GRACIA APARECIDA MARTINEZ

(Fonte: Lattes)
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Instituto Central, Hospital das Clínicas, Faculdade de Medicina - Médico
LIM/31 - Laboratório de Genética e Hematologia Molecular, Hospital das Clínicas, Faculdade de Medicina

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  • conferenceObject
    Isatuximab Plus Carfilzomib and Dexamethasone in Relapsed Multiple Myeloma: Ikema Subgroup Analysis By Number of Prior Lines of Treatment
    (2022) CAPRA, Marcelo; MARTIN, Thomas; MOREAU, Philippe; MARTINEZ, Gracia; ORIOL, Albert; KOH, Youngil; QUACH, Hang; YONG, Kwee; RAWLINGS, Andreea; TEKLE, Christina; MACE, Sandrine; RISSE, Marie-Laure; SPICKA, Ivan
  • article 18 Citação(ões) na Scopus
    Isatuximab, carfilzomib, and dexamethasone in patients with relapsed multiple myeloma: updated results from IKEMA, a randomized Phase 3 study
    (2023) MARTIN, Thomas; DIMOPOULOS, Meletios-Athanasios; MIKHAEL, Joseph; YONG, Kwee; CAPRA, Marcelo; FACON, Thierry; HAJEK, Roman; SPICKA, Ivan; BAKER, Ross; KIM, Kihyun; MARTINEZ, Gracia; MIN, Chang-Ki; POUR, Ludek; LELEU, Xavier; ORIOL, Albert; KOH, Youngil; SUZUKI, Kenshi; CASCA, France; MACE, Sandrine; RISSE, Marie-Laure; MOREAU, Philippe
    Longer-term outcomes with the anti-CD38 antibody isatuximab in combination with carfilzomib-dexamethasone (Isa-Kd) were evaluated in the randomized Phase 3 trial IKEMA (NCT03275285), in a prespecified, follow-up analysis of progression-free survival (PFS, primary study endpoint), final complete response (CR) using Hydrashift Isa immunofixation assay, minimal residual disease (MRD) negativity, and safety. Enrolled patients had relapsed/refractory multiple myeloma (1-3 prior treatment lines). Isa 10 mg/kg was administered intravenously weekly in cycle 1 then biweekly. Efficacy analyses were performed in the intent-to-treat population (Isa-Kd: n = 179, Kd: n = 123) and safety evaluated in treated patients (Isa-Kd: n = 177, Kd: n = 122). Consistent with the primary interim analysis, the addition of Isa to Kd prolonged PFS (HR 0.58, 95.4% CI: 0.42-0.79; median PFS 35.7 [95% CI: 25.8-44.0] vs 19.2 [95% CI: 15.8-25.0] months). PFS benefit was observed with Isa-Kd across subgroups, including patients with poor prognosis. The stringent CR/CR rate was 44.1% vs 28.5% (odds-ratio: 2.09, 95% CI: 1.26-3.48), the MRD negativity rate 33.5% vs 15.4% (odds-ratio: 2.78, 95% CI: 1.55-4.99) and the MRD negativity CR rate 26.3% vs 12.2%, with Isa-Kd vs Kd. The safety profile of Isa-Kd was similar to that reported in the prior interim analysis. These findings further support Isa-Kd as a standard-of-care treatment for relapsed multiple myeloma patients.
  • article 180 Citação(ões) na Scopus
    Isatuximab, carfilzomib, and dexamethasone in relapsed multiple myeloma (IKEMA): a multicentre, open-label, randomised phase 3 trial
    (2021) MOREAU, Philippe; DIMOPOULOS, Meletios-Athanasios; MIKHAEL, Joseph; YONG, Kwee; CAPRA, Marcelo; FACON, Thierry; HAJEK, Roman; SPICKA, Ivan; BAKER, Ross; KIM, Kihyun; MARTINEZ, Gracia; MIN, Chang-Ki; POUR, Ludek; LELEU, Xavier; ORIOL, Albert; KOH, Youngil; SUZUKI, Kenshi; RISSE, Marie-Laure; ASSET, Gaelle; MACE, Sandrine; MARTIN, Thomas
    Background Isatuximab is an anti-CD38 monoclonal antibody approved in combination with pomalidomide-dexamethasone and carfilzomib-dexamethasone for relapsed or refractory multiple myeloma. This phase 3, openlabel study compared the efficacy of isatuximab plus carfilzomib-dexamethasone versus carfilzomib-dexamethasone in patients with relapsed multiple rnyeloma. Methods This was a prospective, randomised, open-label, parallel-group, phase 3 study done at 69 study centres in 16 countries across North America, South America, Europe, and the Asia-Pacific region. Patients with relapsed or refractory multiple rnyelorna aged at least 18 years who had received one to three previous lines of therapy and had measurable serum or urine M-protein were eligible. Patients were randomly assigned (3:2) to isatuximab plus carfilzomib-dexamethasone (isatuximab group) or carfilzomib-dexamethasone (control group). Patients in the isatuximab group received isatuximab 10 mg/kg intravenously weekly for the first 4 weeks, then every 2 weeks. Both groups received time approved schedule of intravenous carfilzomib and oral or intravenous dexamethasone. Treatment continued until progression or unacceptable toxicity. The primary endpoint was progression-free survival and was assessed in the intention-to-treat population according to assigned treatment. Safety was assessed in all patients who received at least one dose according to treatment received. The study is registered at ClinicalTrials.gov, NCT03275285. Findings Between Nov 15,2017, and March 21,2019,302 patients with a median of two previous lines of therapy were enrolled. 179 were randomly assigned to the isatuximab group and 123 to the control group. Median progression-free survival was not reached in the isatuximab group compared with 19.15 months (95% CI 15.77-not reached) in the control group, with a hazard ratio of 0.53 (99% CI 0.32-0-89; one-sided p=0-0007). Treatment-emergent adverse events (TEAEs) of grade 3 or worse occurred in 136 (77%) of 177 patients in the isatuximab group versus 82 (67%) of 122 in the control group, serious TEAEs occurred in 105 (59%) versus 70 (57%) patients, and TEA Es led to discontinuation in 15 (8%) versus 17 (14%) patients. Fatal TEA Es during study treatment occurred in six (3%) versus four (3%) patients. Interpretation The addition of isatuximab to carfilzomib-dexamethasone significantly improves progression-free survival and depth of response in patients with relapsed multiple myeloma, representing a new standard of care for this patient population.
  • conferenceObject
    Isatuximab plus carfilzomib and dexamethasone versus carfilzomib and dexamethasone in patients with relapsed multiple myeloma (IKEMA): final overall survival analysis
    (2023) YONG, Kwee; MARTIN, Thomas; DIMOPOULOS, Meletios; MIKHAEL, Joseph; CAPRA, Marcelo; FACON, Thierry; HAJEK, Roman; SPICKA, Ivan; BAKER, Ross; KIM, Kihyun; MARTINEZ, Gracia; MIN, Chang-Ki; POUR, Ludek; LELEU, Xavier; ORIOL, Albert; KOH, Youngil; SUZUKI, Kenshi; CASCA, France; MACE, Sandrine; RISSE, Marie-Laure; MOREAU, Philippe
  • article 0 Citação(ões) na Scopus
    Isatuximab, carfilzomib, and dexamethasone in patients with relapsed multiple myeloma: updated results from IKEMA, a randomized Phase 3 study (vol 13, 152, 2023)
    (2023) MARTIN, Thomas; DIMOPOULOS, Meletios-Athanasios; MIKHAEL, Joseph; YONG, Kwee; CAPRA, Marcelo; FACON, Thierry; HAJEK, Roman; SPICKA, Ivan; BAKER, Ross; KIM, Kihyun; MARTINEZ, Gracia; MIN, Chang-Ki; POUR, Ludek; LELEU, Xavier; ORIOL, Albert; KOH, Youngil; SUZUKI, Kenshi; CASCA, France; MACE, Sandrine; RISSE, Marie-Laure; MOREAU, Philippe
  • article 9 Citação(ões) na Scopus
    Isatuximab plus carfilzomib and dexamethasone in relapsed multiple myeloma patients with high-risk cytogenetics: IKEMA subgroup analysis
    (2022) SPICKA, Ivan; MOREAU, Philippe; MARTIN, Thomas G.; FACON, Thierry; MARTINEZ, Gracia; ORIOL, Albert; KOH, Youngil; LIM, Andrew; MIKALA, Gabor; ROSINOL, Laura; YAGCI, Munci; CAVO, Michele; RISSE, Marie-Laure; ASSET, Gaelle; MACE, Sandrine; VELDE, Helgi van de; YONG, Kwee
    Introduction The presence of high-risk chromosomal abnormalities [t(4;14), del(17p), and t(14;16)] has been linked with inferior outcomes in patients with multiple myeloma (MM). A prespecified interim analysis of the Phase 3 IKEMA study (NCT03275285) demonstrated that isatuximab (Isa) + carfilzomib (K) and dexamethasone (d; Isa-Kd) significantly improved progression-free survival (PFS) versus Kd in patients with relapsed MM. This prespecified subgroup analysis of IKEMA examined efficacy and safety in patients with high-risk cytogenetics. Methods High-risk cytogenetics was assessed by central laboratory and patients were classified as high risk if abnormalities were present in >= 1 of the following: del(17p): 50% cutoff; t(4;14), and/or t(14;16): 30% cutoff. Results Of the randomized patients, 23.5% (Isa-Kd) and 25.2% (Kd) had >= 1 high-risk chromosomal abnormality. A PFS benefit was seen in favor of Isa-Kd for patients with standard-risk (HR 0.440; 95% CI 0.266-0.728) and high-risk cytogenetics (HR 0.724; 95% CI 0.361-1.451). Grade >= 3 treatment-emergent adverse events (TEAEs) were more common with Isa-Kd (85.7%) versus Kd (63.3%) in patients with high-risk cytogenetics; however, the incidence of serious TEAEs (64.3% vs. 66.7%) was similar. Conclusions Isa-Kd is a new treatment option for the difficult-to-treat subgroup of patients with relapsed MM and high-risk cytogenetics.