Single-agent daratumumab in very advanced relapsed and refractory multiple myeloma patients: a real-life single-center retrospective study

Jullien, Maxime; Trudel, Sabrina; Tessoulin, Benoît; Mahé, Béatrice; Dubruille, Viviane; Blin, Nicolas; Gastinne, Thomas; Bonnet, Antoine; Lok, Anne; Lebourgeois, Amandine; Péterlin, Pierre; Garnier, Alice; Chevalier, Patrice; Guillaume, Thierry; Thomare, P.; Gouill, Steven Le; Moreau, Philippe; Touzeau, Cyrille

doi:10.1007/s00277-019-03655-5

Cited by 31 publications

(22 citation statements)

References 14 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…As for the drug's safety profile, therapy was well tolerated with less than one third of cohort with grade 3-4 hematological (anemia, platelet reduction) and around one fifth having nonhematological AEs, that were in line with the results of GEN501 and SIRIUS (8,9). Regarding the infectious AEs, compared to other real-life studies, the incidence of grade 3-4 events was lower (31)(32)(33)(34)(35). We can hypothesize that the use of antiviral and antibiotic prophylaxis, together with on demand G-CSF supportive therapy could have been of aid in reducing the incidence of infectious complications, similar to our previous real-life experience with Poma-Dex (44) and KRd regimen (40).…”

Section: Discussionsupporting

confidence: 60%

“…On the other hand, real-life studies on daratumumab evaluated the efficacy and tolerability in overall population, thus elaborating the drug's every-day use. Even though different population studies had significant variation in patient size, double-refractory status and follow-up (31)(32)(33)(34)(35), ORR and PFS described in the majority of real-life studies were at least equal, if not superior compared to clinical trials ( Table 5, Supplementary Materials) (30).…”

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

Daratumumab as Single Agent in Relapsed/Refractory Myeloma Patients: A Retrospective Real-Life Survey

et al. 2021

View full text Add to dashboard Cite

BackgroundThe anti-CD38 monoclonal antibody daratumumab is approved as a single agent for the treatment of patients with relapsed/refractory multiple myeloma (RRMM) who received at least three prior lines of therapy, including proteasome inhibitor and immunomodulatory agent. A retrospective multicentric study was designed to evaluate feasibility, tolerability, and efficacy of daratumumab in monotherapy in RRMM.MethodsThis study included 44 consecutive RRMM patients that underwent daratumumab monotherapy after a median number of four prior therapies (range 2–9). Patients were treated in seven Sicilian centers, as part of Sicilian Myeloma Network and three Calabrian centers outside of controlled clinical trials from August 2016 through July 2020.ResultsThe regimen was well tolerated with few grade 3–4 haematological and rare non-haematological adverse events, such as pneumonia. Definitive discontinuation was due to disease progression in 25 (57%) patients. Since three patients did not complete at least one full cycle, a total of 41 patients was evaluated for response. Overall response rate was 37%, and the disease control rate (stable disease or better) was high (73%). The best achieved responses within 6 months were very good partial remission or better (27%), partial remission (10%), minimal response (14%) and stable disease (22%). After a median follow up of 7.8 months, median progression free survival (PFS) was 7.2 months and overall survival (OS) 7.8 months. Univariate analysis showed that patients with PR or better after 6 months of therapy had longer median PFS and OS (respectively 29.5 vs 3.6 months, p=0.0001 and 30.6 vs 3.9 months p=0.0001), confirmed by multivariate analysis. Furthermore, standard cytogenetic risk and biochemical relapse type had prolonged median PFS, but not OS (respectively unreached vs 2.6, p=0.03 and 23.9 vs 6.2, p=0.05) in both univariate and multivariate analysis. Additionally, univariate analysis showed that patients treated with carfilzomib-lenalidomide-dexamethasone prior to daratumumab had significantly shorter PFS compared to pomalidomide-dexamethasone (3.4 months vs 9.3 months, p=0.03), that multivariate analysis failed to confirm.ConclusionsOur findings indicate that daratumumab as single agent is safe and well-tolerated regimen in real-life, associated to prolonged PFS and OS in responding patients. No new safety signals were identified.

show abstract

Section: Discussionsupporting

confidence: 60%

Section: Discussionmentioning

confidence: 99%

Daratumumab as Single Agent in Relapsed/Refractory Myeloma Patients: A Retrospective Real-Life Survey

et al. 2021

View full text Add to dashboard Cite

show abstract

“…Modest efficacy of single-agent daratumumab was observed in a real-life, mono-center series of 41 RRMM patient refractory to the last treatment received and treated with daratumumab after receiving a median number of 4 prior therapies (including PI and IMIDs) [19]. Most of them presented with high-risk characteristics, extramedullary disease, or leukemic dissemination.…”

Section: Daratumumab As Single Agentmentioning

confidence: 99%

“…Fifteen patients after 1-3 prior lines (median 2) have been enrolled so far. After a median of 7 (1)(2)(3)(4)(5)(6)(7)(8)(9)(10)(11)(12)(13)(14)(15)(16)(17)(18)(19)(20) cycles, current ORR is 87%. Seven patients achieved VGPR and 6 patients PR.…”

Section: Elotuzumab In Combination With Pismentioning

confidence: 99%

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

Musto

Rocca

2020

Expert Review of Hematology

View full text Add to dashboard Cite

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.

show abstract

“…Перспективным в лечении ЭП у пациентов с ММ может стать применение даратумумаба, антитела против CD38, эффективность и безопасность которого подтверждены в клинических исследованиях у пациентов с рецидивирующей и рефрактерной ММ, в том числе с внекостными поражениями [38][39][40][41]. Другие антитела, такие как анти-CD38-антитело изатуксимаб и анти-SLAMF7 элотузумаб, также продемонстрировали значительную эффективность в терапии резистентной или рефрактерной ММ, в связи с чем можно ожидать их успешного применения и при ЭП [42,43].…”

Section: клинический случайunclassified

The late extramedullary relapse of the multiple myeloma with a predominant lesion of the duodenum and pancreas (clinical observation and mini-review)

Рукавицын¹,

Крюков²,

Троян³

et al. 2019

Onkogematologiâ

View full text Add to dashboard Cite

Приводится описание случая множественной миеломы. У пациента развилось экстрамедуллярное поражение с преимущественной локализацией в двенадцатиперстной кишке в виде массивной плазмоцитомы, склонной к кровоточивости, с поражением поджелудочной железы и лимфатических узлов. Пациент получил несколько линий терапии, включая ингибиторы протеасом и противоопухолевые иммуномодуляторы до появления экстрамедуллярных поражений. Экстрамедуллярный рецидив был выявлен при позитронно-эмиссионной томографии, совмещенной с компьютерной томографией (ПЭТ / КТ), задолго до появления явных клинических признаков, что подчеркивает целесообразность включения ПЭТ / КТ в диагностический алгоритм для данной категории пациентов. Повторная терапия с применением ранее используемых бортезомиба или леналидомида была малоэффективной, отмечались дальнейший рост плазмоцитомы в двенадцатиперстной кишке и появление внутрикишечного кровотечения, что привело к анемии тяжелой степени. Назначение карфилзомиба с помалидомидом и дексаметазоном позволило после 3 циклов лечения достигнуть полной ремиссии. В данном клиническом случае мы дополнительно применяли кларитромицин и метформин для улучшения противомиеломной активности леналидомида, помалидомида и карфилзомиба в рамках перепрофилирования назначений неопухолевых препаратов. В кратком обзоре литературы анализируются частота внекостных поражений, причины их появления, подходы к диагностике и терапии. Экстрамедуллярные поражения при множественной миеломе-опасное проявление клональной эволюции заболевания, при которых возможности терапии все еще ограничены. Представлена демонстрация успешного лечения с карфилзомибом, показывающая ценность новых методов терапии, а также потенциальные возможности воздействия на опухолевую клетку при перепрофилировании назначений препаратов.

show abstract

Single-agent daratumumab in very advanced relapsed and refractory multiple myeloma patients: a real-life single-center retrospective study

Cited by 31 publications

References 14 publications

Daratumumab as Single Agent in Relapsed/Refractory Myeloma Patients: A Retrospective Real-Life Survey

Daratumumab as Single Agent in Relapsed/Refractory Myeloma Patients: A Retrospective Real-Life Survey

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

The late extramedullary relapse of the multiple myeloma with a predominant lesion of the duodenum and pancreas (clinical observation and mini-review)

Contact Info

Product

Resources

About