A5084017417- Multiple Myeloma Research and Treatments
- Peptidase Inhibition and Analysis
- Chronic Lymphocytic Leukemia Research
- Myeloproliferative Neoplasms: Diagnosis and Treatment
- Protein Degradation and Inhibitors
- Cancer Treatment and Pharmacology
- Cancer Mechanisms and Therapy
- Monoclonal and Polyclonal Antibodies Research
- Chronic Myeloid Leukemia Treatments
- Cancer therapeutics and mechanisms
- Amyloidosis: Diagnosis, Treatment, Outcomes
- Synthesis and Biological Evaluation
- Research on Leishmaniasis Studies
- Cholangiocarcinoma and Gallbladder Cancer Studies
- Colorectal Cancer Treatments and Studies
- Lung Cancer Research Studies
- Neutropenia and Cancer Infections
- HIV/AIDS drug development and treatment
- Metastasis and carcinoma case studies
- Pancreatic and Hepatic Oncology Research
- Gastric Cancer Management and Outcomes
- Microtubule and mitosis dynamics
- HER2/EGFR in Cancer Research
- Glycosylation and Glycoproteins Research
- Malaria Research and Control
Sanofi (France)
2012-2024
Providence College
2023
Università Cattolica del Sacro Cuore
2005
Greater Poland Cancer Center
2005
Semmelweis University
2005
Markusovszky Egyetemi Oktatókórház
2005
Klinikum rechts der Isar
2005
Ege University
2005
Centrum Onkologii
2005
Institut Gustave Roussy
2000-2003
Longer-term outcomes with the anti-CD38 antibody isatuximab in combination carfilzomib-dexamethasone (Isa-Kd) were evaluated randomized Phase 3 trial IKEMA (NCT03275285), 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). 10 mg/kg was...
Although the treatment of relapsed/refractory multiple myeloma has improved dramatically over past decade, disease remains incurable; therefore, additional therapies are needed. Novel combination incorporating monoclonal antibodies have shown significant promise. Here we describe design a Phase III study (NCT03275285, IKEMA), which is evaluating isatuximab plus carfilzomib and low-dose dexamethasone, versus carfilzomib/dexamethasone in myeloma. The primary end point progression-free...
Treatment for relapsed/refractory multiple myeloma (RRMM) remains an unmet need. Isatuximab, anti-CD38 monoclonal antibody has shown efficacy and tolerability as a monotherapy combination therapy in Phase I/II studies RRMM. Here, we describe the design of III ICARIA-MM study (NCT02990338) which will evaluate isatuximab with pomalidomide (Pom) low-dose dexamethasone (dex) (Pom/dex) versus Pom/dex alone Patients be randomized 1:1 ratio. The primary endpoint is progression-free survival....
A phase I study was performed to determine the maximum-tolerated dose (MTD) and safety profile of irinotecan (CPT-11) administered as a single intravenous infusion every 3 weeks in children with recurrent or refractory solid tumors.Eighty-one patients were enrolled, including 48 less heavily, 33 heavily pretreated (cranial irradiation and/or high-dose chemotherapy). Children received CPT-11 120-minute at doses ranging from 200 720 mg/m2. The dose-limiting toxicities (DLT) on first cycle...
Summary Treatment benefit in multiple myeloma (MM) patients with high‐risk cytogenetics remains suboptimal. The phase 3 ICARIA‐MM trial (NCT02990338) showed that isatuximab plus pomalidomide–dexamethasone prolongs median progression‐free survival (mPFS) relapsed/refractory MM (RRMM). This subgroup analysis of compared the [defined by presence del(17p), t(4;14) or t(14;16)] versus standard‐risk patients. efficacy gain(1q21) abnormality was also assessed a retrospective analysis. In ICARIA‐MM,...
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Abstract 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 multiple myeloma (MM). A prespecified interim analysis the Phase 3 IKEMA study (NCT03275285) demonstrated that isatuximab (Isa) + carfilzomib (K) dexamethasone (d; Isa‐Kd) significantly improved progression‐free survival (PFS) versus Kd relapsed MM. This subgroup examined efficacy safety cytogenetics. Methods High‐risk cytogenetics was...
Renal impairment (RI) is common in patients with multiple myeloma (MM) and new therapies that can improve renal function are needed. The phase III IKEMA study (clinicaltrials gov. Identifier: NCT03275285) investigated isatuximab (Isa) carfilzomib dexamethasone (Kd) versus Kd relapsed MM. This subgroup analysis examined results from RI, defined as estimated glomerular filtration rate <60 mL/min/1.73 m². Addition of Isa prolonged progression-free survival (PFS) RI (hazard ratio: 0.27; 95%...
Patients with multiple myeloma (MM) who experience early relapse within 12 months of therapy initiation are considered functional high-risk and represent an unmet need, needing better therapies to improve outcomes. The final IKEMA (clinicaltrials gov. identifier: NCT03275285) progression-free survival (PFS) analysis confirmed the significant PFS improvement reported at interim isatuximab (Isa) plus carfilzomib dexamethasone (Kd; Isa-Kd) versus Kd in patients relapsed MM (updated median PFS:...
Abstract Gain/amplification of 1q21 (≥3 copies), a chromosomal abnormality frequently observed in multiple myeloma, can negatively affect prognosis, due to its involvement resistance anti‐myeloma therapy and disease progression. In this updated subgroup analysis the randomized, Phase 3 IKEMA study (NCT03275285) relapsed/refractory myeloma (RRMM), we evaluated progression‐free survival (PFS) depth response with anti‐CD38 antibody isatuximab plus carfilzomib‐dexamethasone (Isa‐Kd) versus Kd,...
<b><i>Background:</i></b> This open-label, randomized phase III trial evaluated larotaxel/cisplatin versus gemcitabine/cisplatin as first-line treatment for locally advanced (T4b) or metastatic urothelial tract bladder cancer. <b><i>Methods:</i></b> Patients were to larotaxel 50 mg/m<sup>2</sup> with cisplatin 75 every 3 weeks (larotaxel/cisplatin) gemcitabine 1,000 on days 1, 8, and 15 70 day 1 4 (gemcitabine/cisplatin). The...
Abstract The IKEMA study (Randomized, Open Label, Multicenter Study Assessing the Clinical Benefit of Isatuximab Combined With Carfilzomib [Kyprolis®] and Dexamethasone Versus in Patients Relapse and/or Refractory Multiple Myeloma Previously Treated 1 to 3 Prior Lines; #NCT03275285) was a randomized, open-label, multicenter phase investigating isatuximab plus carfilzomib dexamethasone (Isa-Kd) vs Kd patients with relapsed multiple myeloma. This subanalysis analyzed depth response Isa-Kd Kd....
In this subgroup analysis of the randomized, Phase 3 IKEMA study (NCT03275285), we evaluated efficacy and safety anti-CD38 monoclonal antibody isatuximab (Isa) in combination with carfilzomib-dexamethasone (Isa-Kd) versus Kd older (≥70 years age, n = 86) younger (<70 years, 216) patients relapsed multiple myeloma (MM). Patients received Isa 10 mg/kg intravenously weekly for 4 weeks, then every 2 weeks Isa-Kd arm, approved schedule carfilzomib (twice weekly) dexamethasone both arms. Primary...
PURPOSE: We conducted a phase I and pharmacokinetic study of docetaxel in combination with irinotecan to determine the dose-limiting toxicity (DLT), maximum-tolerated dose (MTD), at which least 50% patients experienced DLT during first cycle, evaluate safety profiles advanced solid tumors. PATIENTS AND METHODS: Patients only one prior chemotherapy treatment (without taxanes or topoisomerase inhibitors) for disease were included study. Docetaxel was administered as 1-hour IV infusion after...