Isatuximab in combination with lenalidomide and dexamethasone in patients with high-risk smoldering multiple myeloma: Updated safety run-in results from the randomized phase 3 ithaca study

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dc.contributor.authorMateos, Maria-Victoria
dc.contributor.authorRodriguez Otero, Paula
dc.contributor.authorKoh, Youngil
dc.contributor.authorMartinez-Lopez, Joaquin
dc.contributor.authorParmar, Gurdeep
dc.contributor.authorPrince, H. Miles
dc.contributor.authorQuach, Hang
dc.contributor.authorRibas, Paz
dc.contributor.authorHermansen, Emil
dc.contributor.authorHungria, Vania T. M.
dc.contributor.authorKalayoğlu Beşışık, Sevgi
dc.contributor.authorKim, Jin Seok
dc.contributor.authorLeleu, Xavier
dc.contributor.authorPeceliunas, Valdas
dc.contributor.authorSchjesvold, Fredrik
dc.contributor.authorSevindik, Ömür Gökmen
dc.contributor.authorLavrova, Tatiana
dc.contributor.authorDubin, Franck
dc.contributor.authorDevisme, Christine
dc.contributor.authorLepine, Lucie
dc.contributor.authorGhobrial, Irene
dc.date.accessioned2023-03-17T07:55:18Z
dc.date.available2023-03-17T07:55:18Z
dc.date.issued2022
dc.departmentİstanbul Medipol Üniversitesi, Tıp Fakültesi, Dahili Tıp Bilimleri Bölümü, İç Hastalıkları Ana Bilim Dalı
dc.description.abstractBackground: Results from a randomized, Phase 3 study by the Spanish Myeloma Group (PETHEMA/GEM) previously showed that treatment with lenalidomide plus dexamethasone (Rd) may delay progression to active disease in patients (pts) with high-risk smoldering multiple myeloma (SMM), compared with observation. To further improve outcomes, addition of the anti-CD38 antibody isatuximab (Isa) to lenalidomide and dexamethasone (Isa-Rd) for the treatment of pts with high-risk SMM is being evaluated in the ongoing, randomized, multi-center, Phase 3 ITHACA study (NCT04270409). Initial findings from the safety run-in analysis of this trial have shown a manageable safety profile and encouraging, preliminary anti-myeloma activity. We now report updated safety and efficacy results from the safety run-in part of ITHACA at a median follow-up of 19.4 months. Methods: Pts were included in the study if they had been diagnosed within 5 years with SMM (per the International Myeloma Working Group [IMWG] criteria) and had high-risk SMM according to the Mayo '20-2-20' and/or updated PETHEMA model criteria. Pts who had received prior anti-myeloma treatment were not eligible. Enrolled pts received Isa 10 mg/kg IV on day (D) 1, 8, 15, and 22 in cycle (C) 1, D1 and D15 C2-12, D1 C13-36; plus R D1-21 (25 mg C1-9; 10 mg C10-24) and d weekly (40 mg, 20 mg for ?75 yr-old pts C1-9; 20 mg C10-24). Cycle duration was 28 days. Safety evaluations included treatment-emergent AEs (TEAEs)/serious AEs and laboratory parameters, graded by NCI-CTCAE v5.0. Response was determined by IMWG criteria (2016). Mandatory imaging by MRI and/or low-dose whole-body CT/PET-CT, and assessments of minimal residual disease (MRD, by next-generation sequencing in pts with very good partial response [VGPR] or better), were performed at protocol-defined time points. The primary study objective for the safety run-in was to confirm the recommended dose of Isa in combination with Rd. Overall response rate (ORR) and MRD negativity rate at 10-5 sensitivity were included as secondary endpoints.
dc.description.sponsorshipSanofien_US
dc.identifier.citationMateos, M.-V., Rodriguez Otero, P., Koh, Y., Martinez-Lopez, J., Parmar, G., Prince, H. M. ... Ghobrial, I. (2022). Isatuximab in combination with lenalidomide and dexamethasone in patients with high-risk smoldering multiple myeloma: Updated safety run-in results from the randomized phase 3 ithaca study. American Society of Hematology içinde (7317-7319. ss.). https://dx.doi.org/10.1182/blood-2022-157302
dc.identifier.doi10.1182/blood-2022-157302
dc.identifier.endpage7319
dc.identifier.issn0006-4971
dc.identifier.issn1528-0020
dc.identifier.issueSupplement: 1
dc.identifier.startpage7317
dc.identifier.urihttps://dx.doi.org/10.1182/blood-2022-157302
dc.identifier.urihttps://hdl.handle.net/20.500.12511/10630
dc.identifier.volume140
dc.identifier.wos000893230300143en_US
dc.identifier.wosqualityQ1
dc.indekslendigikaynakWeb of Science
dc.institutionauthorSevindik, Ömür Gökmen
dc.language.isoen
dc.publisherAmerican Society of Hematology
dc.relation.ispartofBlooden_US
dc.relation.publicationcategoryKonferans Öğesi - Uluslararası - Kurum Öğretim Elemanı
dc.rightsinfo:eu-repo/semantics/openAccess
dc.subject3 Ithaca Study
dc.subjectHigh-Risk Smoldering Multiple Myeloma
dc.subjectDexamethasone
dc.subjectLenalidomide
dc.titleIsatuximab in combination with lenalidomide and dexamethasone in patients with high-risk smoldering multiple myeloma: Updated safety run-in results from the randomized phase 3 ithaca study
dc.typeConference Object

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