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Infections in patients receiving daratumumab for newly diagnosed multiple myeloma: a pooled analysis of MAIA and ALCYONE
Bahlis, Nizar Facon, Thierry San-Miguel, Jesus Usmani, Saad Z. Dimopoulos, Meletios A. Moreau, Philippe Zweegman, Sonja Perrot, Aurore Manier, Salomon Chari, Ajai
Bahlis, Nizar
Facon, Thierry
San-Miguel, Jesus
Usmani, Saad Z.
Dimopoulos, Meletios A.
Moreau, Philippe
Zweegman, Sonja
Perrot, Aurore
Manier, Salomon
Chari, Ajai
Authors
Bahlis, Nizar
Facon, Thierry
San-Miguel, Jesus
Usmani, Saad Z.
Dimopoulos, Meletios A.
Moreau, Philippe
Zweegman, Sonja
Perrot, Aurore
Manier, Salomon
Chari, Ajai
Raje, Noopur
Orlowski, Robert Z.
GoldSchmidt, Hartmut
Basu, Supratik
Hullin, Cyrille
Weisel, Katja
Mohty, Mohamad
Leleu, Xavier
Plesner, Torben
Jakubowiak, Andrzej
Cook, Gordon
Quach, Hang
Venner, Christopher P.
Cavo, Michele
Ngo, Mai
Bolyard, Kasey
Carson, Robin
Borgsten, Fredrik
Mateos, Maria-Victoria
Kumar, Shaji K.
Facon, Thierry
San-Miguel, Jesus
Usmani, Saad Z.
Dimopoulos, Meletios A.
Moreau, Philippe
Zweegman, Sonja
Perrot, Aurore
Manier, Salomon
Chari, Ajai
Raje, Noopur
Orlowski, Robert Z.
GoldSchmidt, Hartmut
Basu, Supratik
Hullin, Cyrille
Weisel, Katja
Mohty, Mohamad
Leleu, Xavier
Plesner, Torben
Jakubowiak, Andrzej
Cook, Gordon
Quach, Hang
Venner, Christopher P.
Cavo, Michele
Ngo, Mai
Bolyard, Kasey
Carson, Robin
Borgsten, Fredrik
Mateos, Maria-Victoria
Kumar, Shaji K.
Editors
Other contributors
Epub Date
Issue Date
2026-12-31
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Abstract
Both the phase 3 MAIA and ALCYONE studies demonstrated significant survival benefit with the addition of daratumumab to standard-of-care lenalidomide and dexamethasone (D-Rd) or bortezomib, melphalan, and prednisone (D-VMP), respectively, versus Rd or VMP alone in transplant-ineligible newly diagnosed multiple myeloma (NDMM). Patients with NDMM are highly susceptible to infection; therefore, gaining a greater understanding of infection incidence may help to mitigate future risk. We conducted a pooled analysis of infection incidence, timing, and management strategies from MAIA and ALCYONE. The median (range) age of the pooled population was 72 (40-93) years. Incidence was higher with D-Rd/D-VMP versus Rd/VMP for grade 3/4 (36.9% vs 22.4%) and grade 5 (3.0% vs 1.5%) infections; however, exposure-adjusted incidence rates were generally comparable between groups. Any grade infections led to discontinuation of study treatment in approximately 2% of patients across treatment groups. Of the timing intervals explored, the highest incidence of grade 3/4 infection occurred within the first 6-month interval of study treatment initiation in both groups. Median time to first onset of grade 3/4 infections (per Kaplan-Meier estimates) was 83.3 months and not estimable in D-Rd/D-VMP and Rd/VMP groups, respectively. While rates of D-Rd/D-VMP treatment discontinuation due to infection remained low in MAIA and ALCYONE, clinicians should remain vigilant about infections throughout treatment and follow local guidelines and International Myeloma Working Group recommendations to minimize the risk of infection.
Citation
Bahlis, N. et al (in press) Infections in patients receiving daratumumab for newly diagnosed multiple myeloma: a pooled analysis of MAIA and ALCYONE, Blood Advances.
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Research Unit
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PubMed ID
PubMed Central ID
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Type
Journal article
Language
en
Description
© 2026 The Authors. Published by American Society of Hematology. This is an open access article available under a Creative Commons licence.
The published version can be accessed at the following link on the publisher’s website: [DOI/weblink]
Series/Report no.
ISSN
2473-9537