Early Access Treatment Protocol of Daratumumab in European and Russian Patients With Resistant Myeloma
Posted: Friday, March 26, 2021
The anti-CD38 monoclonal antibody daratumumab was approved in the United States and Europe as monotherapy for heavily pretreated patients with relapsed or refractory multiple myeloma; however, according to Maria-Victoria Mateos, MD, PhD, of the University Hospital of Salamanca, Spain, and colleagues, not all patients have access to commercially available daratumumab. The results of the MMY3010 early access treatment protocol in Europe and Russia were published in Oncology and Therapy.
“No new safety concerns were identified, and health-related quality of life was maintained during daratumumab treatment,” the investigators remarked. “The results from this study confirm the favorable safety profile of daratumumab monotherapy in patients from Europe and Russia with heavily pretreated relapsed or refractory multiple myeloma.”
A total of 293 patients from the United Kingdom, Spain, Italy, and Russia were administered 16 mg/kg of intravenous daratumumab for a median duration of 4.2 months. Patient-reported health-related quality-of-life outcomes were evaluated using the European Quality-of-Life-Five-Dimensions Questionnaire, the European Organisation for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire, and the EORTC Multiple Myeloma Module.
In this population, the overall response rate was 33.1%. The median duration of progression-free survival was 4.6 months. Treatment-emergent adverse events of grades 3 and 4 were reported in 60.1% of patients; thrombocytopenia (18.8%), anemia (11.9%), and neutropenia (11.6%) occurred most frequently. Pneumonia (4.4%) and pyrexia (4.1%) were among the most commonly reported serious adverse events. A total of 45.1% of patients experienced infusion-related reactions. According to the investigators, the median change from baseline in all domains of patient-reported outcome instruments was generally 0 or close to 0.
Disclosure: For full disclosures of the study authors, visit link.springer.com.
