Clinical Lymphoma, Myeloma & Leukemia, Vol.22, Suppl.2 - October 2022

Abstracts Clinical Lymphoma, Myeloma & Leukemia October 2022 S404 lenalidomide containing regimens with benefits maintained through subsequent therapies and a manageable safety profile. Moreover, PFS analysis using FDA censoring rules showed consistent results with the IA. Our findings support Isa-Kd as a standard-of-care treatment for relapsed MM patients. Keywords: MM, IKEMA, isatuximab, multiple myeloma, progression-free survival, Phase III MM-067 The Role of Some Cytokines in Plasma Cell Neoplasms in Gomel Region Residents Zhanna Kozich PhD 1 , Victor Martinkov PhD 1 , Janna Pugacheva Dr 1 , Ludmila Karataeva Dr 1 , Dzmitry Blizin MD 1 , Natalya Klimkovich PhD 2 1 Republican Research Center for Radiation Medicine and Human Ecology, Gomel, Belarus. 2 Belarusian Medical Academy of Postgraduate Education, Minsk, Belarus Co n text: Plasma cell neoplasms (PCN) are monoclonal proliferations of plasma cells that produce a clonal paraprotein. Various cytokines are involved in the immune response and inflammatory processes in plasma cell neoplasms. Objecti v e: To determine the levels of selected cytokines in the blood serum of patients with plasma cell neoplasms and to study their role in progression. D esig n : The study was conducted from October 2018 to January 2022. Setti n g: Republican Research Center for Radiation Medicine and Human Ecology Gomel, Belarus Patie n ts: 210 PCN patients (median monoclonal gammopathy of undetermined significance (MGUS), n=90; multiple melanoma (MM), n=101; solitary plasmacytoma (SP), n=19). The median MGUS age was 61.0 (54.0 and 6 7 .0), MM-65.0 (58.0 and 7 0.0), SP-61.0 (54.0 and 68.0). I n ter v e n tio n s: Cytokines (IL1, IL2, IL6, IL8 and TNF-  ) were determined. Mai n Outco m es a n dMeasures: Studied cytokines are associated with the process activity in PCN. Results: The levels of IL2 (p=0.001), IL6 (p=0.006) and TNF-  (p=0.006) with the progression of MM in comparison with MGUS and SP. An excess of IL8 levels was found in patients with MM with bone and kidney damage, in MGUS patients with progression (p = 0.014). An excess of the IL6 level (p=0.00001) was revealed in MM patients at the stages of ISSII and ISSIII and with high levels of LDH (p=0.0088), anemic syndrome (p=0.0064) and hypercalcemia (p=0.021). We have revealed a significant excess of the levels of IL1 (p=0.0036), IL2 (p=0.069) and TNF-  (p=0.043) in MM patients of a high- risk group (  /  <0.1 and >10), in comparison with the group with the absence of this criterion. A correlation was revealed in MM patients by levels of IL1 (p=0.02), IL6 (p=0.00001), IL8 (p=0.02) and TNF-  (p=0.004), IL6 (p=0.0004), IL8 (p=0.015) and TNF-  (0.006), in SP patients by IL6 level (p=0.05). Co n clusio n s: The progression of diseases is characterized by an increase in the levels of various cytokines, depending on the signs of organ damage: in MM it was reflected by IL2, IL6, and TNF-  , in MGUS by IL1, and IL6, and in SP by IL1. When detecting lytic lesions and kidney damage, we have revealed a correlation with the level of IL8 and TNF-  . Keywords: MM, multiple myeloma, monoclonal gammopathy of undetermined significance, solitary plasmacytoma, cytokines, progression MM-071 Subcutaneous (SC) Isatuximab (Isa) Administration by an On-Body Delivery System (OBDS) in Combination With Pomalidomide-Dexamethasone (Pd) in Relapsed/Refractory Multiple Myeloma (RRMM) Patients: Interim Phase 1b Study Results Hang Quach MD 1 , Gurdeep Parmar MD 2 , Enrique M. Ocio MD 3 , H. Miles Prince MD 4 , Albert Oriol MD 5 , Nobuhiro Tsukada MD 6 , Kazutaka Sunami MD 7 , Pierre Bories MD 8 , Chatchada Karanes MD 9 , Sumit Madan MD 10 , Dorothee Semiond PhD 11 , Marlene Inchauspe MS 12 , Sandrine Macé PhD 13 , Florence Suzan MD 13 , Philippe Moreau MD 14 1 Clinical Haematology Service, St Vincent’s Hospital, University of Melbourne, Melbourne, Vic, Australia. 2 Illawarra Cancer Care Centre, Wollongong, NSW, Australia. 3 Hospital Universitario Marqués de Valdecilla (IDIVAL), Universidad de Cantabria, Santander, Spain. 4 Molecular Oncology and Cancer Immunology, Epworth Healthcare and University of Melbourne, Melbourne, Vic, Australia. 5 Institut Català d’Oncologia and Institut Josep Carreras, Hospital Germans Trias i Pujol, Barcelona, Spain. 6 Department of Hematology, Japanese Red Cross Medical Center, Tokyo, Japan. 7 National Hospital Organization Okayama Medical Center, Okayama, Japan. 8 Early Phase Unit, Institut Claudius Regaud, Institut Universitaire du Cancer Toulouse, Toulouse, France. 9 Department of Hematology/Hematopoietic Cell Transplantation, City of Hope National Medical Center, Duarte, CA, USA. 10 Banner MD Anderson Cancer Center, Gilbert, AZ, USA. 11 Sanofi, Cambridge, MA, USA. 12 IT&M Stats for Sanofi, Neuilly sur-Seine, France. 13 Sanofi R&D Translational Medicine, Chilly-Mazarin, France. 14 Department of Hematology, University Hospital of Nantes, Nantes, France Co n text: SC Isa delivery would optimize convenience of administration. Prior results showed SC Isa administered by syringe pump has efficacy and safety profiles comparable to IV Isa; recommended Phase 2 dose (RP2D) 1400 mg (IMW21 P-20 7 ). Objecti v e: Evaluate safety, pharmacokinetics (PK), and efficacy of SC vs IV Isa+Pd D esig n : Multicenter Phase 1b study. Patie n ts: RRMM patients after  2 prior treatment lines. I n ter v e n tio n : Patients randomized 2:1 to SC1000mg or IV10mg/kg and to SC1400mg or IV. Expansion cohort was implemented with SC Isa administered at RP2D via OBDS (wearable bolus injector applied to abdomen). Mai n Outco m e Measure: Primary endpoints were safety, including injection site (IS) reactions (ISRs), and PK. Results: 56 patients were randomized and treated: 12 IV, 12 SC1000, 10 SC1400, 22 OBDS. At study entry, ISS stage II–III: IV 6 7 %, SC1000 33%, SC1400 60%, OBDS 50%. On January 20th, 2022, 33% IV, 25% SC1000, 50% SC1400, 86% OBDS patients remained on