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Trial designs and endpoints for immune therapies in multiple myeloma.
Lancman, Guido; Moshier, Erin; Cho, Hearn Jay; Parekh, Samir; Richard, Shambavi; Richter, Joshua; Rodriguez, Cesar; Rossi, Adriana; Sanchez, Larysa; Jagannath, Sundar; Chari, Ajai.
Affiliation
  • Lancman G; Department of Hematology and Medical Oncology, Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York City, New York, USA.
  • Moshier E; Department of Population Health Science and Policy, Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York City, New York, USA.
  • Cho HJ; Department of Hematology and Medical Oncology, Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York City, New York, USA.
  • Parekh S; Department of Hematology and Medical Oncology, Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York City, New York, USA.
  • Richard S; Department of Hematology and Medical Oncology, Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York City, New York, USA.
  • Richter J; Department of Hematology and Medical Oncology, Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York City, New York, USA.
  • Rodriguez C; Department of Hematology and Medical Oncology, Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York City, New York, USA.
  • Rossi A; Department of Hematology and Medical Oncology, Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York City, New York, USA.
  • Sanchez L; Department of Hematology and Medical Oncology, Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York City, New York, USA.
  • Jagannath S; Department of Hematology and Medical Oncology, Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York City, New York, USA.
  • Chari A; Department of Hematology and Medical Oncology, Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York City, New York, USA.
Am J Hematol ; 98 Suppl 2: S35-S45, 2023 03.
Article in En | MEDLINE | ID: mdl-36200130
ABSTRACT
Immune therapies, including CAR-T cells, bispecific antibodies, and antibody-drug conjugates, are revolutionizing the treatment of multiple myeloma. In this review, we discuss clinical trial design considerations relevant to immune therapies. We first examine issues pertinent to specific populations, including elderly, patients with renal impairment, high-risk/extramedullary disease, and prior immune therapies. We then highlight trial designs to optimize the selection of dose and schedule, explore rational combination therapies based on preclinical data, and evaluate the nuances of commonly used endpoints. By exploiting their pharmacokinetic/pharmacodynamic profiles and utilizing novel translational insights, we can optimize the use of immune therapies in multiple myeloma.
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Antibodies, Bispecific / Immunoconjugates / Multiple Myeloma Limits: Aged / Humans Language: En Journal: Am J Hematol Year: 2023 Document type: Article Affiliation country: United States
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Antibodies, Bispecific / Immunoconjugates / Multiple Myeloma Limits: Aged / Humans Language: En Journal: Am J Hematol Year: 2023 Document type: Article Affiliation country: United States