Teclistamab for patients with heavily pretreated relapsed/refractory multiple myeloma and renal impairment

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...

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Main Authors: Danai Dima, Aimaz Afrough, Utkarsh Goel, Ariel F. Grajales-Cruz, Jack Khouri, Kelley Julian, Oren Pasvolsky, Rahul Banerjee, Beatrice Razzo, Christopher J. Ferreri, Mariola A. Vazquez-Martinez, James A. Davis, Aishwarya Sannareddy, Omar Castaneda, Shahzad Raza, Andrew J. Portuguese, Mahmoud R. Gaballa, Masooma S. Rana, Alex Lieberman-Cribbin, Shaun DeJarnette, Rebecca Gonzalez, Anna Chen, Megan M. Herr, Lekha Mikkilineni, Hitomi Hosoya, Evguenia Ouchveridze, Gurbakhash Kaur, Adriana Rossi, Leyla Shune, Faiz Anwer, Yi Lin, Shambavi Richard, Douglas W. Sborov, Rachid C. Baz, Alfred L. Garfall, Hans C. Lee, Larry D. Anderson, Jr., Andrew J. Cowan, Krina K. Patel, Peter M. Voorhees, Surbhi Sidana, Doris K. Hansen, Shebli Atrash, Sandra P. Susanibar-Adaniya
Format: Article
Language:English
Published: Elsevier 2025-07-01
Series:Blood Advances
Online Access:http://www.sciencedirect.com/science/article/pii/S2473952925002113
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author Danai Dima
Aimaz Afrough
Utkarsh Goel
Ariel F. Grajales-Cruz
Jack Khouri
Kelley Julian
Oren Pasvolsky
Rahul Banerjee
Beatrice Razzo
Christopher J. Ferreri
Mariola A. Vazquez-Martinez
James A. Davis
Aishwarya Sannareddy
Omar Castaneda
Shahzad Raza
Andrew J. Portuguese
Mahmoud R. Gaballa
Masooma S. Rana
Alex Lieberman-Cribbin
Shaun DeJarnette
Rebecca Gonzalez
Anna Chen
Megan M. Herr
Lekha Mikkilineni
Hitomi Hosoya
Evguenia Ouchveridze
Gurbakhash Kaur
Adriana Rossi
Leyla Shune
Faiz Anwer
Yi Lin
Shambavi Richard
Douglas W. Sborov
Rachid C. Baz
Alfred L. Garfall
Hans C. Lee
Larry D. Anderson, Jr.
Andrew J. Cowan
Krina K. Patel
Peter M. Voorhees
Surbhi Sidana
Doris K. Hansen
Shebli Atrash
Sandra P. Susanibar-Adaniya
author_facet Danai Dima
Aimaz Afrough
Utkarsh Goel
Ariel F. Grajales-Cruz
Jack Khouri
Kelley Julian
Oren Pasvolsky
Rahul Banerjee
Beatrice Razzo
Christopher J. Ferreri
Mariola A. Vazquez-Martinez
James A. Davis
Aishwarya Sannareddy
Omar Castaneda
Shahzad Raza
Andrew J. Portuguese
Mahmoud R. Gaballa
Masooma S. Rana
Alex Lieberman-Cribbin
Shaun DeJarnette
Rebecca Gonzalez
Anna Chen
Megan M. Herr
Lekha Mikkilineni
Hitomi Hosoya
Evguenia Ouchveridze
Gurbakhash Kaur
Adriana Rossi
Leyla Shune
Faiz Anwer
Yi Lin
Shambavi Richard
Douglas W. Sborov
Rachid C. Baz
Alfred L. Garfall
Hans C. Lee
Larry D. Anderson, Jr.
Andrew J. Cowan
Krina K. Patel
Peter M. Voorhees
Surbhi Sidana
Doris K. Hansen
Shebli Atrash
Sandra P. Susanibar-Adaniya
author_sort Danai Dima
collection DOAJ
description 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) <40 mL/min. CrCl <30 mL/min or dialysis dependence was 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 = .002) and have a higher median number of previous lines of therapy (7 vs 6; P = .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 most patients with RI outside of the context of disease progression. Overall response rate (52% vs 56%; P = .61) and survival outcomes (median progression-free survival, 4.6 vs 6.5 months; P = .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.
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spelling doaj-art-a0332191219941c5935d1f94fbed9dff2025-08-20T02:38:51ZengElsevierBlood Advances2473-95292025-07-019143408341710.1182/bloodadvances.2025016059Teclistamab for patients with heavily pretreated relapsed/refractory multiple myeloma and renal impairmentDanai Dima0Aimaz Afrough1Utkarsh Goel2Ariel F. Grajales-Cruz3Jack Khouri4Kelley Julian5Oren Pasvolsky6Rahul Banerjee7Beatrice Razzo8Christopher J. Ferreri9Mariola A. Vazquez-Martinez10James A. Davis11Aishwarya Sannareddy12Omar Castaneda13Shahzad Raza14Andrew J. Portuguese15Mahmoud R. Gaballa16Masooma S. Rana17Alex Lieberman-Cribbin18Shaun DeJarnette19Rebecca Gonzalez20Anna Chen21Megan M. Herr22Lekha Mikkilineni23Hitomi Hosoya24Evguenia Ouchveridze25Gurbakhash Kaur26Adriana Rossi27Leyla Shune28Faiz Anwer29Yi Lin30Shambavi Richard31Douglas W. Sborov32Rachid C. Baz33Alfred L. Garfall34Hans C. Lee35Larry D. Anderson, Jr.36Andrew J. Cowan37Krina K. Patel38Peter M. Voorhees39Surbhi Sidana40Doris K. Hansen41Shebli Atrash42Sandra P. Susanibar-Adaniya43Division of Hematology-Oncology, Fred Hutch Cancer Center, University of Washington, Seattle, WA; Department of Hematology-Oncology, Cleveland Clinic Taussig Cancer Center, Cleveland, OH; Correspondence: Danai Dima, Fred Hutchinson Cancer Center, 1100 Fairview Ave N, Seattle, WA 98109;Myeloma, Waldenstrom’s, and Amyloidosis Program, Simmons Comprehensive Cancer Center, UT Southwestern Medical Center, Dallas, TXDivision of Hematology-Oncology, Fred Hutch Cancer Center, University of Washington, Seattle, WADepartment of Blood and Marrow Transplantation and Cellular Immunotherapy, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FLDivision of Hematology-Oncology, Fred Hutch Cancer Center, University of Washington, Seattle, WADivision of Hematology and Hematologic Malignancies, Huntsman Cancer Institute, The University of Utah, Salt Lake City, UTDepartment of Lymphoma/Myeloma, MD Anderson Cancer Center, Houston, TXDivision of Hematology-Oncology, Fred Hutch Cancer Center, University of Washington, Seattle, WADepartment of Hematology-Oncology, University of Pennsylvania, Philadelphia, PADepartment of Hematologic Oncology and Blood Disorders, Atrium Health Levine Cancer Institute, Wake Forest University School of Medicine, Charlotte, NCDepartment of Blood and Marrow Transplantation and Cellular Immunotherapy, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FLDepartment of Pharmacy, University of South Carolina, Charleston, SCMyeloma, Waldenstrom’s, and Amyloidosis Program, Simmons Comprehensive Cancer Center, UT Southwestern Medical Center, Dallas, TXDepartment of Blood and Marrow Transplantation and Cellular Immunotherapy, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FLDepartment of Hematology-Oncology, Cleveland Clinic Taussig Cancer Center, Cleveland, OHDivision of Hematology-Oncology, Fred Hutch Cancer Center, University of Washington, Seattle, WADepartment of Lymphoma/Myeloma, MD Anderson Cancer Center, Houston, TXDivision of Bone Marrow Transplantation and Cellular Therapy, Stanford University School of Medicine, Stanford, CADivision of Hematology-Oncology, Icahn School of Medicine at Mount Sinai, New York, NYDepartment of Hematology-Oncology, University of Kansas Medical Center, Kasnas City, KSDepartment of Blood and Marrow Transplantation and Cellular Immunotherapy, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FLDepartment of Hematology-Oncology, University of Pennsylvania, Philadelphia, PADepartment of Medicine, Transplant and Cellular Therapy Program, Roswell Park Comprehensive Cancer Center, Buffalo, NYDivision of Bone Marrow Transplantation and Cellular Therapy, Stanford University School of Medicine, Stanford, CADivision of Bone Marrow Transplantation and Cellular Therapy, Stanford University School of Medicine, Stanford, CADepartment of Hematology-Oncology, University of Kansas Medical Center, Kasnas City, KSMyeloma, Waldenstrom’s, and Amyloidosis Program, Simmons Comprehensive Cancer Center, UT Southwestern Medical Center, Dallas, TXDivision of Hematology-Oncology, Icahn School of Medicine at Mount Sinai, New York, NYDepartment of Hematology-Oncology, University of Kansas Medical Center, Kasnas City, KSDepartment of Hematology-Oncology, Cleveland Clinic Taussig Cancer Center, Cleveland, OHDivision of Hematology, Mayo Clinic, Rochester, MNDivision of Hematology-Oncology, Icahn School of Medicine at Mount Sinai, New York, NYDivision of Hematology and Hematologic Malignancies, Huntsman Cancer Institute, The University of Utah, Salt Lake City, UTDepartment of Blood and Marrow Transplantation and Cellular Immunotherapy, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FLDepartment of Hematology-Oncology, University of Pennsylvania, Philadelphia, PADepartment of Lymphoma/Myeloma, MD Anderson Cancer Center, Houston, TXMyeloma, Waldenstrom’s, and Amyloidosis Program, Simmons Comprehensive Cancer Center, UT Southwestern Medical Center, Dallas, TXDivision of Hematology-Oncology, Fred Hutch Cancer Center, University of Washington, Seattle, WADepartment of Lymphoma/Myeloma, MD Anderson Cancer Center, Houston, TXDepartment of Hematologic Oncology and Blood Disorders, Atrium Health Levine Cancer Institute, Wake Forest University School of Medicine, Charlotte, NCDivision of Bone Marrow Transplantation and Cellular Therapy, Stanford University School of Medicine, Stanford, CADepartment of Blood and Marrow Transplantation and Cellular Immunotherapy, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FLDepartment of Hematologic Oncology and Blood Disorders, Atrium Health Levine Cancer Institute, Wake Forest University School of Medicine, Charlotte, NCDepartment of Hematology-Oncology, University of Pennsylvania, Philadelphia, PAAbstract: 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) <40 mL/min. CrCl <30 mL/min or dialysis dependence was 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 = .002) and have a higher median number of previous lines of therapy (7 vs 6; P = .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 most patients with RI outside of the context of disease progression. Overall response rate (52% vs 56%; P = .61) and survival outcomes (median progression-free survival, 4.6 vs 6.5 months; P = .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.http://www.sciencedirect.com/science/article/pii/S2473952925002113
spellingShingle Danai Dima
Aimaz Afrough
Utkarsh Goel
Ariel F. Grajales-Cruz
Jack Khouri
Kelley Julian
Oren Pasvolsky
Rahul Banerjee
Beatrice Razzo
Christopher J. Ferreri
Mariola A. Vazquez-Martinez
James A. Davis
Aishwarya Sannareddy
Omar Castaneda
Shahzad Raza
Andrew J. Portuguese
Mahmoud R. Gaballa
Masooma S. Rana
Alex Lieberman-Cribbin
Shaun DeJarnette
Rebecca Gonzalez
Anna Chen
Megan M. Herr
Lekha Mikkilineni
Hitomi Hosoya
Evguenia Ouchveridze
Gurbakhash Kaur
Adriana Rossi
Leyla Shune
Faiz Anwer
Yi Lin
Shambavi Richard
Douglas W. Sborov
Rachid C. Baz
Alfred L. Garfall
Hans C. Lee
Larry D. Anderson, Jr.
Andrew J. Cowan
Krina K. Patel
Peter M. Voorhees
Surbhi Sidana
Doris K. Hansen
Shebli Atrash
Sandra P. Susanibar-Adaniya
Teclistamab for patients with heavily pretreated relapsed/refractory multiple myeloma and renal impairment
Blood Advances
title Teclistamab for patients with heavily pretreated relapsed/refractory multiple myeloma and renal impairment
title_full Teclistamab for patients with heavily pretreated relapsed/refractory multiple myeloma and renal impairment
title_fullStr Teclistamab for patients with heavily pretreated relapsed/refractory multiple myeloma and renal impairment
title_full_unstemmed Teclistamab for patients with heavily pretreated relapsed/refractory multiple myeloma and renal impairment
title_short Teclistamab for patients with heavily pretreated relapsed/refractory multiple myeloma and renal impairment
title_sort teclistamab for patients with heavily pretreated relapsed refractory multiple myeloma and renal impairment
url http://www.sciencedirect.com/science/article/pii/S2473952925002113
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