Idecabtagene vicleucel chimeric antigen receptor T-cell therapy for relapsed/refractory multiple myeloma with renal impairment
Surbhi Sidana, Lauren C. Peres, Hamza Hashmi, Hitomi Hosoya, Christopher J. Ferreri, Jack Khouri, Danai Dima, Shebli Atrash, Peter M. Voorhees, Gary Simmons, Douglas W. Sborov, Nilesh Kalariya, Vanna Hovanky, Sushma Bharadwaj, David B. Miklos, Charlotte Wagner, Mehmet H. Kocoglu, Gurbakhash Kaur, James A. Davis, Shonali Midha, Murali Janakiram, Ciara L. Freeman, Melissa Alsina, Frederick L. Locke, Rebecca Gonzalez, Yi Lin, Joseph P. McGuirk, Aimaz Afrough, Leyla Shune, Krina K. Patel, Doris K. Hansen
Abstract
We evaluated patients with relapsed multiple myeloma with renal impairment (RI) treated with standard of care idecabtagene vicleucel (ide-cel), as outcomes with chimeric antigen receptor (CAR) T-cell therapy are unknown in this population. RI was defined as creatinine clearance (CrCl) <50 mL/min. CrCl of <30 mL/min or dialysis dependence were defined as severe RI. The study cohort included 214 patients, 28 (13%) patients with RI, including 11 patients severe RI (dialysis, N=1). Patients with RI were older, more likely to be female and had higher likelihood of having Revised International Staging System stage 3 disease. Rates and severity of cytokine release syndrome (89% vs. 84%, grade ≥3: 7% vs. 2%) and immune effector cell-associated neurotoxicity syndrome (23% vs. 20%) were similar in patients with and without RI, respectively. Patients with RI had higher incidence of short-term grade ≥3 cytopenias, although cytopenias were similar by 3 months following CAR T-cell therapy. Renal function did not worsen after CAR T-cell therapy in patients with RI. Response rates (93% vs. 82%) and survival outcomes (median progression-free survival: 9 vs. 8 months; P=0.26) were comparable in patients with and without RI, respectively. Treatment with ide-cel is feasible in patients with RI, with a comparable safety and efficacy profile as patients without RI, with notable exception of higher short-term high-grade cytopenias.