Brief report: Clinical experiences after emergency use of daratumumab monotherapy for relapsed or refractory multiple myeloma in real practice

Park, Sung‐Soo; Eom, Hyeon-Seok; Kim, Jin Seok; Koh, Youngil; Choi, Chul Won; Lee, Je‐Jung; Kım, Kihyun; Suh, Cheolwon; Lee, Jae Hoon; Min, Chang‐Ki

doi:10.1093/jjco/hyy177

Cited by 12 publications

(15 citation statements)

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“…No IRRs or AEs led to treatment discontinuation. These are similar to previously reported findings, 8,9,[11][12][13][14][15]17 supporting the favorable tolerability and safety profile of daratumumab monotherapy in patients with RRMM. The likelihood of grade !…”

Section: Discussionsupporting

confidence: 92%

“…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%

“…In a multicenter retrospective study of 16 Korean patients after 4 lines of therapy, daratumumab monotherapy was reported to be associated with a higher ORR of 56.3% (PR in 31.3%, VGPR in 0%, CR in 25.0%). 12 The median PFS was 2.7 months (28.9% at 6 months). 12 However, after a median of 10 months of treatment, the PFS was considerably short (2.7months).…”

Section: Discussionmentioning

confidence: 96%

“…12 The median PFS was 2.7 months (28.9% at 6 months). 12 However, after a median of 10 months of treatment, the PFS was considerably short (2.7months).…”

Section: Discussionmentioning

confidence: 96%

“…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%

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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: Discussionsupporting

confidence: 92%

Section: Introductionmentioning

confidence: 66%

Section: Discussionmentioning

confidence: 96%

“…12 The median PFS was 2.7 months (28.9% at 6 months). 12 However, after a median of 10 months of treatment, the PFS was considerably short (2.7months).…”

Section: Discussionmentioning

confidence: 96%