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COLUMBA Trial: Subcutaneous Versus Intravenous Daratumumab Therapy for Resistant Myeloma

By: Joshua D. Madera, MS
Posted: Wednesday, February 8, 2023

According to the phase III noninferiority COLUMBA trial, the subcutaneous (SC) administration of the monoclonal antibody daratumumab is preferred over intravenous (IV) administration of the agent for the treatment of relapsed or refractory multiple myeloma, given its rapid administration time and decreased rate of infusion-related reactions. Both routes of administration had similar safety and efficacy profiles, but the reduced treatment burden imposed on patients through SC administration seem to support its preference, suggested Saad Z. Usmani, MD, of Memorial Sloan Kettering Cancer Center, New York, and colleagues. The team published its study results in Haematologica.

A total of 522 patients with relapsed or refractory multiple myeloma were recruited for the study. All patients were characterized based on their baseline body weight, number of previous therapies, and myeloma type. Patients were then randomly assigned to receive 1,800 mg of SC daratumumab (n = 263) or 16 mg/kg of IV daratumumab (n = 259). During the first two cycles of therapy, patients received weekly treatment. During cycles 3 through 6, patients were treated biweekly. Following cycle 6, patients received treatment once every 4 weeks until they experienced toxicity or disease progression.

The authors reported 43.7% and 39.8% overall response rates in the SC and IV groups, respectively. Patients in the SC and IV groups had a 5.6- and 6.1-month median progression-free survival, respectively. Moreover, the median overall survival was 28.2 months with SC daratumumab and 25.6 months with IV daratumumab. The risk of adverse events was similar between both treatment groups (50.8% with SC daratumumab vs. 52.7 with IV daratumumab) and included anemia (13.8% vs. 15.1%), thrombocytopenia (14.2% vs. 13.6%), and neutropenia (13.1% vs. 7.8%), respectively.

Disclosure: For full disclosures of the study authors, visit haematologica.org.


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