Trial designs and endpoints for immune therapies in multiple myeloma

Guido Lancman; Erin Moshier; Hearn Jay Cho; Samir Parekh; Shambavi Richard; Joshua Richter; Cesar Rodriguez; Adriana Rossi; Larysa Sanchez; Sundar Jagannath; Ajai Chari

doi:10.1002/ajh.26753

Trial designs and endpoints for immune therapies in multiple myeloma

Guido Lancman, Erin Moshier, Hearn Jay Cho, Samir Parekh, Shambavi Richard, Joshua Richter, Cesar Rodriguez, Adriana Rossi, Larysa Sanchez, Sundar Jagannath, Ajai Chari

Research output: Contribution to journal › Review article › peer-review

3 Scopus citations

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.

Original language	English
Pages (from-to)	S35-S45
Journal	American Journal of Hematology
Volume	98
Issue number	S2
DOIs	https://doi.org/10.1002/ajh.26753
State	Published - Mar 2023

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title = "Trial designs and endpoints for immune therapies in multiple myeloma",

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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T1 - Trial designs and endpoints for immune therapies in multiple myeloma

AU - Lancman, Guido

AU - Moshier, Erin

AU - Cho, Hearn Jay

AU - Parekh, Samir

AU - Richard, Shambavi

AU - Richter, Joshua

AU - Rodriguez, Cesar

AU - Rossi, Adriana

AU - Sanchez, Larysa

AU - Jagannath, Sundar

AU - Chari, Ajai

PY - 2023/3

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N2 - 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.

AB - 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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VL - 98

SP - S35-S45

JO - American Journal of Hematology

JF - American Journal of Hematology

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Trial designs and endpoints for immune therapies in multiple myeloma

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