Real-World Data on the Efficacy of Daratumumab in Patients with Relapsed/Refractory Multiple Myeloma and Amplification 1q
Year: 2025
Type: article
Study design: Observational Study
Abstract: Background: Treatment of multiple myeloma has advanced tremendously with the approval of anti-CD38 antibodies. Their efficacy is impressive but still controversial in the 1q amplification subgroup (amp1q). This retrospective study aims to provide real-world data. Methods: This trial is analyzing 74 patients with relapsed/refractory multiple myeloma treated with CD38Abs at the Medical University of Innsbruck (2016–2023). High-risk (HR) cytogenetics according to R-ISS (t(4;14), t(14;16), t(14;20), del(17p)), the presence of amp(1q21), the frequency of two HR markers (double hit), and the high-risk criteria agreed at IMS 2024 (HR-IMS24) were considered. Results: The median age of the 74 patients (62.1% male) was 62 years, with a median follow-up of six years. Most patients received third-line therapy (37.8%). R-ISS HR was documented in 39.2% of patients, double hit in 13.5% of patients, and HR-IMS24 in 32.4% of patients, while amp1q was detected in 35.1% of patients. The median OS was 66 months (35–89), and the median PFS was 17 months (6.5–26.9). While neither R-ISS HR nor isolated amp1q had an impact on progression-free survival (e.g., amp1q 7.03: 1.95–22.44; p = 0.347), the occurrence of a double-hit pattern significantly impaired PFS and OS (6.2: 1.4–16.4 months; p = 0.044; OS, 42.8: 25.9–74.6 months; p = 0.035). Patients fulfilling the HR-IMS24 criteria (32.4%, 24 patients) also exhibited an impaired PFS and OS (7: 2.7–18.1 months, p = 0.023; 40.12: 21.1–74.5 months, p = 0.01). Conclusions: This retrospective study highlights the durable effect of daratumumab on cytogenetic abnormalities, particularly amp1q. However, patients who meet the criteria for double-hit myeloma or the high-risk IMS2024 criteria remain a difficult-to-treat patient population who require early access to new treatment approaches.
Source: Cancers
Authors: Magdalena Benda, Patrick Reimann, Elena Bletzacher, Axel Muendlein, Benda Bernhard, Bernd Hartmann, Minh Huynh, Klaus Gasser, Niklas Zojer, Theresia Lang, Georg Göbel, Jan-Paul Bohn, Stefan Schmidt, Eberhard Gunsilius, David Nachbaur, Emina Jukic, Maurus Locher, Ella Willenbacher, Wolfgang Willenbacher, Thomas Winder, Normann Steiner
Institutions: Landeskrankenhaus Feldkirch, Private University in the Principality of Liechtenstein, Innsbruck Medical University, Universität Innsbruck, Vorarlberg Institute for Vascular Investigation and Treatment, University Hospital Innsbruck, University of Bern, University Hospital of Bern, University of Zurich
Language: English
Subfield: Hematology
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $3,499
OpenAlex ID: W4409301235