000095319 001__ 95319
000095319 005__ 20230622083316.0
000095319 0247_ $$2doi$$a10.1097/HS9.0000000000000380
000095319 0248_ $$2sideral$$a119061
000095319 037__ $$aART-2020-119061
000095319 041__ $$aeng
000095319 100__ $$aAlegre, A
000095319 245__ $$aResults of an Early Access Treatment Protocol of Daratumumab Monotherapy in Spanish Patients With Relapsed or Refractory Multiple Myeloma
000095319 260__ $$c2020
000095319 5060_ $$aAccess copy available to the general public$$fUnrestricted
000095319 5203_ $$aDaratumumab 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 treatmentemergent 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.
000095319 540__ $$9info:eu-repo/semantics/openAccess$$aby-nc-nd$$uhttp://creativecommons.org/licenses/by-nc-nd/3.0/es/
000095319 592__ $$a0.677$$b2020
000095319 593__ $$aHematology$$c2020$$dQ3
000095319 655_4 $$ainfo:eu-repo/semantics/article$$vinfo:eu-repo/semantics/publishedVersion
000095319 700__ $$ade la Rubia, J
000095319 700__ $$aBalari, AS
000095319 700__ $$aRodriguez, CE
000095319 700__ $$aSuarez, A
000095319 700__ $$aBlanchard, MJ
000095319 700__ $$aLleonart, JB
000095319 700__ $$aRodriguez-Otero, P
000095319 700__ $$aInsunza, A
000095319 700__ $$0(orcid)0000-0001-8515-3599$$aPalomera, L$$uUniversidad de Zaragoza
000095319 700__ $$aPenarrubia, MJ
000095319 700__ $$aRios-Tamayo, R
000095319 700__ $$aMontero, LFC
000095319 700__ $$aGonzalez, MS
000095319 700__ $$aPotamianou, A
000095319 700__ $$aCouturier, C
000095319 700__ $$aPei, HL
000095319 700__ $$aHevia, H
000095319 700__ $$aMilionis, I
000095319 700__ $$aGaudig, M
000095319 700__ $$aMateos, MV
000095319 7102_ $$11007$$2610$$aUniversidad de Zaragoza$$bDpto. Medicina, Psiqu. y Derm.$$cArea Medicina
000095319 773__ $$g4, 3 (2020), e380 1-8$$pHemaSphere$$tHemaSphere$$x2572-9241
000095319 8564_ $$s525258$$uhttps://zaguan.unizar.es/record/95319/files/texto_completo.pdf$$yVersión publicada
000095319 8564_ $$s61775$$uhttps://zaguan.unizar.es/record/95319/files/texto_completo.jpg?subformat=icon$$xicon$$yVersión publicada
000095319 909CO $$ooai:zaguan.unizar.es:95319$$particulos$$pdriver
000095319 951__ $$a2023-06-21-15:02:10
000095319 980__ $$aARTICLE