Trial designs and endpoints for immune therapies in multiple myeloma

被引：3

作者：

Lancman, Guido ^{[1
]}

Moshier, Erin ^{[2
]}

Cho, Hearn Jay ^{[1
]}

Parekh, Samir ^{[1
]}

Richard, Shambavi ^{[1
]}

Richter, Joshua ^{[1
]}

Rodriguez, Cesar ^{[1
]}

Rossi, Adriana ^{[1
]}

Sanchez, Larysa ^{[1
]}

Jagannath, Sundar ^{[1
]}

Chari, Ajai ^{[1
]}

机构：

[1] Icahn Sch Med Mt Sinai, Tisch Canc Inst, Dept Hematol & Med Oncol, 1 Gustave L Levy Pl,Box 1185, New York, NY 10029 USA

[2] Icahn Sch Med Mt Sinai, Tisch Canc Inst, Dept Populat Hlth Sci & Policy, New York, NY 10029 USA

来源：

AMERICAN JOURNAL OF HEMATOLOGY | 2023年 / 98卷

关键词：

T-CELL THERAPY; BELANTAMAB MAFODOTIN; DEXAMETHASONE; EXPANSION; EFFICACY; DREAMM-2; OUTCOMES; CARE; BCMA;

D O I：

10.1002/ajh.26753

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

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.

引用

页码：S35 / S45

页数：11

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