Am J Hematol. 2026 Apr 2. doi: 10.1002/ajh.70312. Online ahead of print.
ABSTRACT
Renal impairment (RI), defined as estimated glomerular filtration rate less than 60 mL/min with or without the need for dialysis, is a frequent and severe complication in patients with relapsed/refractory multiple myeloma (RRMM), as it can affect patient prognosis, drug metabolism and treatment options. Although bispecific antibodies (BsAbs) have been approved in RRMM patients, their safety and efficacy in patients with RI remain insufficiently characterized, as most clinical trials excluded individuals with significant renal dysfunction. This systematic review was conducted in accordance with the PRISMA guidelines. PubMed, Scopus, and ScienceDirect were searched up to February 2, 2026, for clinical trials and retrospective real-world studies evaluating BsAbs in RRMM patients with reported data from patients with RI. Abstracts presented in major international scientific congresses over the preceding 3 years, including ASH, IMS, ASCO, EHA, EMN, were also systematically screened. A total of 11 eligible studies were identified, including 3 pivotal trials and 8 real-world cohorts, encompassing 1117 patients. ORR, PFS and OS were comparable between patients with and without RI. Safety profile, including incidence of cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity (ICANS), infections and hematologic toxicities were also comparable across renal subgroups. Only the incidence of thrombocytopenia was significantly increased in patients with RI. Overall, BsAbs demonstrate substantial efficacy and manageable safety in RRMM patients with renal dysfunction. Outcomes were similar to those of patients with preserved renal function. These findings support the use of BsAbs in this high-risk population both in clinical practice and in future clinical trials.
PMID:41927459 | DOI:10.1002/ajh.70312