Scientific publications
Results of an Early Access Treatment Protocol of Daratumumab Monotherapy in Spanish Patients With Relapsed or Refractory Multiple Myeloma. Scientific Publication
Adrián Alegre (1), Javier de la Rubia (2), Anna Sureda Balari (3), Cristina Encinas Rodríguez (4), Alexia Suárez (5), María Jesús Blanchard (6), Joan Bargay Lleonard (7), Paula Rodríguez-Otero (8), Andrés Insunza (9), Luis Palomera (10), María Jesús Peñarrubia (11), Rafael Ríos-Tamayo (12), Luis Felipe Casado Montero (13), Marta Sonia González (14), Anna Potamianou (15), Catherine Couturier (16), Huiling Pei (17), Henar Hevia (18), Iordanis Milionis (19), Maren Gaudig (15), María-Victoria Mateos (20)
(1) Hospital Universitario de La Princesa, Madrid, Spain.
(2) Hospital Dr. Peset and School of Medicine and Dentistry, Catholic University of Valencia, Valencia, Spain.
(3) Institut Català d'Oncologia-Hospitalet, Barcelona, Spain.
(4) Hospital General Universitario Gregorio Marañón, Instituto de Investigacion Sanitaria Gregorio Marañón, Madrid, Spain.
(5) Hospital Universitario Gran Canaria Dr. Negrin, Las Palmas, Spain.
(6) Ramón y Cajal University Hospital, Madrid, Spain.
(7) Hospital Sont Llàtzer, Palma de Mallorca, Spain.
(8) Clínica Universidad de Navarra, CIMA, IDISNA, CIBERONC, Pamplona, Spain.
(9) Department of Hematology, Hospital Universitario Marqués de Valdecilla, Santander, Spain.
(10) Hospital Clínico Universitario Lozano Blesa, Instituto de Investigación de Aragón, Zaragoza, Spain.
(11) Hospital Clínico Universitario de Valladolid, Valladolid, Spain.
(12) University Hospital Virgen de las Nieves, Granada, Spain.
(13) Hospital Virgen de la Salud, Toledo, Spain.
(14) Hospital Clínico de Santiago, Santiago, Spain.
(15) Janssen-Cilag, Neuss, Germany.
(16) Janssen-Cilag, Issy les Moulineaux, France.
(17) Janssen Research & Development, Horsham, Pennsylvania, United States.
(18) Janssen-Cilag Medical Affairs, Madrid, Spain.
(19) EMEA Medical Affairs, Janssen-Cilag Pharmaceutical SACI, Athens, Greece.
(20) University Hospital of Salamanca/IBSAL, Salamanca, Spain.
Daratumumab is a human CD38-targeted monoclonal antibody approved as monotherapy for heavily pretreated relapsed and refractory multiple myeloma.
We report findings for the Spanish cohort of an open-label treatment protocol that provided early access to daratumumab monotherapy and collected safety and patient-reported outcomes data for patients with relapsed or refractory multiple myeloma.
At 15 centers across Spain, intravenous daratumumab (16 mg/kg) was administered to 73 patients who had ≥3 prior lines of therapy, including a proteasome inhibitor and an immunomodulatory drug, or who were double refractory to both.
The median duration of daratumumab treatment was 3.3 (range: 0.03-13.17) months, with a median number of 12 (range: 1-25) infusions. Grade 3/4 treatment-emergent adverse events were reported in 74% of patients and included lymphopenia (28.8%), thrombocytopenia (27.4%), neutropenia (21.9%), leukopenia (19.2%), and anemia (15.1%). Common (>5%) serious treatment-emergent adverse events included respiratory tract infection (9.6%), general physical health deterioration (6.8%), and back pain (5.5%). Infusion-related reactions occurred in 45% of patients.
The median change from baseline in all domains of the EQ-5D-5L and EORTC QLQ-C30 was mostly 0. A total of 18 (24.7%) patients achieved a partial response or better, with 10 (13.7%) patients achieving a very good partial response or better. Median progression-free survival was 3.98 months.
The results of this early access treatment protocol are consistent with previously reported trials of daratumumab monotherapy and confirm its safety and antitumoral efficacy in Spanish patients with heavily treated relapsed or refractory multiple myeloma.
European Clinical Trials Database number: 2015-002993-19.
CITATION Hemasphere . 2020 Jun 3;4(3):e380. doi: 10.1097/HS9.0000000000000380. eCollection 2020 Jun.
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