Safety and efficacy of daratumumab in dialysis-dependent renal failure secondary to multiple myeloma

Rocchi, Serena; Tacchetti, Paola; Pantani, Lucia; Mancuso, Katia; Zannetti, Beatrice Anna; Cavo, Michèle; Zamagni, Elena

doi:10.3324/haematol.2018.191122

Cited by 27 publications

(16 citation statements)

References 15 publications

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“…Recently, results from a phase II clinical trial with pomalidomide and dexamethasone in patients with RI have been reported, with a PFS of 2·4 months in the cohort of patients requiring dialysis (Dimopoulos et al , ). Daratumumab data in patients with end‐stage RI requiring dialysis are based only on isolated case reports (Rocchi et al , ) and, to the best of our knowledge, our study is the first one to analyse the safety and efficacy of single‐agent daratumumab in patients with end‐stage renal disease.…”

Section: Resultsmentioning

confidence: 99%

Single‐agent daratumumab in patients with relapsed and refractory multiple myeloma requiring dialysis: results of a Spanish retrospective, multicentre study

et al. 2019

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Between 20-40% of patients with multiple myeloma (MM) present with renal impairment (RI) at diagnosis (Korbet & Schwartz, 2006; Kastritis et al., 2007) and up to 10% of them require dialysis (Dimopoulos et al., 2010). Prognosis in these patients remains significantly worse when compared with patients with normal renal function (Haynes et al., 2010). Daratumumab is an anti-CD38 IgG kappa human monoclonal antibody that has demonstrated superior clinical benefit across lines of therapy, either as monotherapy or when combined with standard-of-care regimens for the treatment of patients with relapsed and refractory MM (RRMM) (Usmani et al., 2016; van de Donk et al., 2016). However, data of daratumumab in patients with RRMM and dialysis-dependant renal failure are lacking. We report the efficacy and safety results from a retrospective Spanish study of daratumumab in patients with RRMM and end-stage RI requiring dialysis. Methods M.J.C. performed the research and contributed to analyzing of data and paper writing. J.D.L.R. was involved in designing the study, analysis, interpretation and reporting of the data, and wrote/reviewed the paper. All authors performed the research and reviewed the draft manuscript and approved the final version for publication.

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Section: Resultsmentioning

confidence: 99%

Single‐agent daratumumab in patients with relapsed and refractory multiple myeloma requiring dialysis: results of a Spanish retrospective, multicentre study

et al. 2019

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“…A few, isolated case reports with single dialysis-dependent patients have been published. [37][38][39][40] Results from a retrospective, multicenter, open-label study designed to evaluate safety and efficacy of daratumumab in RRMM patients with end-stage RI requiring hemodialysis (n=15) reported a median PFS of 8.7 months, OS of 12.2 months, and ORR of 40%. 41 The most common grade 3-4 hematologic AEs included thrombocytopenia (n=5), anemia (n=4), and neutropenia (n=4).…”

Section: Discussionmentioning

confidence: 99%

Isatuximab plus carfilzomib and dexamethasone versus carfilzomib and dexamethasone in relapsed multiple myeloma patients with renal impairment: IKEMA subgroup analysis

et al. 2021

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“…The results of the ICARIA-MM subgroup analysis provide the first evidence of improvement in renal function with a CD38-targeted therapy in patients with RRMM. Data on the anti-CD38 agent daratumumab in RRMM patients with RI are currently limited to small uncontrolled studies or case reports with single patients [ 23 , 24 ]. Data on elotuzumab, a humanized monoclonal antibody that binds signaling lymphocyte activation molecule F7 (SLAMF7), are also lacking in patients with RRMM and RI [ 5 ].…”

Section: Discussionmentioning

confidence: 99%

Isatuximab plus pomalidomide and dexamethasone in relapsed/refractory multiple myeloma patients with renal impairment: ICARIA-MM subgroup analysis

et al. 2020

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The randomized, phase 3 ICARIA-MM study investigated isatuximab (Isa) with pomalidomide and dexamethasone (Pd) versus Pd in patients with relapsed/refractory multiple myeloma and ≥2 prior lines. This prespecified subgroup analysis examined efficacy in patients with renal impairment (RI; estimated glomerular filtration rate <60 mL/min/1.73 m²). Isa 10 mg/kg was given intravenously once weekly in cycle 1, and every 2 weeks in subsequent 28-day cycles. Patients received standard doses of Pd. Median progression-free survival (PFS) for patients with RI was 9.5 months with Isa-Pd (n = 55) and 3.7 months with Pd (n = 49; hazard ratio [HR] 0.50; 95% confidence interval [CI], 0.30-0.85). Without RI, median PFS was 12.7 months with Isa-Pd (n = 87) and 7.9 months with Pd (n = 96; HR 0.58; 95% CI, 0.38-0.88). The overall response rate (ORR) with and without RI was higher with Isa-Pd (56 and 68%) than Pd (25 and 43%). Complete renal response rates were 71.9% (23/32) with Isa-Pd and 38.1% (8/21) with Pd; these lasted ≥60 days in 31.3% (10/32) and 19.0% (4/21) of patients, respectively. Isa pharmacokinetics were comparable between the subgroups, suggesting no need for dose adjustment in patients with RI. In summary, the addition of Isa to Pd improved PFS, ORR and renal response rates.

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Safety and efficacy of daratumumab in dialysis-dependent renal failure secondary to multiple myeloma

Cited by 27 publications

References 15 publications

Single‐agent daratumumab in patients with relapsed and refractory multiple myeloma requiring dialysis: results of a Spanish retrospective, multicentre study

Single‐agent daratumumab in patients with relapsed and refractory multiple myeloma requiring dialysis: results of a Spanish retrospective, multicentre study

Isatuximab plus carfilzomib and dexamethasone versus carfilzomib and dexamethasone in relapsed multiple myeloma patients with renal impairment: IKEMA subgroup analysis

Isatuximab plus pomalidomide and dexamethasone in relapsed/refractory multiple myeloma patients with renal impairment: ICARIA-MM subgroup analysis

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