Results of the daratumumab monotherapy early access treatment protocol in patients from Brazil with relapsed or refractory multiple myeloma
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:...
| Main Authors: | , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Elsevier
2021-10-01
|
| Series: | Hematology, Transfusion and Cell Therapy |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2531137920301231 |
| _version_ | 1819025368308252672 |
|---|---|
| author | Edvan de Queiroz Crusoé Flávia Cristina Fernandes Pimenta Angelo Maiolino Nelson Siqueira de Castro Huiling Pei Damila Trufelli Mariana Fernandez Luciana Barreto Herriot |
| author_facet | Edvan de Queiroz Crusoé Flávia Cristina Fernandes Pimenta Angelo Maiolino Nelson Siqueira de Castro Huiling Pei Damila Trufelli Mariana Fernandez Luciana Barreto Herriot |
| author_sort | Edvan de Queiroz Crusoé |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-12-21T05:09:34Z |
| format | Article |
| id | doaj.art-1f1e7ed4750b4a32812d19e02ced92d7 |
| institution | Directory Open Access Journal |
| issn | 2531-1379 |
| language | English |
| last_indexed | 2024-12-21T05:09:34Z |
| publishDate | 2021-10-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Hematology, Transfusion and Cell Therapy |
| spelling | doaj.art-1f1e7ed4750b4a32812d19e02ced92d72022-12-21T19:15:05ZengElsevierHematology, Transfusion and Cell Therapy2531-13792021-10-01434417423Results of the daratumumab monotherapy early access treatment protocol in patients from Brazil with relapsed or refractory multiple myelomaEdvan de Queiroz Crusoé0Flávia Cristina Fernandes Pimenta1Angelo Maiolino2Nelson Siqueira de Castro3Huiling Pei4Damila Trufelli5Mariana Fernandez6Luciana Barreto Herriot7Hospital Universitário Professor Edgard Santos, Universidade Federal da Bahia (HUPES-UFBA), Salvador, BA, Brazil; Corresponding author at: Rua Augusto Viana, S/N Bairro Canela CEP: 40110-060 – Nucleo de Estudos Clínicos- NECBA 1º subsolo, Salvador, BA, Brazil.Hospital Napoleão Laureano, João Pessoa, PB, Brazil; Universidade Federal da Paraiba (UFPB), João Pessoa, PB, BrazilHospital Universitário Clementino Fraga Filho, Universidade Federal do Rio de Janeiro (UFRJ), Rio de Janeiro, RJ, BrazilFundação Pio XII, Hospital de Câncer de Barretos, Barretos, SP, BrazilJanssen Research & Development, LLC, Horsham, PA, USAJanssen-Cilag Farmacêutica Ltda, São Paulo, SP, BrazilJanssen-Cilag, Buenos Aires, ArgentinaInstituto Nacional de Câncer, José Alencar Gomes da Silva (INCA), Rio de Janeiro, RJ, BrazilIntroduction: 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.http://www.sciencedirect.com/science/article/pii/S2531137920301231DaratumumabMonoclonal antibodyMultiple myelomaEarly access protocolBrazil |
| spellingShingle | Edvan de Queiroz Crusoé Flávia Cristina Fernandes Pimenta Angelo Maiolino Nelson Siqueira de Castro Huiling Pei Damila Trufelli Mariana Fernandez Luciana Barreto Herriot Results of the daratumumab monotherapy early access treatment protocol in patients from Brazil with relapsed or refractory multiple myeloma Hematology, Transfusion and Cell Therapy Daratumumab Monoclonal antibody Multiple myeloma Early access protocol Brazil |
| title | Results of the daratumumab monotherapy early access treatment protocol in patients from Brazil with relapsed or refractory multiple myeloma |
| title_full | Results of the daratumumab monotherapy early access treatment protocol in patients from Brazil with relapsed or refractory multiple myeloma |
| title_fullStr | Results of the daratumumab monotherapy early access treatment protocol in patients from Brazil with relapsed or refractory multiple myeloma |
| title_full_unstemmed | Results of the daratumumab monotherapy early access treatment protocol in patients from Brazil with relapsed or refractory multiple myeloma |
| title_short | Results of the daratumumab monotherapy early access treatment protocol in patients from Brazil with relapsed or refractory multiple myeloma |
| title_sort | results of the daratumumab monotherapy early access treatment protocol in patients from brazil with relapsed or refractory multiple myeloma |
| topic | Daratumumab Monoclonal antibody Multiple myeloma Early access protocol Brazil |
| url | http://www.sciencedirect.com/science/article/pii/S2531137920301231 |
| work_keys_str_mv | AT edvandequeirozcrusoe resultsofthedaratumumabmonotherapyearlyaccesstreatmentprotocolinpatientsfrombrazilwithrelapsedorrefractorymultiplemyeloma AT flaviacristinafernandespimenta resultsofthedaratumumabmonotherapyearlyaccesstreatmentprotocolinpatientsfrombrazilwithrelapsedorrefractorymultiplemyeloma AT angelomaiolino resultsofthedaratumumabmonotherapyearlyaccesstreatmentprotocolinpatientsfrombrazilwithrelapsedorrefractorymultiplemyeloma AT nelsonsiqueiradecastro resultsofthedaratumumabmonotherapyearlyaccesstreatmentprotocolinpatientsfrombrazilwithrelapsedorrefractorymultiplemyeloma AT huilingpei resultsofthedaratumumabmonotherapyearlyaccesstreatmentprotocolinpatientsfrombrazilwithrelapsedorrefractorymultiplemyeloma AT damilatrufelli resultsofthedaratumumabmonotherapyearlyaccesstreatmentprotocolinpatientsfrombrazilwithrelapsedorrefractorymultiplemyeloma AT marianafernandez resultsofthedaratumumabmonotherapyearlyaccesstreatmentprotocolinpatientsfrombrazilwithrelapsedorrefractorymultiplemyeloma AT lucianabarretoherriot resultsofthedaratumumabmonotherapyearlyaccesstreatmentprotocolinpatientsfrombrazilwithrelapsedorrefractorymultiplemyeloma |