than in those treated with high-dose Dexamethasone both among standard-risk patients (35.2% versus 9.7%) and those with del(17p) (31.8% versus 4.3%), whereas it was similar in patients with t(4;14) (15.9% versus 13.3%). The safety of pomalidomide plus low-dose Dexamethasone was consistent with initial reports. In conclusion, pomalidomide plus low-dose Dexamethasone is efficacious in patients with relapsed/refractory multiple myeloma and del(17p) and/or t(4;14). This study is registered at ClinicalTrials.gov as NCT01311687 and with EudraCT as 2010-019820-30.
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pomalidomide plus low dose Dexamethasone versus high dose Dexamethasone alone for patients with relapsed and refractory multiple myeloma mm 003 a randomised open label phase 3 trial
Lancet Oncology, 2013Co-Authors: Hartmut Goldschmidt, Katja Weisel, Lionel Karlin, Philippe Moreau, Michel Delforge, Jesus San F Miguel, Martha Q Lacy, Kijoung Song, Anne BanosAbstract:Summary Background Few eff ective treatments exist for patients with refractory or relapsed and refractory multiple myeloma not responding to treatment with bortezomib and lenalidomide. Pomalidomide alone has shown limited effi cacy in patients with relapsed multiple myeloma, but synergistic eff ects have been noted when combined with Dexamethasone. We compared the effi cacy and safety of pomalidomide plus low-dose Dexamethasone with high-dose Dexamethasone alone in these patients. Methods This multicentre, open-label, randomised phase 3 trial was undertaken in Australia, Canada, Europe, Russia, and the USA. Patients were eligible if they had been diagnosed with refractory or relapsed and refractory multiple myeloma, and had failed at least two previous treatments of bortezomib and lenalidomide. They were assigned in a 2:1 ratio with a validated interactive voice and internet response system to either 28 day cycles of pomalidomide (4 mg/day on days 1–21, orally) plus low-dose Dexamethasone (40 mg/day on days 1, 8, 15, and 22, orally) or high-dose Dexamethasone (40 mg/day on days 1–4, 9–12, and 17–20, orally) until disease progression or unacceptable toxicity . Stratifi cation factors were age (≤75 years vs >75 years), disease population (refractory vs relapsed and refractory vs bortezomib intolerant), and number of previous treatments (two vs more than two). The primary endpoint was progression-free survival (PFS). Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT01311687, and with EudraCT, number 2010-019820-30. Findings The accrual for the study has been completed and the analyses are presented. 302 patients were randomly assigned to receive pomalidomide plus low-dose Dexamethasone and 153 high-dose Dexamethasone. After a median follow-up of 10·0 months (IQR 7·2–13·2), median PFS with pomalidomide plus low-dose Dexamethasone was 4·0 months (95% CI 3·6–4·7) versus 1·9 months (1·9–2·2) with high-dose Dexamethasone (hazard ratio 0·48 [95% CI 0·39–0·60]; p<0·0001). The most common grade 3–4 haematological adverse events in the pomalidomide plus lowdose Dexamethasone and high-dose Dexamethasone groups were neutropenia (143 [48%] of 300 vs 24 [16%] of 150, respectively), anaemia (99 [33%] vs 55 [37%], respectively), and thrombocytopenia (67 [22%] vs 39 [26%], respectively). Grade 3–4 non-haematological adverse events in the pomalidomide plus low-dose Dexamethasone and high-dose Dexamethasone groups included pneumonia (38 [13%] vs 12 [8%], respectively), bone pain (21 [7%] vs seven [5%], respectively), and fatigue (16 [5%] vs nine [6%], respectively). There were 11 (4%) treatment-related adverse events leading to death in the pomalidomide plus low-dose Dexamethasone group and seven (5%) in the high-dose Dexamethasone group.
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bortezomib based versus nonbortezomib based induction treatment before autologous stem cell transplantation in patients with previously untreated multiple myeloma a meta analysis of phase iii randomized controlled trials
Journal of Clinical Oncology, 2013Co-Authors: Pieter Sonneveld, Joan Blade, Juan Jose Lahuerta, Hartmut Goldschmidt, Laura Rosinol, Michele Cavo, Paola Tacchetti, Elena Zamagni, Michel Attal, Henk M LokhorstAbstract:Purpose To characterize efficacy and safety of bortezomib-based versus nonbortezomib-based induction regimens through an integrated analysis of data from phase III studies in transplantation-eligible patients with previously untreated myeloma. Patients and Methods Patient-level data from the IFM 2005-01 (bortezomib-Dexamethasone v vincristine-doxorubicin-Dexamethasone [VAD] induction), HOVON-65/GMMG-HD4 (bortezomib-doxorubicin-Dexamethasone v VAD), and PETHEMA GEM05MENOS65 (bortezomib-thalidomide-Dexamethasone v thalidomide-Dexamethasone) studies were pooled in an integrated analysis of efficacy and safety. Study-level data from the GIMEMA MM-BO2005 study (bortezomib-thalidomide-Dexamethasone v thalidomide-Dexamethasone) supplemented the integrated patient-level analysis. Key efficacy end points were post-transplantation complete plus near-complete response (CR+nCR) rate and progression-free survival (PFS). Results Patient-level data for 1,572 patients (bortezomib-based induction, n = 787; nonbortezomib-b...
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bortezomib based versus nonbortezomib based induction treatment before autologous stem cell transplantation in patients with previously untreated multiple myeloma a meta analysis of phase iii randomized controlled trials
Journal of Clinical Oncology, 2013Co-Authors: Pieter Sonneveld, Joan Blade, Juan Jose Lahuerta, Hartmut Goldschmidt, Laura Rosinol, Michele Cavo, Paola Tacchetti, Elena Zamagni, Michel Attal, Henk M LokhorstAbstract:Purpose To characterize efficacy and safety of bortezomib-based versus nonbortezomib-based induction regimens through an integrated analysis of data from phase III studies in transplantation-eligible patients with previously untreated myeloma. Patients and Methods Patient-level data from the IFM 2005-01 (bortezomib-Dexamethasone v vincristine-doxorubicin-Dexamethasone [VAD] induction), HOVON-65/GMMG-HD4 (bortezomib-doxorubicin-Dexamethasone v VAD), and PETHEMA GEM05MENOS65 (bortezomib-thalidomide-Dexamethasone v thalidomide-Dexamethasone) studies were pooled in an integrated analysis of efficacy and safety. Study-level data from the GIMEMA MM-BO2005 study (bortezomib-thalidomide-Dexamethasone v thalidomide-Dexamethasone) supplemented the integrated patient-level analysis. Key efficacy end points were post-transplantation complete plus near-complete response (CR+nCR) rate and progression-free survival (PFS). Results Patient-level data for 1,572 patients (bortezomib-based induction, n = 787; nonbortezomib-b...
Henk M Lokhorst - One of the best experts on this subject based on the ideXlab platform.
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bortezomib based versus nonbortezomib based induction treatment before autologous stem cell transplantation in patients with previously untreated multiple myeloma a meta analysis of phase iii randomized controlled trials
Journal of Clinical Oncology, 2013Co-Authors: Pieter Sonneveld, Joan Blade, Juan Jose Lahuerta, Hartmut Goldschmidt, Laura Rosinol, Michele Cavo, Paola Tacchetti, Elena Zamagni, Michel Attal, Henk M LokhorstAbstract:Purpose To characterize efficacy and safety of bortezomib-based versus nonbortezomib-based induction regimens through an integrated analysis of data from phase III studies in transplantation-eligible patients with previously untreated myeloma. Patients and Methods Patient-level data from the IFM 2005-01 (bortezomib-Dexamethasone v vincristine-doxorubicin-Dexamethasone [VAD] induction), HOVON-65/GMMG-HD4 (bortezomib-doxorubicin-Dexamethasone v VAD), and PETHEMA GEM05MENOS65 (bortezomib-thalidomide-Dexamethasone v thalidomide-Dexamethasone) studies were pooled in an integrated analysis of efficacy and safety. Study-level data from the GIMEMA MM-BO2005 study (bortezomib-thalidomide-Dexamethasone v thalidomide-Dexamethasone) supplemented the integrated patient-level analysis. Key efficacy end points were post-transplantation complete plus near-complete response (CR+nCR) rate and progression-free survival (PFS). Results Patient-level data for 1,572 patients (bortezomib-based induction, n = 787; nonbortezomib-b...
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bortezomib based versus nonbortezomib based induction treatment before autologous stem cell transplantation in patients with previously untreated multiple myeloma a meta analysis of phase iii randomized controlled trials
Journal of Clinical Oncology, 2013Co-Authors: Pieter Sonneveld, Joan Blade, Juan Jose Lahuerta, Hartmut Goldschmidt, Laura Rosinol, Michele Cavo, Paola Tacchetti, Elena Zamagni, Michel Attal, Henk M LokhorstAbstract:Purpose To characterize efficacy and safety of bortezomib-based versus nonbortezomib-based induction regimens through an integrated analysis of data from phase III studies in transplantation-eligible patients with previously untreated myeloma. Patients and Methods Patient-level data from the IFM 2005-01 (bortezomib-Dexamethasone v vincristine-doxorubicin-Dexamethasone [VAD] induction), HOVON-65/GMMG-HD4 (bortezomib-doxorubicin-Dexamethasone v VAD), and PETHEMA GEM05MENOS65 (bortezomib-thalidomide-Dexamethasone v thalidomide-Dexamethasone) studies were pooled in an integrated analysis of efficacy and safety. Study-level data from the GIMEMA MM-BO2005 study (bortezomib-thalidomide-Dexamethasone v thalidomide-Dexamethasone) supplemented the integrated patient-level analysis. Key efficacy end points were post-transplantation complete plus near-complete response (CR+nCR) rate and progression-free survival (PFS). Results Patient-level data for 1,572 patients (bortezomib-based induction, n = 787; nonbortezomib-b...
Michel Attal - One of the best experts on this subject based on the ideXlab platform.
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isatuximab plus pomalidomide and low dose Dexamethasone versus pomalidomide and low dose Dexamethasone in patients with relapsed and refractory multiple myeloma icaria mm a randomised multicentre open label phase 3 study
The Lancet, 2019Co-Authors: Michel Attal, Ivan Spicka, Xavier Leleu, Jesus F Sanmiguel, Vincent S Rajkumar, Paul G Richardson, Meral Beksac, Fredrik Schjesvold, Philippe MoreauAbstract:Summary Background Isatuximab is a monoclonal antibody that binds a specific epitope on the human CD38 receptor and has antitumour activity via multiple mechanisms of action. In a previous phase 1b study, around 65% of patients with relapsed and refractory multiple myeloma achieved an overall response with a combination of isatuximab with pomalidomide and low-dose Dexamethasone. The aim of this study was to determine the progression-free survival benefit of isatuximab plus pomalidomide and Dexamethasone compared with pomalidomide and Dexamethasone in patients with relapsed and refractory multiple myeloma. Methods We did a randomised, multicentre, open-label, phase 3 study at 102 hospitals in 24 countries in Europe, North America, and the Asia-Pacific regions. Eligible participants were adult patients with relapsed and refractory multiple myeloma who had received at least two previous lines of treatment, including lenalidomide and a proteasome inhibitor. Patients were excluded if they were refractory to previous treatment with an anti-CD38 monoclonal antibody. We randomly assigned patients (1:1) to either isatuximab 10 mg/kg plus pomalidomide 4 mg plus Dexamethasone 40 mg (20 mg for patients aged ≥75 years), or pomalidomide 4 mg plus Dexamethasone 40 mg. Randomisation was done using interactive response technology and stratified according to the number of previous lines of treatment (2–3 vs >3) and age ( Findings Between Jan 10, 2017, and Feb 2, 2018, we randomly assigned 307 patients to treatment: 154 to isatuximab–pomalidomide–Dexamethasone, and 153 to pomalidomide–Dexamethasone. At a median follow-up of 11·6 months (IQR 10·1–13·9), median progression-free survival was 11·5 months (95% CI 8·9–13·9) in the isatuximab–pomalidomide–Dexamethasone group versus 6·5 months (4·5–8·3) in the pomalidomide–Dexamethasone group; hazard ratio 0·596, 95% CI 0·44–0·81; p=0·001 by stratified log-rank test. The most frequent treatment-emergent adverse events (any grade; isatuximab–pomalidomide–Dexamethasone vs pomalidomide–Dexamethasone) were infusion reactions (56 [38%] vs 0), upper respiratory tract infections (43 [28%] vs 26 [17%]), and diarrhoea (39 [26%] vs 29 [20%]). Adverse events with a fatal outcome were reported in 12 patients (8%) in the isatuximab–pomalidomide–Dexamethasone group and 14 (9%) in the pomalidomide–Dexamethasone group. Deaths due to treatment-related adverse events were reported for one patient ( Interpretation The addition of isatuximab to pomalidomide–Dexamethasone significantly improves progression-free survival in patients with relapsed and refractory multiple myeloma. Isatuximab is an important new treatment option for the management of relapsed and refractory myeloma, particularly for patients who become refractory to lenalidomide and a proteasome inhibitor. Funding Sanofi. Video Abstract Paul Richardson introduces the paper on isatuximab plus pomalidomide and low-dose Dexamethasone versus pomalidomide and low-dose Dexamethasone in patients with relapsed and refractory multiple myeloma as part of the ICARIA-MM study. Watch this abstract on YouTube
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bortezomib based versus nonbortezomib based induction treatment before autologous stem cell transplantation in patients with previously untreated multiple myeloma a meta analysis of phase iii randomized controlled trials
Journal of Clinical Oncology, 2013Co-Authors: Pieter Sonneveld, Joan Blade, Juan Jose Lahuerta, Hartmut Goldschmidt, Laura Rosinol, Michele Cavo, Paola Tacchetti, Elena Zamagni, Michel Attal, Henk M LokhorstAbstract:Purpose To characterize efficacy and safety of bortezomib-based versus nonbortezomib-based induction regimens through an integrated analysis of data from phase III studies in transplantation-eligible patients with previously untreated myeloma. Patients and Methods Patient-level data from the IFM 2005-01 (bortezomib-Dexamethasone v vincristine-doxorubicin-Dexamethasone [VAD] induction), HOVON-65/GMMG-HD4 (bortezomib-doxorubicin-Dexamethasone v VAD), and PETHEMA GEM05MENOS65 (bortezomib-thalidomide-Dexamethasone v thalidomide-Dexamethasone) studies were pooled in an integrated analysis of efficacy and safety. Study-level data from the GIMEMA MM-BO2005 study (bortezomib-thalidomide-Dexamethasone v thalidomide-Dexamethasone) supplemented the integrated patient-level analysis. Key efficacy end points were post-transplantation complete plus near-complete response (CR+nCR) rate and progression-free survival (PFS). Results Patient-level data for 1,572 patients (bortezomib-based induction, n = 787; nonbortezomib-b...
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bortezomib based versus nonbortezomib based induction treatment before autologous stem cell transplantation in patients with previously untreated multiple myeloma a meta analysis of phase iii randomized controlled trials
Journal of Clinical Oncology, 2013Co-Authors: Pieter Sonneveld, Joan Blade, Juan Jose Lahuerta, Hartmut Goldschmidt, Laura Rosinol, Michele Cavo, Paola Tacchetti, Elena Zamagni, Michel Attal, Henk M LokhorstAbstract:Purpose To characterize efficacy and safety of bortezomib-based versus nonbortezomib-based induction regimens through an integrated analysis of data from phase III studies in transplantation-eligible patients with previously untreated myeloma. Patients and Methods Patient-level data from the IFM 2005-01 (bortezomib-Dexamethasone v vincristine-doxorubicin-Dexamethasone [VAD] induction), HOVON-65/GMMG-HD4 (bortezomib-doxorubicin-Dexamethasone v VAD), and PETHEMA GEM05MENOS65 (bortezomib-thalidomide-Dexamethasone v thalidomide-Dexamethasone) studies were pooled in an integrated analysis of efficacy and safety. Study-level data from the GIMEMA MM-BO2005 study (bortezomib-thalidomide-Dexamethasone v thalidomide-Dexamethasone) supplemented the integrated patient-level analysis. Key efficacy end points were post-transplantation complete plus near-complete response (CR+nCR) rate and progression-free survival (PFS). Results Patient-level data for 1,572 patients (bortezomib-based induction, n = 787; nonbortezomib-b...
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bortezomib plus Dexamethasone is superior to vincristine plus doxorubicin plus Dexamethasone as induction treatment prior to autologous stem cell transplantation in newly diagnosed multiple myeloma results of the ifm 2005 01 phase iii trial
Journal of Clinical Oncology, 2010Co-Authors: Jeanluc Harousseau, Cyrille Hulin, Thierry Facon, Michel Attal, Herve Avetloiseau, Gerald Marit, Denis Caillot, Mohamad Mohty, Pascal Lenain, Philippe CasassusAbstract:Purpose To compare efficacy and safety of bortezomib plus Dexamethasone and vincristine plus doxorubicin plus Dexamethasone (VAD) as induction before stem-cell transplantation in previously untreated myeloma. Patients and Methods Four hundred eighty-two patients were randomly assigned to VAD (n 121), VAD plus Dexamethasone, cyclophosphamide, etoposide, and cisplatin (DCEP) consolidation (n 121), bortezomib plus Dexamethasone (n 121), or bortezomib plus Dexamethasone plus DCEP (n 119), followed by autologous stem-cell transplantation. Patients not achieving very good partial response (VGPR) required a second transplantation. The primary end point was postinduction complete response/near complete response (CR/nCR) rate. Results Postinduction CR/nCR (14.8% v 6.4%), at least VGPR (37.7% v 15.1%), and overall response (78.5% v 62.8%) rates were significantly higher with bortezomib plus Dexamethasone versus VAD; CR/nCR and at least VGPR rates were higher regardless of disease stage or adverse cytogenetic abnormalities. Response rates were similar in patients who did and did not receive DCEP. Post first transplantation, CR/nCR (35.0% v 18.4%) and at least VGPR (54.3% v 37.2%) rates remained significantly higher with bortezomib plus Dexamethasone. Median progression-free survival (PFS) was 36.0 months versus 29.7 months (P .064) with bortezomib plus Dexamethasone versus VAD; respective 3-year survival rates were 81.4% and 77.4% (median follow-up, 32.2 months). The incidence of severe adverse events appeared similar between groups, but hematologic toxicity and deaths related to toxicity (zero v seven) were more frequent with VAD. Conversely, rates of grade 2 (20.5% v 10.5%) and grades 3 to 4 (9.2% v 2.5%) peripheral neuropathy during induction through first transplantation were significantly higher with bortezomib plus Dexamethasone. Conclusion Bortezomib plus Dexamethasone significantly improved postinduction and post-transplantation CR/nCR and at least VGPR rates compared with VAD and resulted in a trend for longer PFS. Bortezomib plus Dexamethasone should therefore be considered a standard of care in this setting. J Clin Oncol 28:4621-4629. © 2010 by American Society of Clinical Oncology
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lenalidomide plus Dexamethasone is more effective than Dexamethasone alone in patients with relapsed or refractory multiple myeloma regardless of prior thalidomide exposure
Blood, 2008Co-Authors: Michael Wang, Michel Attal, Meletios A. Dimopoulos, Christine Chen, Teresa M Cibeira, Andrew Spencer, Vincent S Rajkumar, Marta Olesnyckyj, Jerome B Zeldis, Robert KnightAbstract:This analysis assessed the efficacy and safety of lenalidomide + Dexamethasone in patients with relapsed or refractory multiple myeloma (MM) previously treated with thalidomide. Of 704 patients, 39% were thalidomide exposed. Thalidomide-exposed patients had more prior lines of therapy and longer duration of myeloma than thalidomide-naive patients. Lenalidomide + Dexamethasone led to higher overall response rate (ORR), longer time to progression (TTP), and progression-free survival (PFS) versus placebo + Dexamethasone despite prior thalidomide exposure. Among lenalidomide + Dexamethasone-treated patients, ORR was higher in thalidomide-naive versus thalidomide-exposed patients (P = .04), with longer median TTP (P = .04) and PFS (P = .02). Likewise for Dexamethasone alone-treated patients (P = .03 for ORR, P = .03 for TTP, P = .06 for PFS). Prior thalidomide did not affect survival in lenalidomide + Dexamethasone-treated patients (36.1 vs 33.3 months, P > .05). Thalidomide-naive and thalidomide-exposed patients had similar toxicities. Lenalidomide + Dexamethasone resulted in higher rates of venous thromboembolism, myelosuppression, and infections versus placebo + Dexamethasone, independent of prior thalidomide exposure. Lenalido-mide + Dexamethasone was superior to placebo + Dexamethasone, independent of prior thalidomide exposure. Although prior thalidomide may have contributed to inferior TTP and PFS compared with thalidomide-naive patients, these parameters remained superior compared with placebo + Dexamethasone; similar benefits compared with placebo + Dexamethasone were not evident for thalidomide-exposed patients in terms of overall survival. Studies were registered at http://www.clinicaltrials.gov under NCT00056160 and NCT00424047.
Pieter Sonneveld - One of the best experts on this subject based on the ideXlab platform.
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bortezomib based versus nonbortezomib based induction treatment before autologous stem cell transplantation in patients with previously untreated multiple myeloma a meta analysis of phase iii randomized controlled trials
Journal of Clinical Oncology, 2013Co-Authors: Pieter Sonneveld, Joan Blade, Juan Jose Lahuerta, Hartmut Goldschmidt, Laura Rosinol, Michele Cavo, Paola Tacchetti, Elena Zamagni, Michel Attal, Henk M LokhorstAbstract:Purpose To characterize efficacy and safety of bortezomib-based versus nonbortezomib-based induction regimens through an integrated analysis of data from phase III studies in transplantation-eligible patients with previously untreated myeloma. Patients and Methods Patient-level data from the IFM 2005-01 (bortezomib-Dexamethasone v vincristine-doxorubicin-Dexamethasone [VAD] induction), HOVON-65/GMMG-HD4 (bortezomib-doxorubicin-Dexamethasone v VAD), and PETHEMA GEM05MENOS65 (bortezomib-thalidomide-Dexamethasone v thalidomide-Dexamethasone) studies were pooled in an integrated analysis of efficacy and safety. Study-level data from the GIMEMA MM-BO2005 study (bortezomib-thalidomide-Dexamethasone v thalidomide-Dexamethasone) supplemented the integrated patient-level analysis. Key efficacy end points were post-transplantation complete plus near-complete response (CR+nCR) rate and progression-free survival (PFS). Results Patient-level data for 1,572 patients (bortezomib-based induction, n = 787; nonbortezomib-b...
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bortezomib based versus nonbortezomib based induction treatment before autologous stem cell transplantation in patients with previously untreated multiple myeloma a meta analysis of phase iii randomized controlled trials
Journal of Clinical Oncology, 2013Co-Authors: Pieter Sonneveld, Joan Blade, Juan Jose Lahuerta, Hartmut Goldschmidt, Laura Rosinol, Michele Cavo, Paola Tacchetti, Elena Zamagni, Michel Attal, Henk M LokhorstAbstract:Purpose To characterize efficacy and safety of bortezomib-based versus nonbortezomib-based induction regimens through an integrated analysis of data from phase III studies in transplantation-eligible patients with previously untreated myeloma. Patients and Methods Patient-level data from the IFM 2005-01 (bortezomib-Dexamethasone v vincristine-doxorubicin-Dexamethasone [VAD] induction), HOVON-65/GMMG-HD4 (bortezomib-doxorubicin-Dexamethasone v VAD), and PETHEMA GEM05MENOS65 (bortezomib-thalidomide-Dexamethasone v thalidomide-Dexamethasone) studies were pooled in an integrated analysis of efficacy and safety. Study-level data from the GIMEMA MM-BO2005 study (bortezomib-thalidomide-Dexamethasone v thalidomide-Dexamethasone) supplemented the integrated patient-level analysis. Key efficacy end points were post-transplantation complete plus near-complete response (CR+nCR) rate and progression-free survival (PFS). Results Patient-level data for 1,572 patients (bortezomib-based induction, n = 787; nonbortezomib-b...
Michele Cavo - One of the best experts on this subject based on the ideXlab platform.
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lenalidomide and Dexamethasone in transplant ineligible patients with myeloma
The New England Journal of Medicine, 2014Co-Authors: Lotfi Benboubker, Michele Cavo, Meletios A. Dimopoulos, Katja Weisel, Andrew Belch, Angela Dispenzieri, John Catalano, Antonello Pinto, Heinz Ludwig, Nizar J BahlisAbstract:Background The combination melphalan–prednisone–thalidomide (MPT) is considered a standard therapy for patients with myeloma who are ineligible for stem-cell transplantation. However, emerging data on the use of lenalidomide and low-dose Dexamethasone warrant a prospective comparison of the two approaches. Methods We randomly assigned 1623 patients to lenalidomide and Dexamethasone in 28-day cycles until disease progression (535 patients), to the same combination for 72 weeks (18 cycles; 541 patients), or to MPT for 72 weeks (547 patients). The primary end point was progression-free survival with continuous lenalidomide–Dexamethasone versus MPT. Results The median progression-free survival was 25.5 months with continuous lenalidomide–Dexamethasone, 20.7 months with 18 cycles of lenalidomide–Dexamethasone, and 21.2 months with MPT (hazard ratio for the risk of progression or death, 0.72 for continuous lenalidomide–Dexamethasone vs. MPT and 0.70 for continuous lenalidomide–Dexamethasone vs. 18 cycles of len...
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bortezomib based versus nonbortezomib based induction treatment before autologous stem cell transplantation in patients with previously untreated multiple myeloma a meta analysis of phase iii randomized controlled trials
Journal of Clinical Oncology, 2013Co-Authors: Pieter Sonneveld, Joan Blade, Juan Jose Lahuerta, Hartmut Goldschmidt, Laura Rosinol, Michele Cavo, Paola Tacchetti, Elena Zamagni, Michel Attal, Henk M LokhorstAbstract:Purpose To characterize efficacy and safety of bortezomib-based versus nonbortezomib-based induction regimens through an integrated analysis of data from phase III studies in transplantation-eligible patients with previously untreated myeloma. Patients and Methods Patient-level data from the IFM 2005-01 (bortezomib-Dexamethasone v vincristine-doxorubicin-Dexamethasone [VAD] induction), HOVON-65/GMMG-HD4 (bortezomib-doxorubicin-Dexamethasone v VAD), and PETHEMA GEM05MENOS65 (bortezomib-thalidomide-Dexamethasone v thalidomide-Dexamethasone) studies were pooled in an integrated analysis of efficacy and safety. Study-level data from the GIMEMA MM-BO2005 study (bortezomib-thalidomide-Dexamethasone v thalidomide-Dexamethasone) supplemented the integrated patient-level analysis. Key efficacy end points were post-transplantation complete plus near-complete response (CR+nCR) rate and progression-free survival (PFS). Results Patient-level data for 1,572 patients (bortezomib-based induction, n = 787; nonbortezomib-b...
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bortezomib based versus nonbortezomib based induction treatment before autologous stem cell transplantation in patients with previously untreated multiple myeloma a meta analysis of phase iii randomized controlled trials
Journal of Clinical Oncology, 2013Co-Authors: Pieter Sonneveld, Joan Blade, Juan Jose Lahuerta, Hartmut Goldschmidt, Laura Rosinol, Michele Cavo, Paola Tacchetti, Elena Zamagni, Michel Attal, Henk M LokhorstAbstract:Purpose To characterize efficacy and safety of bortezomib-based versus nonbortezomib-based induction regimens through an integrated analysis of data from phase III studies in transplantation-eligible patients with previously untreated myeloma. Patients and Methods Patient-level data from the IFM 2005-01 (bortezomib-Dexamethasone v vincristine-doxorubicin-Dexamethasone [VAD] induction), HOVON-65/GMMG-HD4 (bortezomib-doxorubicin-Dexamethasone v VAD), and PETHEMA GEM05MENOS65 (bortezomib-thalidomide-Dexamethasone v thalidomide-Dexamethasone) studies were pooled in an integrated analysis of efficacy and safety. Study-level data from the GIMEMA MM-BO2005 study (bortezomib-thalidomide-Dexamethasone v thalidomide-Dexamethasone) supplemented the integrated patient-level analysis. Key efficacy end points were post-transplantation complete plus near-complete response (CR+nCR) rate and progression-free survival (PFS). Results Patient-level data for 1,572 patients (bortezomib-based induction, n = 787; nonbortezomib-b...