Danai Dima, Aimaz Afrough, Utkarsh Goel, Ariel Grajales-Cruz, Jack Khouri, Kelley Julian, Oren Pasvolsky, Rahul Banerjee, Beatrice Razzo, Christopher J Ferreri, Mariola Alejandra Vazquez Martinez, James A Davis, Aishwarya Sannareddy, Omar Castaneda Puglianini, Shahzad Raza, Andrew J Portuguese, Mahmoud R Gaballa, Masooma Rana, Alex Lieberman-Cribbin, Shaun DeJarnette, Rebecca Gonzalez, Anna Chen, Megan M Herr, Lakha Mikkilineni, Hitomi Hosoya, Evguenia Ouchveridze, Gurbakhash Kaur, Adriana C Rossi, Leyla Shune, Faiz Anwer, Yi Lin, Shambavi Richard, Douglas W Sborov, Rachid C Baz, Alfred Garfall, Hans C Lee, Larry D Anderson, Andrew J Cowan, Krina K Patel, Peter M Voorhees, Surbhi Sidana, Doris K Hansen, Shebli Atrash, Sandra P Susanibar-Adaniya
{"title":"Teclistamab for Patients with Heavily Pretreated Relapsed/Refractory Multiple Myeloma and Renal Impairment.","authors":"Danai Dima, Aimaz Afrough, Utkarsh Goel, Ariel Grajales-Cruz, Jack Khouri, Kelley Julian, Oren Pasvolsky, Rahul Banerjee, Beatrice Razzo, Christopher J Ferreri, Mariola Alejandra Vazquez Martinez, James A Davis, Aishwarya Sannareddy, Omar Castaneda Puglianini, Shahzad Raza, Andrew J Portuguese, Mahmoud R Gaballa, Masooma Rana, Alex Lieberman-Cribbin, Shaun DeJarnette, Rebecca Gonzalez, Anna Chen, Megan M Herr, Lakha Mikkilineni, Hitomi Hosoya, Evguenia Ouchveridze, Gurbakhash Kaur, Adriana C Rossi, Leyla Shune, Faiz Anwer, Yi Lin, Shambavi Richard, Douglas W Sborov, Rachid C Baz, Alfred Garfall, Hans C Lee, Larry D Anderson, Andrew J Cowan, Krina K Patel, Peter M Voorhees, Surbhi Sidana, Doris K Hansen, Shebli Atrash, Sandra P Susanibar-Adaniya","doi":"10.1182/bloodadvances.2025016059","DOIUrl":null,"url":null,"abstract":"<p><p>Outcomes of bispecific antibodies in patients with renal impairment (RI) are not well-characterized given the exclusion of these patients from clinical trials. Herein, we evaluated patients with relapsed/refractory multiple myeloma and RI treated with standard-of-care teclistamab. RI was defined as creatinine clearance (CrCl) <40mL/min. CrCl <30mL/min or dialysis dependence were defined as severe RI. Of the 384 included patients, 81 (21%) had RI, including 45 (18%) with severe RI, and 18 (5%) on dialysis. Patients with RI were more likely to be older (median age 71 vs. 67 years, p=0.002), and have a higher median number of prior lines of therapy (7 vs. 6, p=0.04). Rates and severity of cytokine release syndrome (51% vs. 59%, grade ≥3: 1.2% vs. 1%) and immune effector cell-associated neurotoxicity syndrome (16% vs. 13%; grade ≥3: 2.5% vs 2.6%) were similar in patients with and without RI, respectively. Patients with RI had higher baseline and day-30 post-teclistamab grade ≥3 anemia and grade ≥3 thrombocytopenia. Renal function did not worsen after teclistamab initiation in patients with RI outside of the context of disease progression. Overall response rate (52% vs. 56%, p=0.61) and survival outcomes (median progression-free survival: 4.6 vs. 6.5 months; p=0.62) were comparable in patients with and without RI, respectively, after a median follow-up of 9.9 months. No differences in overall survival or non-relapse mortality were noted. Our findings suggest that treatment with teclistamab is feasible in patients with RI including those on dialysis, with a similar safety and efficacy profile to patients without RI.</p>","PeriodicalId":9228,"journal":{"name":"Blood advances","volume":" ","pages":""},"PeriodicalIF":7.4000,"publicationDate":"2025-04-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Blood advances","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1182/bloodadvances.2025016059","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"HEMATOLOGY","Score":null,"Total":0}
引用次数: 0
Abstract
Outcomes of bispecific antibodies in patients with renal impairment (RI) are not well-characterized given the exclusion of these patients from clinical trials. Herein, we evaluated patients with relapsed/refractory multiple myeloma and RI treated with standard-of-care teclistamab. RI was defined as creatinine clearance (CrCl) <40mL/min. CrCl <30mL/min or dialysis dependence were defined as severe RI. Of the 384 included patients, 81 (21%) had RI, including 45 (18%) with severe RI, and 18 (5%) on dialysis. Patients with RI were more likely to be older (median age 71 vs. 67 years, p=0.002), and have a higher median number of prior lines of therapy (7 vs. 6, p=0.04). Rates and severity of cytokine release syndrome (51% vs. 59%, grade ≥3: 1.2% vs. 1%) and immune effector cell-associated neurotoxicity syndrome (16% vs. 13%; grade ≥3: 2.5% vs 2.6%) were similar in patients with and without RI, respectively. Patients with RI had higher baseline and day-30 post-teclistamab grade ≥3 anemia and grade ≥3 thrombocytopenia. Renal function did not worsen after teclistamab initiation in patients with RI outside of the context of disease progression. Overall response rate (52% vs. 56%, p=0.61) and survival outcomes (median progression-free survival: 4.6 vs. 6.5 months; p=0.62) were comparable in patients with and without RI, respectively, after a median follow-up of 9.9 months. No differences in overall survival or non-relapse mortality were noted. Our findings suggest that treatment with teclistamab is feasible in patients with RI including those on dialysis, with a similar safety and efficacy profile to patients without RI.
期刊介绍:
Blood Advances, a semimonthly medical journal published by the American Society of Hematology, marks the first addition to the Blood family in 70 years. This peer-reviewed, online-only, open-access journal was launched under the leadership of founding editor-in-chief Robert Negrin, MD, from Stanford University Medical Center in Stanford, CA, with its inaugural issue released on November 29, 2016.
Blood Advances serves as an international platform for original articles detailing basic laboratory, translational, and clinical investigations in hematology. The journal comprehensively covers all aspects of hematology, including disorders of leukocytes (both benign and malignant), erythrocytes, platelets, hemostatic mechanisms, vascular biology, immunology, and hematologic oncology. Each article undergoes a rigorous peer-review process, with selection based on the originality of the findings, the high quality of the work presented, and the clarity of the presentation.