Moreau, P;
Dimopoulos, MA;
Yong, K;
Mikhael, J;
Risse, M-L;
Asset, G;
Martin, T;
(2020)
Isatuximab plus carfilzomib/dexamethasone versus carfilzomib/dexamethasone in patients with relapsed/refractory multiple myeloma: IKEMA Phase III study design.
Future Oncology
, 16
(2)
pp. 4347-4358.
10.2217/fon-2019-0431.
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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
| Type: | Article |
|---|---|
| Title: | Isatuximab plus carfilzomib/dexamethasone versus carfilzomib/dexamethasone in patients with relapsed/refractory multiple myeloma: IKEMA Phase III study design |
| Open access status: | An open access version is available from UCL Discovery |
| DOI: | 10.2217/fon-2019-0431 |
| Publisher version: | https://doi.org/10.2217/fon-2019-0431 |
| Language: | English |
| Additional information: | Copyright © 2019 Thomas Martin. This work is licensed under the Attribution-NonCommercial-NoDerivatives 4.0 Unported License. To view a copy of this license, visit http://creativecommons.org/licenses/by-nc-nd/4.0/. |
| Keywords: | carfilzomib, CD38, isatuximab, monoclonal antibody, Phase III trial, relapsed/refractory multiple myeloma, study protocol |
| UCL classification: | UCL UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences > Cancer Institute UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences > Cancer Institute > Research Department of Haematology |
| URI: | https://discovery.ucl.ac.uk/id/eprint/10091708 |
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