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

Cejalvo, María J; Legarda, Mario; Abella, Eugènia; Cabezudo, Maria-Elena; Encinas, Cristina; García-Feria, Ana; Gironella, Mercedes; Iñigo, Belén; Martín, Jesús; Ribas, Paz; Ruiz, María Pérez; González, Yolanda; Vicuña, Isabel; Ramirez, A. Léndinez; Fernández, Pascual; Rubia, Javier de la

doi:10.1111/bjh.16286

Cited by 21 publications

(27 citation statements)

References 16 publications

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“…3 A pooled analysis of these monotherapy studies showed an overall response rate (ORR) of 31.1%, median progression-free survival (PFS) of 4.0 months, median overall survival (OS) of 20.1 months, and a manageable toxicity profile for patients treated with daratumumab at 16 mg/kg. 10 The efficacy and favorable tolerability of daratumumab monotherapy has been consistently reported from recent real-world studies performed in countries such as the United States, Korea, Poland, Spain, Italy, Russia, the United Kingdom, Hungary, and Japan, with the ORR ranging from 23% to 56.3% [11][12][13][14][15][16][17] ( Table 1).…”

Section: Introductionmentioning

confidence: 66%

“…Salomon-Perzy nski et al 13 Cejalvo et al 14 Cook et al 15 Lovas et al 16 Iida et al 17 Present Study (Turkish Cohort)…”

Section: Characteristicmentioning

confidence: 87%

“…Hence, our findings indicate that daratumumab monotherapy is an effective and tolerable treatment option for RRMM in Turkish patients, similar to that consistently reported in recent real-world studies from other countries. [11][12][13][14][15][16][17] The findings from the US cohort of a multicenter, open-label, daratumumab EAP study of patients with RRMM and ! 3 previous therapy lines revealed an ORR of 23% (PR in 18%, VGPR in 5%, stringent CR in 0.6%).…”

Section: Discussionmentioning

confidence: 99%

“…13 The preliminary findings from a retrospective, multicenter, openlabel study of patients with end-stage renal failure and RRMM from Spain revealed an ORR and clinical benefit rate (SD or better) of 50% (2 VGPR, 2 PR, and 2 SD) after a median follow-up of 12 months. 14 The investigators considered daratumumab monotherapy to be an efficacious and safe therapeutic option for patients presenting with end-stage renal failure requiring dialysis. 14 The AE profile was similar to that reported for patients with normal or moderately impaired renal function.…”

Section: Discussionmentioning

confidence: 99%

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Early Access Program Results From Turkey and a Literature Review on Daratumumab Monotherapy Among Heavily Pretreated Patients With Relapsed/Refractory Myeloma

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Aydın

Göker

et al. 2020

Clinical Lymphoma Myeloma and Leukemia

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The present study investigated the efficacy and safety profile of daratumumab monotherapy in 42 patients with relapsed refractory multiple myeloma through a Turkish early access program. The current findings have confirmed the efficacy of daratumumab monotherapy in heavily pretreated patients with refractory multiple myeloma because of the deep and durable responses and favorable safety and tolerability profile. Background: In countries where frontline drug approval is limited to first-generation proteasome inhibitors or immunomodulatory drugs, relapses have been both more frequent and less durable. We investigated real world data on the efficacy and safety of daratumumab monotherapy among patients with relapsed refractory multiple myeloma (RRMM) from Turkey using a prospective early access program. Patients and Methods: A total of 42 patients with RRMM after a minimum of 3 previous lines of proteasome inhibitor/immunomodulatory drug-based treatments were included from 25 centers across Turkey. Daratumumab monotherapy was administered intravenously at a dose of 16 mg/kg weekly (cycles 1-2), on alternate weeks (cycles 3-6), and monthly thereafter. Results: The median daratumumab monotherapy duration was 5.5 months (range, 0.2-28.7 months). The overall response rate was 45.2%, including 14 (33.3%) partial responses, 4 (9.5%) very good partial responses, and 1 (2.4%) complete response. The

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Section: Introductionmentioning

confidence: 66%

“…Salomon-Perzy nski et al 13 Cejalvo et al 14 Cook et al 15 Lovas et al 16 Iida et al 17 Present Study (Turkish Cohort)…”

Section: Characteristicmentioning

confidence: 87%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

See 2 more Smart Citations

Early Access Program Results From Turkey and a Literature Review on Daratumumab Monotherapy Among Heavily Pretreated Patients With Relapsed/Refractory Myeloma

Beksaç

Aydın

Göker

et al. 2020

Clinical Lymphoma Myeloma and Leukemia

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“…Of note, daratumumab as single agent was effective and safely administered, without the need of dose reduction, in 15 RRMM patients with end-stage renal disease requiring dialysis [22].…”

Section: Article Highlightsmentioning

confidence: 98%

Monoclonal antibodies in relapsed/refractory myeloma: updated evidence from clinical trials, real-life studies, and meta-analyses

Musto

Rocca

2020

Expert Review of Hematology

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Introduction: In the last few years, monoclonal antibodies have rapidly modified the therapeutic strategies for treating patients with multiple myeloma. Areas covered: In this review, the most recent literature data regarding indications for which monoclonal antibodies are currently or will be shortly approved as salvage therapies in relapsed/refractory myeloma are discussed. In particular, updated results until March 22, 2020 of antibodies directed against CD38 (daratumumab and isatuximab), SLAMF7 (elotuzumab), BCMA (GSK2857916/belantamab mafodotin), and PD-1/PD-1 L axis (nivolumab and pembrolizumab) will be analyzed in detail. Expert opinion: Monoclonal antibodies represent a new, very effective approach that will open novel and dynamic treatment scenarios for myeloma patients in the coming years. Optimal positioning and selection of different antibodies that are or will be soon available, appropriate combinations and careful evaluation of possible new toxicities should be considered in the future management of these patients.

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Clinically‐suspected cast nephropathy: A retrospective, national, real‐world study

et al. 2020

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Presentation with severe acute kidney injury due to cast nephropathy (CN) is a medical emergency in multiple myeloma (MM), with high risk of dialysis-dependent renal failure and death. Accrual of patients with CN into interventional studies is difficult, while phase III trials exclude patients with severe renal insufficiency. Real-world data are warranted. We assessed 2252 patients from the population-based Danish Multiple Myeloma Registry (DMMR) who were diagnosed between 2013 and 2017. We identified 204 patients with clinically-suspected CN, defined as serum creatinine concentration >177 μmol/L and serum free light chain (sFLC) concentration >1000 mg/L at the time of diagnosis. The median age was 72 years. Thirty-one percent of patients presented with dialysis-dependent renal failure. Kidney biopsies were performed in 19% of patients and showed CN in 74% of cases. Despite prompt initiation of bortezomib-based therapy in 94% of patients, 33% of patients died in the first year after diagnosis. Compared with the rest of the patients in the DMMR with symptomatic MM, patients with clinicallysuspected CN had worse overall survival (OS) irrespective of transplant eligibility. Achievement of renal recovery was associated with deep reductions of involved sFLC. Achievement of very good partial response or better in the first line of therapy and/or deep reduction of involved sFLC at 3 months after initiation of therapy were associated with superior OS. In conclusion, MM patients presenting with clinically-suspected CN have an alarmingly high one-year mortality when treated with current standards of care. Early and deep hematologic response is crucial for survival. 1 | INTRODUCTION Renal failure, defined by serum creatinine higher than 177 μmol/L, occurs in approximately 20%-30% of patients with multiple myeloma (MM) at the time of diagnosis. 1-4 Severe renal impairment requiring hemodialysis occurs in 3%-9% of all patients with newly-diagnosed MM, and unless renal function is recovered, it leads to considerable mortality during the first months after diagnosis. 1,2,5-10 Myeloma cast nephropathy (CN) is the most common form of monoclonal immunoglobulin-mediated kidney disease. 11,12 It results from the interaction of excessive amounts of monoclonal light chains with

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

Cited by 21 publications

References 16 publications

Early Access Program Results From Turkey and a Literature Review on Daratumumab Monotherapy Among Heavily Pretreated Patients With Relapsed/Refractory Myeloma

Early Access Program Results From Turkey and a Literature Review on Daratumumab Monotherapy Among Heavily Pretreated Patients With Relapsed/Refractory Myeloma

Monoclonal antibodies in relapsed/refractory myeloma: updated evidence from clinical trials, real-life studies, and meta-analyses

Clinically‐suspected cast nephropathy: A retrospective, national, real‐world study

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