Results of an Early Access Treatment Protocol of Daratumumab Monotherapy in Spanish Patients With Relapsed or Refractory Multiple Myeloma

Abstract

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

Daratumumab Monotherapy for Relapsed or Refractory Multiple Myeloma: Results of an Early Access Treatment Protocol in Europe and Russia

“…The most common grade 3/4 TEAEs reported by patients were hematologic, a finding consistent with results reported in previous clinical trials and in the U.S. and Spanish cohorts of this EAP [15,23,24,29]. IRRs were reported in 45.1% of patients and mostly occurred during the first infusion; the most common IRRs were respiratory, also similar to findings reported previously [15,23,24,29].…”

“…and Spanish cohorts of this EAP study, respectively [23,24,29]. The rates of CR or better and VGPR or better were also similar to those reported in the SIRIUS study [29].…”

“…MMY3010 is a multicenter, open-label, early access treatment protocol (EAP) designed to provide early access to daratumumab monotherapy and collect additional safety and patient-reported outcomes (PROs) data for patients with heavily pre-treated RRMM. Results from U.S. and Spanish cohorts of MMY3010 were consistent with those from previously reported clinical trials of daratumumab monotherapy and confirmed the safety profile of daratumumab in patients with heavily pretreated RRMM [23,24]. Here, we present results from a pooled analysis of patients with RRMM enrolled in MMY3010 from the UK, Spain, Italy, and Russia.…”

“…However, comparisons between the current study and other clinical studies are limited by differences in eligibility criteria and study design. In the previously reported Spanish cohort of this EAP, rates of grade 3/4 TEAEs and any-grade SAEs were similarly higher than in the U.S. cohort; however, patients from the European and Russian cohort had a longer exposure to daratumumab and an increased number of daratumumab infusions compared to U.S. patients [ 23 , 24 ]. The most common grade 3/4 TEAEs reported by patients were hematologic, a finding consistent with results reported in previous clinical trials and in the U.S. and Spanish cohorts of this EAP [ 15 , 23 , 24 , 29 ].…”

“…No new safety concerns were identified, and HRQoL was maintained. Of note, results from patients in the Spanish cohort included in this pooled analysis were previously published in a separate report [ 24 ]. The data collected from this European and Russian cohort expand on and complement the previously reported results from the U.S. ( N = 348) and Spanish ( N = 73) cohorts of this EAP [ 23 , 24 ].…”