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View article: Improving Advanced-Line Multiple Myeloma Care: Insights and Real-World Challenges from the EMMY Study
Improving Advanced-Line Multiple Myeloma Care: Insights and Real-World Challenges from the EMMY Study Open
Managing multiple myeloma (MM) patients receiving advanced (four or more) lines of treatment is a complex challenge. Therefore, real-world data are essential to better understand and address the medical need of this challenging population.…
View article: Isatuximab, lenalidomide, dexamethasone and bortezomib in transplant-ineligible multiple myeloma: the randomized phase 3 BENEFIT trial
Isatuximab, lenalidomide, dexamethasone and bortezomib in transplant-ineligible multiple myeloma: the randomized phase 3 BENEFIT trial Open
CD38-targeting immunotherapy is approved in combination with lenalidomide and dexamethasone in patients with newly diagnosed multiple myeloma (NDMM) that are transplant ineligible (TI) and is considered the best standard of care (SOC). To …
Value-based comparison of ambulatory children with respiratory diseases in an emergency department and a walk-in clinic: a retrospective cohort study in Québec, Canada Open
Objective To compare health outcomes and costs given in the emergency department (ED) and walk-in clinics for ambulatory children presenting with acute respiratory diseases. Design A retrospective cohort study. Setting This study was condu…
Quality of reporting of adverse events in clinical trials of covid-19 drugs: systematic review Open
Objective To assess the quality of reporting of adverse events in clinical trials of covid-19 drugs based on the CONSORT (Consolidated Standards of Reporting Trials) harms extension and according to clinical trial design, and to examine re…
View article: Randomized phase III trial of metabolic imaging-guided dose escalation of radio-chemotherapy in patients with newly diagnosed glioblastoma (SPECTRO GLIO trial)
Randomized phase III trial of metabolic imaging-guided dose escalation of radio-chemotherapy in patients with newly diagnosed glioblastoma (SPECTRO GLIO trial) Open
Background Glioblastoma (GBM) systematically recurs after a standard 60 Gy radio-chemotherapy regimen. Since magnetic resonance spectroscopic imaging (MRSI) has been shown to predict the site of relapse, we analyzed the effect of MRSI-guid…
View article: Efficacy and Safety of Eculizumab in Pediatric Patients Affected by Shiga Toxin–Related Hemolytic and Uremic Syndrome: A Randomized, Placebo-Controlled Trial
Efficacy and Safety of Eculizumab in Pediatric Patients Affected by Shiga Toxin–Related Hemolytic and Uremic Syndrome: A Randomized, Placebo-Controlled Trial Open
Significance Statement Shiga toxin–related hemolytic uremic syndrome (STEC-HUS) is a serious condition, characterized by multiorgan thrombotic microangiopathy, mainly affecting children. Renal involvement is severe, with approximately half…
View article: Hypofractionated Stereotactic Re-irradiation and Anti-PDL1 Durvalumab Combination in Recurrent Glioblastoma: STERIMGLI Phase I Results
Hypofractionated Stereotactic Re-irradiation and Anti-PDL1 Durvalumab Combination in Recurrent Glioblastoma: STERIMGLI Phase I Results Open
Background Hypofractionated stereotactic radiotherapy (hFSRT) is a salvage option for recurrent glioblastoma (GB) which may synergize anti-PDL1 treatment. This phase I study evaluated the safety and the recommended phase II dose of anti-PD…
Data from Combining Nivolumab and Ipilimumab with Infliximab or Certolizumab in Patients with Advanced Melanoma: First Results of a Phase Ib Clinical Trial Open
Purpose:TNF blockers can be used to manage gastrointestinal inflammatory side effects following nivolumab and/or ipilimumab treatment in patients with advanced melanoma. Our preclinical data showed that anti-TNF could promote the efficacy …
Supplementary Data from Combining Nivolumab and Ipilimumab with Infliximab or Certolizumab in Patients with Advanced Melanoma: First Results of a Phase Ib Clinical Trial Open
This file contains supplemental tables and figures and their legends.
Data from Combining Nivolumab and Ipilimumab with Infliximab or Certolizumab in Patients with Advanced Melanoma: First Results of a Phase Ib Clinical Trial Open
Purpose:TNF blockers can be used to manage gastrointestinal inflammatory side effects following nivolumab and/or ipilimumab treatment in patients with advanced melanoma. Our preclinical data showed that anti-TNF could promote the efficacy …
Supplementary Data from Combining Nivolumab and Ipilimumab with Infliximab or Certolizumab in Patients with Advanced Melanoma: First Results of a Phase Ib Clinical Trial Open
This file contains supplemental tables and figures and their legends.
View article: TNFR-1 and GDF-15 Are Associated With Plasma Neurofilament Light Chain and Progranulin Among Community-Dwelling Older Adults: A Secondary Analysis of the MAPT Study
TNFR-1 and GDF-15 Are Associated With Plasma Neurofilament Light Chain and Progranulin Among Community-Dwelling Older Adults: A Secondary Analysis of the MAPT Study Open
There is growing evidence that cognitive decline can be affected by both nutritional aspects and inflammation. Plasma neurodegenerative biomarkers stand out as minimally invasive useful measures to monitor the potential risk of cognitive d…
View article: Bortezomib and high-dose melphalan conditioning regimen in frontline multiple myeloma: an IFM randomized phase 3 study
Bortezomib and high-dose melphalan conditioning regimen in frontline multiple myeloma: an IFM randomized phase 3 study Open
High-dose melphalan (HDM) and transplantation are recommended for eligible patients with multiple myeloma. No other conditioning regimen has proven to be more effective and/or safer. We previously reported in a phase 2 study that bortezomi…
Multicentric phase II trial of TI‐CE high‐dose chemotherapy with therapeutic drug monitoring of carboplatin in patients with relapsed advanced germ cell tumors Open
Background High‐dose chemotherapy (HDCT) with TI‐CE regimen is a valid option for the treatment of relapsed advanced germ cell tumors (GCT). We report a phase II trial with therapeutic drug monitoring of carboplatin for optimizing area und…
Combining Nivolumab and Ipilimumab with Infliximab or Certolizumab in Patients with Advanced Melanoma: First Results of a Phase Ib Clinical Trial Open
Purpose: TNF blockers can be used to manage gastrointestinal inflammatory side effects following nivolumab and/or ipilimumab treatment in patients with advanced melanoma. Our preclinical data showed that anti-TNF could promote the efficacy…
Radiofrequency ablation for adenoma in patients with primary aldosteronism and hypertension: ADERADHTA, a pilot study Open
Objective: To evaluate the efficacy and the feasibility of radiofrequency ablation to treat aldosterone-producing adenomas. Methods: In an open prospective bicentric pilot study, patients with hypertension on ambulatory blood pressure meas…
Compliance of French academic clinical trials with the Clinical Trial Facilitation and Coordination Group recommendations on contraception and pregnancy testing requirements Open
Background/Aims The Clinical Trials Coordination and Facilitation Group has issued recommendations on contraception and pregnancy testing to help sponsors meet regulatory expectations and harmonize practices to limit embryofetal risks in c…
VOTRAGE study pazopanib in a population of “frail” elderly patients after geriatric assessment: A phase I study with geriatric criteria Open
Background: Efficacy and toxicity of targeted therapies don't seem to vary with age, but the impact of side effects in frail elderly patients (≥ 75 years-old) (EP) is a major concern for clinicians. Our study aims to explore an original me…
View article: P01.094 Hypofractionnated Stereotactic Radiation Therapy and Durvalumab combination in recurrent Glioblastoma (GBM): Results of the phase I part of the phase I/II STERIMGLI trial
P01.094 Hypofractionnated Stereotactic Radiation Therapy and Durvalumab combination in recurrent Glioblastoma (GBM): Results of the phase I part of the phase I/II STERIMGLI trial Open
Glioblastoma multiforme (GBM) is the most common and aggressive primary brain tumor. Survival data in GBM are correlated with systematic local relapse, whose management is not standardized. Several treatments can be discussed in recurrent …
Serious adverse drug events related to non‐investigational drugs in academic clinical trials: another source of safety data for risk assessment? Open
Aims Sponsors of clinical trials have to analyze serious adverse events (SAEs). Both sponsors and investigators determine the relationship between the investigational medicinal product, the investigational device or procedure and SAEs. SAE…