9 results on '"San-Miguel, J."'
Search Results
2. Pembrolizumab combined with carfilzomib and low-dose dexamethasone for relapsed or refractory multiple myeloma: Cohort 2 of the phase I KEYNOTE-023 study.
- Author
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Moreau P, Ghori R, Farooqui M, Marinello P, and San Miguel J
- Subjects
- Acute Kidney Injury chemically induced, Adolescent, Adult, Aged, Antibodies, Monoclonal, Humanized administration & dosage, Antibodies, Monoclonal, Humanized adverse effects, Antineoplastic Combined Chemotherapy Protocols adverse effects, Chemical and Drug Induced Liver Injury etiology, Dexamethasone administration & dosage, Dexamethasone adverse effects, Female, Humans, Hypopituitarism chemically induced, Male, Middle Aged, Multiple Organ Failure etiology, Oligopeptides administration & dosage, Oligopeptides adverse effects, Recurrence, Treatment Outcome, Young Adult, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Multiple Myeloma drug therapy, Salvage Therapy
- Published
- 2021
- Full Text
- View/download PDF
3. Health-related quality of life in patients with relapsed or refractory multiple myeloma: treatment with daratumumab, lenalidomide, and dexamethasone in the phase 3 POLLUX trial.
- Author
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Plesner T, Dimopoulos MA, Oriol A, San-Miguel J, Bahlis NJ, Rabin N, Suzuki K, Yoon SS, Ben-Yehuda D, Cook G, Goldschmidt H, Grosicki S, Qin X, Fastenau J, Garvin W, Carson R, Renaud T, and Gries KS
- Subjects
- Adult, Aged, Antibodies, Monoclonal administration & dosage, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Dexamethasone administration & dosage, Female, Humans, Lenalidomide administration & dosage, Male, Middle Aged, Multiple Myeloma psychology, Pain Measurement, Patient Reported Outcome Measures, Progression-Free Survival, Quality of Life, Recurrence, Surveys and Questionnaires, Treatment Outcome, Multiple Myeloma drug therapy, Salvage Therapy psychology
- Abstract
In the phase 3 POLLUX trial, daratumumab in combination with lenalidomide and dexamethasone (D-Rd) significantly improved progression-free survival in patients with relapsed/refractory multiple myeloma (RRMM) compared with lenalidomide and dexamethasone (Rd) alone. Here, we present patient-reported outcomes (PROs) from POLLUX, assessed using the validated European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) and the EuroQol 5-dimensional descriptive system (EQ-5D-5L) questionnaires. Changes from baseline are presented as least-squares mean changes with 95% confidence intervals (CIs) derived from a mixed-effects model. PRO assessment compliance rates were high and similar in both D-Rd and Rd groups through cycle 40 (week 156). In this on-treatment analysis, mean changes from baseline were significantly greater in EORTC QLQ-C30 global health status, physical functioning, and pain scores in the D-Rd group versus the Rd group at multiple time points; however, magnitude of changes was low, suggesting no meaningful impact on health-related quality of life (HRQoL). Subgroup results were similar to those in the overall population. In the POLLUX study, baseline HRQoL was maintained with prolonged D-Rd treatment. These findings complement the sustained and significant improvement in progression-free survival observed with D-Rd and supports its use in patients with RRMM. Clinical trial registration: NCT02076009., (© 2021 British Society for Haematology and John Wiley & Sons Ltd.)
- Published
- 2021
- Full Text
- View/download PDF
4. Comparison of efficacy from two different dosing regimens of bortezomib: an exposure-response analysis.
- Author
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Parasrampuria DA, He J, Zhang L, Muresan B, Hu P, Nemat S, Hashim M, Lam A, Appiani C, Cavo M, Dimopoulos MA, San-Miguel J, and Mateos MV
- Subjects
- Aged, Aged, 80 and over, Antibodies, Monoclonal administration & dosage, Antineoplastic Combined Chemotherapy Protocols adverse effects, Bortezomib adverse effects, Clinical Trials, Phase III as Topic statistics & numerical data, Dose-Response Relationship, Drug, Drug Administration Schedule, Female, Humans, Kaplan-Meier Estimate, Logistic Models, Male, Melphalan administration & dosage, Middle Aged, Multicenter Studies as Topic statistics & numerical data, Prednisone administration & dosage, Progression-Free Survival, Proportional Hazards Models, Proteasome Inhibitors adverse effects, Proteasome Inhibitors therapeutic use, Randomized Controlled Trials as Topic statistics & numerical data, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Bortezomib administration & dosage, Multiple Myeloma drug therapy, Proteasome Inhibitors administration & dosage
- Abstract
Bortezomib is a first-in-class proteasome inhibitor, approved for the treatment of multiple myeloma. The originally approved dosing schedule of bortezomib results in significant toxicities that require dose interruptions and discontinuations. Consequentially, less frequent dosing has been explored to optimise bortezomib's benefit-risk profile. Here, we performed exposure-response analysis to compare the efficacy of the original bortezomib dosing regimen with less frequent dosing of bortezomib over nine 6-week treatment cycles using data from the VISTA clinical trial and the control arm of the ALCYONE clinical trial. The relationship between cumulative bortezomib dose and clinical response was evaluated with a univariate logit model. The median cumulative bortezomib dose was higher in ALCYONE versus VISTA (42·2 vs. 38·5 mg/m
2 ) and ALCYONE patients stayed on treatment longer (mean: 7·2 vs. 5·8 cycles). For all endpoints and regimens, probability of clinical response correlated with cumulative bortezomib dose. Similar to results observed for VISTA, overall survival was longer in ALCYONE patients with ≥ 39·0 versus < 39·0 mg/m2 cumulative dose (hazard ratio, 0·119; P < 0·0001). Less frequent bortezomib dosing results in comparable efficacy, and a higher cumulative dose than the originally approved bortezomib dosing schedule, which may be in part be due to reduced toxicity and fewer dose reductions/interruptions., (© 2020 British Society for Haematology and John Wiley & Sons Ltd.)- Published
- 2020
- Full Text
- View/download PDF
5. Pembrolizumab combined with lenalidomide and low-dose dexamethasone for relapsed or refractory multiple myeloma: phase I KEYNOTE-023 study.
- Author
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Mateos MV, Orlowski RZ, Ocio EM, Rodríguez-Otero P, Reece D, Moreau P, Munshi N, Avigan DE, Siegel DS, Ghori R, Farooqui MZH, Marinello P, and San-Miguel J
- Subjects
- Antibodies, Monoclonal, Humanized pharmacology, Dexamethasone pharmacology, Female, Humans, Lenalidomide pharmacology, Male, Middle Aged, Multiple Myeloma pathology, Antibodies, Monoclonal, Humanized therapeutic use, Dexamethasone therapeutic use, Lenalidomide therapeutic use, Multiple Myeloma drug therapy
- Published
- 2019
- Full Text
- View/download PDF
6. Elotuzumab plus lenalidomide/dexamethasone for relapsed or refractory multiple myeloma: ELOQUENT-2 follow-up and post-hoc analyses on progression-free survival and tumour growth.
- Author
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Dimopoulos MA, Lonial S, White D, Moreau P, Palumbo A, San-Miguel J, Shpilberg O, Anderson K, Grosicki S, Spicka I, Walter-Croneck A, Magen H, Mateos MV, Belch A, Reece D, Beksac M, Bleickardt E, Poulart V, Sheng J, Sy O, Katz J, Singhal A, and Richardson P
- Subjects
- Aged, Antibodies, Monoclonal, Humanized administration & dosage, Antibodies, Monoclonal, Humanized adverse effects, Antineoplastic Combined Chemotherapy Protocols adverse effects, Dexamethasone administration & dosage, Dexamethasone adverse effects, Female, Follow-Up Studies, Humans, Immunoglobulins blood, Kaplan-Meier Estimate, Lenalidomide, Male, Middle Aged, Multiple Myeloma pathology, Recurrence, Thalidomide administration & dosage, Thalidomide adverse effects, Thalidomide analogs & derivatives, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Multiple Myeloma drug therapy
- Abstract
The randomized phase III ELOQUENT-2 study (NCT01239797) evaluated the efficacy and safety of elotuzumab + lenalidomide/dexamethasone (ELd) versus lenalidomide/dexamethasone (Ld) in relapsed/refractory multiple myeloma. ELd reduced the risk of disease progression/death by 30% versus Ld (hazard ratio [HR] 0·70). Median time from diagnosis was 3·5 years. We present extended 3-year follow-up data. Endpoints included progression-free survival (PFS), overall response rate (ORR) and interim overall survival (OS). Exploratory post-hoc analyses included impact of time from diagnosis and prior lines of therapy on PFS, and serum M-protein dynamic modelling. ORR was 79% (ELd) and 66% (Ld) (P = 0·0002). ELd reduced the risk of disease progression/death by 27% versus Ld (HR 0·73; P = 0·0014). Interim OS demonstrated a trend in favour of ELd (P = 0·0257); 1-, 2- and 3-year rates with ELd versus Ld were: 91% versus 83%, 73% versus 69% and 60% versus 53%. In patients with ≥ median time from diagnosis and one prior therapy, ELd resulted in a 53% reduction in the risk of progression/death versus Ld (HR 0·47). Serum M-protein dynamic modelling showed slower tumour regrowth with ELd. Adverse events were comparable between arms. ELd provided a durable and clinically relevant improvement in efficacy, with minimal incremental toxicity., (© 2017 John Wiley & Sons Ltd.)
- Published
- 2017
- Full Text
- View/download PDF
7. Carfilzomib, lenalidomide, and dexamethasone in patients with relapsed multiple myeloma categorised by age: secondary analysis from the phase 3 ASPIRE study.
- Author
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Dimopoulos MA, Stewart AK, Masszi T, Špička I, Oriol A, Hájek R, Rosiñol L, Siegel D, Mihaylov GG, Goranova-Marinova V, Rajnics P, Suvorov A, Niesvizky R, Jakubowiak A, San-Miguel J, Ludwig H, Palumbo A, Obreja M, Aggarwal S, and Moreau P
- Subjects
- Adult, Age Factors, Aged, Aged, 80 and over, Dexamethasone administration & dosage, Female, Humans, Kaplan-Meier Estimate, Lenalidomide, Male, Middle Aged, Oligopeptides administration & dosage, Recurrence, Thalidomide administration & dosage, Thalidomide analogs & derivatives, Treatment Outcome, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Multiple Myeloma drug therapy
- Abstract
A primary analysis of the ASPIRE study found that the addition of carfilzomib to lenalidomide and dexamethasone (carfilzomib group) significantly improved progression-free survival (PFS) compared with lenalidomide and dexamethasone alone (control group) in patients with relapsed multiple myeloma (RMM). This post hoc analysis examined outcomes from ASPIRE in patients categorised by age. In the carfilzomib group, 103/396 patients were ≥70 years old, and in the control group, 115/396 patients were ≥70 years old. Median PFS for patients <70 years old was 28·6 months for the carfilzomib group versus 17·6 months for the control group [hazard ratio (HR), 0·701]. Median PFS for patients ≥70 years old was 23·8 months for the carfilzomib group versus 16·0 months for the control group (HR, 0·753). For patients <70 years the overall response rate (ORR) was 86·0% (carfilzomib group) and 66·9% (control group); for patients ≥70 years old the ORR was 90·3% (carfilzomib group) and 66·1% (control group). Within the carfilzomib group, grade ≥3 cardiovascular adverse events occurred more frequently among patients ≥70 years old compared with patients <70 years old. Carfilzomib-lenalidomide-dexamethasone has a favourable benefit-risk profile for patients with RMM, including elderly patients ≥70 years old., Trial Registration: clinicaltrials.gov identifier: NCT01080391., (© 2017 The Authors. British Journal of Haematology published by John Wiley & Sons Ltd.)
- Published
- 2017
- Full Text
- View/download PDF
8. Elotuzumab in combination with thalidomide and low-dose dexamethasone: a phase 2 single-arm safety study in patients with relapsed/refractory multiple myeloma.
- Author
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Mateos MV, Granell M, Oriol A, Martinez-Lopez J, Blade J, Hernandez MT, Martín J, Gironella M, Lynch M, Bleickardt E, Paliwal P, Singhal A, and San-Miguel J
- Subjects
- Aged, Aged, 80 and over, Antibodies, Monoclonal, Humanized administration & dosage, Antineoplastic Combined Chemotherapy Protocols adverse effects, Dexamethasone administration & dosage, Drug Resistance, Neoplasm, Female, Humans, Male, Middle Aged, Multiple Myeloma mortality, Neoplasm Staging, Recurrence, Retreatment, Survival Analysis, Thalidomide administration & dosage, Treatment Outcome, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Multiple Myeloma drug therapy, Multiple Myeloma pathology
- Abstract
Elotuzumab is an immunostimulatory, humanized immunoglobulin G1 monoclonal antibody that selectively targets and kills signalling lymphocytic activation molecule family member 7-expressing myeloma cells. We evaluated the safety and tolerability of elotuzumab 10 mg/kg combined with thalidomide 50-200 mg and dexamethasone 40 mg (with/without cyclophosphamide 50 mg) in patients with relapsed/refractory multiple myeloma (RRMM). The primary endpoint was the proportion of grade ≥3 non-haematological adverse events (AEs); other endpoints included the number of dose reductions/discontinuations and efficacy. Forty patients were treated, who had a median of three previous therapies, including bortezomib (98%) and lenalidomide (73%). Grade ≥3 non-haematological AEs were reported in 63% of patients, most commonly asthenia (35%) and peripheral oedema (25%). Six (15%) patients had an infusion reaction. Twenty-six (65%) patients had ≥1 dose reduction/discontinuation due to an AE, none related to elotuzumab. Overall response rate was 38%; median progression-free survival was 3·9 months. Median overall survival was 16·3 months and the 1-year survival rate was 63%. Minimal incremental toxicity was observed with addition of elotuzumab to thalidomide/dexamethasone with or without cyclophosphamide, and efficacy data suggest clinical benefit in a highly pre-treated population. Elotuzumab combined with thalidomide may provide an additional treatment option for patients with RRMM., (© 2016 John Wiley & Sons Ltd.)
- Published
- 2016
- Full Text
- View/download PDF
9. Phase I/II study of weekly PM00104 (Zalypsis®) in patients with relapsed/refractory multiple myeloma.
- Author
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Ocio EM, Oriol A, Bladé J, Teruel AI, Martín J, de la Rubia J, Gutiérrez NC, Rodríguez Díaz-Pavón J, Martínez González S, Coronado C, Fernández-García EM, Siguero Gómez M, Fernández-Teruel C, and San Miguel J
- Subjects
- Adult, Aged, Drug Resistance, Female, Humans, Infusions, Intravenous, Male, Maximum Tolerated Dose, Middle Aged, Recurrence, Antineoplastic Agents administration & dosage, Multiple Myeloma drug therapy, Tetrahydroisoquinolines administration & dosage
- Published
- 2016
- Full Text
- View/download PDF
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