The most common nonhematologic TEAEs of any grade were diarrhea (56%), fatigue (56%), hypocalcemia (50%), and constipation (50%) . The vast majority of those were grade 1/2. The most common grade 3/4 nonhematologic TEAEs were pneumonia (25%), hypophosphatemia (13%), and rash (13%).
Eleven patients (69%) had at least 1 serious AE, including 3 (19%) related to daratumumab. There were no treatment discontinuations due to AEs and no deaths due to serious AEs. Thirteen patients (81%) developed infections, the most common being upper respiratory tract infection in 6, pneumonia in 4, bronchitis in 2, and otitis and viral gastroenteritis in 2 each.
Daratumumab infusion reactions were reported in 4 (25%) patients, none of whom had grade 3/4 infusion reactions.
“I am happy to report that the randomized phase II portion of the trial, which includes 222 patients, finished enrollment in April of this year, and we should have data on that in 2019,” Voorhees said.
Voorhees PM, Rodriguez C, Reeves B, et al. Efficacy and updated safety analysis of a safety run-in cohort from Griffin, a phase 2 randomized study of daratumumab (dara), bortezomib (V), lenalidomide (R), and dexamethasone (D; dara‐vrd) vs. vrd in patients (pts) with newly diagnosed (ND) multiple myeloma (MM) eligible for high‐dose therapy (HDT) and autologous stem cell transplantation (ASCT). Presented at: 2018 ASH Annual Meeting; Dec. 1-4, 2018; San Diego. Abstract 151.
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