PMID- 38519329 OWN - NLM STAT- Publisher LR - 20240322 IS - 2152-2669 (Electronic) IS - 2152-2669 (Linking) DP - 2024 Feb 12 TI - Recent Developments in Convenience of Administration of the Anti-CD38 Antibody Isatuximab: Subcutaneous Delivery and Fast Intravenous Infusion in Patients With Multiple Myeloma. LID - S2152-2650(24)00063-6 [pii] LID - 10.1016/j.clml.2024.02.004 [doi] AB - Isatuximab-based combinations are among the accepted standard-of-care regimens for early-line treatment of patients with relapsed/refractory multiple myeloma (RRMM), based on the results of the Phase 3 ICARIA-MM and IKEMA trials. Further study findings have shown benefit with Isa-based combinations in patients with newly diagnosed MM, as reported from the randomized GMMG-HD7 and CONCEPT trials. Isa is currently approved in various countries for intravenous (IV) administration in patients with RRMM. A more convenient route of administration, such as subcutaneous (SC) injection, and faster IV infusion may substantially increase convenience of treatment. In this review, we outline evidence emerging from clinical trials that shows increasing clinical applicability of Isa across the MM therapeutic spectrum. We then review recent study results demonstrating that new treatment modalities, either SC Isa administration via an on-body delivery system (OBDS) or fast, 30-minute, fixed-volume IV infusion, are safe and effective, and enhance convenience of treatment with Isa for MM patients and healthcare providers. In the recently reported Phase 1b study, the safety profile and efficacy of Isa administered SC plus pomalidomide-dexamethasone were comparable to those observed with Isa administered IV plus pomalidomide-dexamethasone in the control arm and in the ICARIA-MM trial. Analysis of patient-reported outcomes indicated patient confidence in SC Isa administration and satisfaction with treatment delivery by OBDS. These findings point to SC administration as the preferred route for future treatment with Isa-based combinations, as well as to the use of fast, 30-minute IV infusions in settings where SC administration of Isa might not be available. CI - Copyright (c) 2024 Elsevier Inc. All rights reserved. FAU - Quach, Hang AU - Quach H AD - Clinical Haematology Service, St Vincent's Hospital Melbourne, University of Melbourne, Vic, Australia. Electronic address: hang.quach@svha.org.au. FAU - Parmar, Gurdeep AU - Parmar G AD - Illawarra Cancer Care Centre, Wollongong, NSW, Australia. FAU - Mateos, Maria-Victoria AU - Mateos MV AD - University Hospital of Salamanca and Cancer Research Center (IBMCC-CSICUSAL), Salamanca, Spain. FAU - Ailawadhi, Sikander AU - Ailawadhi S AD - Division of Hematology/Oncology, Mayo Clinic Florida, Jacksonville, FL. FAU - Leleu, Xavier AU - Leleu X AD - Service d'Hematologie et Therapie Cellulaire, CHU and CIC Inserm 1402, Poitiers Cedex, France. LA - eng PT - Journal Article PT - Review DEP - 20240212 PL - United States TA - Clin Lymphoma Myeloma Leuk JT - Clinical lymphoma, myeloma & leukemia JID - 101525386 SB - IM OTO - NOTNLM OT - Infusion pump OT - Newly diagnosed multiple myeloma OT - OBDS OT - on-body delivery system, Relapsed/refractory multiple myeloma EDAT- 2024/03/23 05:42 MHDA- 2024/03/23 05:42 CRDT- 2024/03/22 23:03 PHST- 2024/01/05 00:00 [received] PHST- 2024/02/08 00:00 [accepted] PHST- 2024/03/23 05:42 [medline] PHST- 2024/03/23 05:42 [pubmed] PHST- 2024/03/22 23:03 [entrez] AID - S2152-2650(24)00063-6 [pii] AID - 10.1016/j.clml.2024.02.004 [doi] PST - aheadofprint SO - Clin Lymphoma Myeloma Leuk. 2024 Feb 12:S2152-2650(24)00063-6. doi: 10.1016/j.clml.2024.02.004.