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Results of the daratumumab monotherapy early access treatment protocol in patients from Brazil with relapsed or refractory multiple myeloma
Crusoé, Edvan de Queiroz; Pimenta, Flávia Cristina Fernandes; Maiolino, Angelo; Castro, Nelson Siqueira de; Pei, Huiling; Trufelli, Damila; Fernandez, Mariana; Herriot, Luciana Barreto.
  • Crusoé, Edvan de Queiroz; Universidade Federal da Bahia - UFBA. Hospital Universitário Professor Edgard Santos. Salvador. BR
  • Pimenta, Flávia Cristina Fernandes; Hospital Napoleão Laureano. João Pessoa. BR
  • Maiolino, Angelo; Universidade Federal do Rio de Janeiro - UFRJ. Hospital Universitário Clementino Fraga Filho. Rio de Janeiro. BR
  • Castro, Nelson Siqueira de; Hospital de Câncer de Barretos. Fundação Pio XII. Barretos. BR
  • Pei, Huiling; Janssen Research & Development. Horsham. US
  • Trufelli, Damila; Janssen-Cilag Farmacêutica Ltda. São Paulo. BR
  • Fernandez, Mariana; Janssen-Cilag. Buenos Aires. AR
  • Herriot, Luciana Barreto; Instituto Nacional de Câncer - INCA. Rio de Janeiro. BR
Hematol., Transfus. Cell Ther. (Impr.) ; 43(4): 417-423, Oct.-Dec. 2021. tab, graf
Article in English | LILACS | ID: biblio-1350799
ABSTRACT
ABSTRACT

Introduction:

Daratumumab is a CD38-targeting monoclonal antibody with established efficacy and safety in patients with relapsed or refractory multiple myeloma (RRMM). We report results of an early access protocol (EAP) of daratumumab monotherapy for RRMM in a cohort of Brazilian patients.

Methods:

Patients with RRMM and ≥3 prior lines of therapy, including a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD), or who were double refractory to both a PI and IMiD received daratumumab, 16 mg/kg, intravenously weekly for 8 weeks, biweekly for 16 weeks, and every 4 weeks thereafter until disease progression, unacceptable toxicity, loss of clinical benefit, or study conclusion or if daratumumab became available with reimbursement.

Results:

Forty-nine patients received ≥1 dose of daratumumab. The median (range) duration of treatment was 6.4 (0.3-11.8) months, with a median (range) of 8 (1-13) treatment cycles. Grade 3/4 treatment-emergent adverse events (TEAEs) were reported in 38.8% of patients, most frequently neutropenia and pneumonia (10.2% each). Seven (14.3%) patients discontinued treatment due to TEAEs; 3 patients discontinued due to daratumumab-related TEAEs. Serious TEAEs occurred in 38.8% of patients. Infusion-related reactions were reported in 25 (51.0%) patients, were primarily grade 1/2, and the majority (23 patients) occurred during the first infusion. Twenty (40.8%) patients achieved a partial response or better; median progression-free survival was 8.25 (95% confidence interval, 5.55-17.54) months.

Conclusion:

In this EAP, daratumumab monotherapy in Brazilian patients showed a safety and efficacy profile consistent with clinical studies of daratumumab monotherapy in patients with heavily pretreated RRMM. ClinicalTrials.gov identifier NCT02477891.
Subject(s)


Full text: Available Index: LILACS (Americas) Main subject: Multiple Myeloma Type of study: Practice guideline Limits: Adolescent / Adult / Aged / Aged80 / Female / Humans / Male Country/Region as subject: South America / Brazil Language: English Journal: Hematol., Transfus. Cell Ther. (Impr.) Journal subject: Hematologia / TransfusÆo de Sangue Year: 2021 Type: Article Affiliation country: Argentina / Brazil / United States Institution/Affiliation country: Hospital Napoleão Laureano/BR / Hospital de Câncer de Barretos/BR / Instituto Nacional de Câncer - INCA/BR / Janssen Research & Development/US / Janssen-Cilag Farmacêutica Ltda/BR / Janssen-Cilag/AR / Universidade Federal da Bahia - UFBA/BR / Universidade Federal do Rio de Janeiro - UFRJ/BR

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Full text: Available Index: LILACS (Americas) Main subject: Multiple Myeloma Type of study: Practice guideline Limits: Adolescent / Adult / Aged / Aged80 / Female / Humans / Male Country/Region as subject: South America / Brazil Language: English Journal: Hematol., Transfus. Cell Ther. (Impr.) Journal subject: Hematologia / TransfusÆo de Sangue Year: 2021 Type: Article Affiliation country: Argentina / Brazil / United States Institution/Affiliation country: Hospital Napoleão Laureano/BR / Hospital de Câncer de Barretos/BR / Instituto Nacional de Câncer - INCA/BR / Janssen Research & Development/US / Janssen-Cilag Farmacêutica Ltda/BR / Janssen-Cilag/AR / Universidade Federal da Bahia - UFBA/BR / Universidade Federal do Rio de Janeiro - UFRJ/BR