Isatuximab plus carfilzomib/dexamethasone versus carfilzomib/dexamethasone in patients with relapsed/refractory multiple myeloma: IKEMA Phase III study design.

Abstract	Although the treatment of relapsed/refractory multiple myeloma has improved dramatically over the past decade, the disease remains incurable; therefore, additional therapies are needed. Novel combination therapies incorporating monoclonal antibodies have shown significant promise. Here we describe the design of a Phase III study (NCT03275285, IKEMA), which is evaluating isatuximab plus carfilzomib and low-dose dexamethasone, versus carfilzomib/dexamethasone in relapsed/refractory multiple myeloma. The primary end point is progression-free survival. Responses are being determined by an independent review committee using 2016 International Myeloma Working Group criteria, and safety will be assessed throughout. The first patient was recruited in November 2017, and the last patient was recruited in March 2019; 302 patients have been randomized, and the study is ongoing. Clinical trial registration: NCT03275285.
Authors	Philippe Moreau, Meletios A Dimopoulos, Kwee Yong, Joseph Mikhael, Marie-Laure Risse, Gaëlle Asset, Thomas Martin
Journal	Future oncology (London, England) (Future Oncol) Vol. 16 Issue 2 Pg. 4347-4358 (Jan 2020) ISSN: 1744-8301 [Electronic] England
PMID	31833394 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial)
Chemical References	Antibodies, Monoclonal Antibodies, Monoclonal, Humanized Oligopeptides carfilzomib Dexamethasone isatuximab
Topics	Adolescent Adult Aged Aged, 80 and over Antibodies, Monoclonal (administration & dosage) Antibodies, Monoclonal, Humanized Antineoplastic Combined Chemotherapy Protocols (therapeutic use) Dexamethasone (administration & dosage) Disease-Free Survival Drug Resistance, Neoplasm Female Humans International Agencies Male Middle Aged Multiple Myeloma (drug therapy, pathology) Neoplasm Recurrence, Local (drug therapy, pathology) Oligopeptides (administration & dosage) Prospective Studies Salvage Therapy (methods) Survival Rate Young Adult

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