Based on the outcomes of the TOURMALINE-MM1 trial-a global, randomized, double-blind, placebo-controlled phase III clinical study-the use of an oral proteasome inhibitor has been approved in combination with lenalidomide and dexamethasone (Rd) for the treatment of relapsed/refractory multiple myeloma (MM). In this study, we enrolled 41 Japanese patients, who constituted the safety population. The overall incidence of adverse events (AEs) was similar in IRd and placebo-Rd groups. AEs including thrombocytopenia, skin disorders (rash), vomiting, nausea, and diarrhea occurred more frequently in the IRd group than in the placebo-Rd group. There were no cumulative toxicities, and most toxicities were usually manageable with close monitoring, supportive care, and dose modifications. Compared with the overall safety population, the safety profile of Japanese patients was consistent. Moreover, in Japanese patients, there were no on-study deaths and the incidence of serious AEs was less frequent.
Download full-text PDF |
Source |
|---|---|
| http://dx.doi.org/10.11406/rinketsu.59.2399 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Adjuvant Atezolizumab for Early Triple-Negative Breast Cancer: The ALEXANDRA/IMpassion030 Randomized Clinical Trial.
JAMA
January 2025
Institut Jules Bordet, l'Université Libre de Bruxelles and Hôpital Universitaire de Bruxelles, Brussels, Belgium.
Importance: Triple-negative breast cancer is an aggressive subtype with a high incidence in young patients, a high incidence in non-Hispanic Black women, and a high risk of progression to metastatic cancer, a devastating sequela with a 12- to 18-month life expectancy. Until recently, one strategy for treating early-stage triple-negative breast cancer was chemotherapy after surgery. However, it was not known whether the addition of immune therapy to postsurgery chemotherapy would be beneficial.
View Article and Find Full Text PDFFirst-line biologics as a treatment for ulcerative colitis: a multicenter randomized control study.
J Gastroenterol
January 2025
Department of Gastroenterology and Hepatology, Kyorin University School of Medicine, Mitaka, Japan.
Background: Despite the availability of several biologics for ulcerative colitis (UC), there remains a critical need to identify first-line treatment biologics. The superiority of infliximab (IFX) over vedolizumab (VED) and ustekinumab (UST) was evaluated as initial UC treatments in patients with biologic-naïve UC.
Methods: This multicenter, randomized control trial was conducted across 20 Japanese medical institutions.
Peripheral Neuropathy in Systemic Sclerosis with Proximal Nerve Involvement: Diagnostic Challenges and Response to Corticosteroid Therapy.
Mod Rheumatol Case Rep
January 2025
Department of Respiratory Medicine and Clinical Immunology, Osaka University Graduate School of Medicine, Osaka, Japan.
Peripheral neuropathy is a complication in systemic sclerosis that is occasionally encountered in clinical settings. The mechanisms underlying this condition remain unclear and treatment strategies have not yet been established, making management challenging. Here, we report a case of peripheral neuropathy associated with systemic sclerosis that was successfully treated with corticosteroid therapy despite the absence of conventional inflammatory findings on histopathology or blood tests.
View Article and Find Full Text PDFPrevalence and clinical impact of disseminated intravascular coagulation in acute aortic dissection: a nationwide cohort study.
Res Pract Thromb Haemost
January 2025
Department of Emergency and Critical Care Medicine, Osaka Medical and Pharmaceutical University, Osaka, Japan.
Background: Acute aortic dissection is a life-threatening cardiovascular emergency with high mortality rates. Disseminated intravascular coagulation (DIC) is a critical complication in patients with acute aortic dissection; however, its incidence and impact on outcomes remain inconclusive.
Objectives: This study aimed to evaluate DIC prevalence and prognosis in patients with aortic dissection.
Treatment patterns and clinical profile in progressive pulmonary fibrosis: a Japanese cross-sectional survey.
Front Med (Lausanne)
January 2025
Department of Respiratory Medicine, Faculty of Medicine, Kyorin University, Tokyo, Japan.
Background: There is a paucity of real-world data on patients with interstitial lung diseases (ILDs) that are progressive, other than idiopathic pulmonary fibrosis (IPF), including treatment patterns and attitudes toward treatment. This study aimed to investigate the diagnosis, clinical characteristics, treatment paradigm and current decision-making practices of IPF and progressive pulmonary fibrosis (PPF) in a Japanese real-world setting.
Methods: Data were drawn from the Adelphi Real World PPF-ILD Disease Specific Programme™, a cross-sectional survey with retrospective data collection of pulmonologists and rheumatologists in Japan from April to October 2022.
Want AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!