Abstract
Introduction:
Teclistamab gained approval for relapsed/refractory Multiple Myeloma (RRMM) in late 2022; however, clinical trials of its use had excluded patients with severe renal insufficiency, hence data for teclistamab in this population is currently lacking.
Methods:
A multicenter retrospective study was conducted using the TriNetX database network, a federated de-identified EMR network that included adult patients with a history of RRMM and received Teclistamab between July 1st, 2022, and July 1st, 2025. Renal failure (RF) was defined as patients with an estimated glomerular filtration rate (eGFR) of less than 30ml/min or dialysis dependence. Statistical analysis was performed on the TrinetX research platform. Baseline patient demographics and clinical features were collected. The cohort was divided into two comparison groups: patients with and without severe renal impairment. Subsequently, 1:1 propensity matching was done with 1:1 (greedy) nearest neighbour without replacement with a caliper of 0.1, and outcomes were calculated with teclistamab use as the index event.
Results:
1058 patients were included in the analysis, 159 in the renal failure group and 899 in the non-renal failure comparison group. 55% were male, the average age at index was 69.3 ± 10.3 years, and 65% were white. Compared to the non-renal failure group, the renal failure group had more extramedullary disease (7.5% vs 5.3%) and a worse mean ECOG PS (1.3 vs 0.9) at baseline. 55 patients in the renal failure group were on dialysis. 1:1 propensity matching was done for age, sex, race, cardiovascular disease, stroke, chronic lung disease, obesity, ECOG PS, etc, yielding 296 patients in the final analysis (148 in each group). The mean follow-up for the renal failure group was 294 days vs 314 days for the non-renal failure comparison group. The renal failure group had 43 deaths vs 42 in the comparison group [HR 1.062 (0.694-1.625), p=0.966], 1-year OS was 63% in the RF failure group vs 78% in the non-RF failure group p=0.285, any grade cytokine release syndrome (CRS) events occurred in 34 in the RF group vs 35 in the non-RF comparison group [OR 0.963 (0.562-1.651) p=0.891, immune effector cell-associated neurotoxicity syndrome (ICANS) events were 13 vs 25 (OR 0.474 (0.232-0.967) p=0.04). Grade 3 or worse CRS and ICANS combined were fewer than 10 events in each group. Within 30-days of treatment, neutropenia (ANC < 1000 cells/uL) was seen in 32 in the RF group vs 33 in the non-RF comparison group [OR 0.961 (0.554-1.667), p=0.883], thrombocytopenia (platelets < 50,000 cells/uL) was seen in 39 vs 34 [OR=1.2 (0.706-2.037), p=0.5] and anemia (Hb < 7.0 gm/dl) was seen in 39 vs 24 [OR=1.625 (1.031-2.56), p=0.033]
Conclusion:
Patients with severe renal failure have comparable outcomes and a comparable safety profile with teclistamab in RRMM; hence, renal impairment should not exclude this cohort from receiving teclistamab. Our study showed a higher 30-day rate of anemia in the renal failure group likely due to anemia of CKD. Rate of ICANS was noted to be higher in the non-renal failure group, this is contradictory to reports in literature and the etiology remains unclear.
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