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Phase I trial of isatuximab monotherapy in the treatment of refractory multiple myeloma

dc.contributor.authorMartin, Thomas
dc.contributor.authorStrickland, Stephen
dc.contributor.authorGlenn, Martha
dc.contributor.authorCharpentier, Eric
dc.contributor.authorGuillemin, Helene
dc.contributor.authorHsu, Karl
dc.contributor.authorMikhael, Joseph
dc.identifier.citationMartin, T., Strickland, S., Glenn, M. et al. Phase I trial of isatuximab monotherapy in the treatment of refractory multiple myeloma. Blood Cancer J. 9, 41 (2019).
dc.description.abstractThis phase I dose-escalation/expansion study evaluated isatuximab (anti-CD38 monoclonal antibody) monotherapy in patients with relapsed/refractory multiple myeloma (RRMM). Patients progressing on or after standard therapy received intravenous isatuximab (weekly [QW] or every 2 weeks [Q2W]). The primary objective was to determine the maximum tolerated dose (MTD) of isatuximab. Overall, 84 patients received >= 1 dose of isatuximab. The MTD was not reached; no cumulative adverse reactions were noted. The most frequent adverse events were infusion reactions (IRs), occurring in 37/73 patients (51%) following introduction of mandatory prophylaxis. IRs were mostly grade 1/2, occurred predominantly during Cycle 1, and led to treatment discontinuation in two patients. CD38 receptor occupancy reached a plateau of 80% with isatuximab 20 mg/kg (highest dose tested) and was associated with clinical response. In patients receiving isatuximab >= 10 mg/kg, overall response rate (ORR) was 23.8% (15/63), including one complete response. In high-risk patients treated with isatuximab 10 mg/kg (QW or Q2W), ORR was 16.7% (3/18). Median (range) duration of response at doses >= 10 mg/kg was 25 (8-30) weeks among high-risk patients versus 36 (6-85) weeks for other patients. In conclusion, isatuximab demonstrated a manageable safety profile and clinical activity in patients with RRMM.en_US
dc.description.sponsorshipWe would like to thank investigators Michel Attal, Lionel Karlin, Robert Kaufmann, Philippe Moreau, John Morris, Enrique Ocio, Joshua Richter, and Jesus San Miguel for their valued contribution to the study. We also thank the following individuals from Sanofi for their respective contributions: Chrisie Ding and Diane Stash (trial management); Kathryn Corzo, Franck Dubin, and Corina Oprea (trial design and management); Anthony Hamlett (statistical analysis); and Dorothee Semiond (pharmacokinetic analysis). This study was funded by Sanofi. Editorial assistance was provided by Neil Harrison and Louise Wright of Adelphi Communications Ltd, funded by Sanofi.en_US
dc.publisherBlood Cancer Journalen_US
dc.rightsThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons license, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons license and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this license, visit
dc.titlePhase I trial of isatuximab monotherapy in the treatment of refractory multiple myelomaen_US

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