مؤتمر
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
| العنوان: | 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 |
|---|---|
| المؤلفون: | Mateos, Maria-Victoria, Rodriguez Otero, Paula, Koh, Youngil, Martinez-Lopez, Joaquin, Parmar, Gurdeep, Prince, H. Miles, Quach, Hang, Ribas, Paz, Hermansen, Emil, Hungria, Vania T. M., Kalayoğlu Beşışık, Sevgi, Kim, Jin Seok, Leleu, Xavier, Peceliunas, Valdas, Schjesvold, Fredrik, Sevindik, Ömür Gökmen, Lavrova, Tatiana, Dubin, Franck, Devisme, Christine, Lepine, Lucie, Ghobrial, Irene |
| بيانات النشر: | American Society of Hematology |
| سنة النشر: | 2022 |
| المجموعة: | İstanbul Medipol University Institutional Repository (DSpace@Medipol) |
| مصطلحات موضوعية: | 3 Ithaca Study, High-Risk Smoldering Multiple Myeloma, Dexamethasone, Lenalidomide |
| الوصف: | Background: 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 ... |
| نوع الوثيقة: | conference object |
| وصف الملف: | application/pdf |
| اللغة: | English |
| تدمد: | 0006-4971 1528-0020 |
| العلاقة: | Blood; Konferans Öğesi - Uluslararası - Kurum Öğretim Elemanı; Mateos, 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-2022-157302Test; https://dx.doi.org/10.1182/blood-2022-157302Test; https://hdl.handle.net/20.500.12511/10630Test; 140; Supplement: 1; 7317; 7319; Q1; 000893230300143 |
| DOI: | 10.1182/blood-2022-157302 |
| الإتاحة: | https://doi.org/20.500.12511/10630Test https://doi.org/10.1182/blood-2022-157302Test https://hdl.handle.net/20.500.12511/10630Test |
| حقوق: | info:eu-repo/semantics/openAccess |
| رقم الانضمام: | edsbas.E0CCCC3C |
| قاعدة البيانات: | BASE |
Full Text Finder | تدمد: | 00064971 15280020 |
|---|---|
| DOI: | 10.1182/blood-2022-157302 |