Trial designs and endpoints for immune therapies in multiple myeloma.

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. © 2022 Wiley Periodicals LLC.

Citation

Guido Lancman, Erin Moshier, Hearn Jay Cho, Samir Parekh, Shambavi Richard, Joshua Richter, Cesar Rodriguez, Adriana Rossi, Larysa Sanchez, Sundar Jagannath, Ajai Chari. Trial designs and endpoints for immune therapies in multiple myeloma. American journal of hematology. 2023 Mar;98 Suppl 2:S35-S45

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PMID: 36200130

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