Haematologica (Sep 2023)

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 Ferreri,
  • Jack Khouri,
  • Danai Dima,
  • Shebli Atrash,
  • Peter Voorhees,
  • Gary Simmons,
  • Douglas W. Sborov,
  • Nilesh Kalariya,
  • Vanna Hovanky,
  • Sushma Bharadwaj,
  • David Miklos,
  • Charlotte Wagner,
  • Mehmet H. Kocoglu,
  • Gurbakhash Kaur,
  • James A. Davis,
  • Shonali Midha,
  • Murali Janakiram,
  • Ciara Freeman,
  • Melissa Alsina,
  • Frederick Locke,
  • Rebecca Gonzalez,
  • Yi Lin,
  • Joseph McGuirk,
  • Aimaz Afrough,
  • Leyla Shune,
  • Krina K. Patel,
  • Doris K. Hansen

DOI
https://doi.org/10.3324/haematol.2023.283940
Journal volume & issue
Vol. 109, no. 3

Abstract

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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.