The MUK eight protocol: a randomised phase II trial of cyclophosphamide and dexamethasone in combination with ixazomib,
- PDF / 1,273,291 Bytes
- 11 Pages / 595.276 x 790.866 pts Page_size
- 12 Downloads / 211 Views
STUDY PROTOCOL
Open Access
The MUK eight protocol: a randomised phase II trial of cyclophosphamide and dexamethasone in combination with ixazomib, in relapsed or refractory multiple myeloma (RRMM) patients who have relapsed after treatment with thalidomide, lenalidomide and a proteasome inhibitor Samantha Hinsley1, Katrina Walker1* , Debbie Sherratt1, Lucy Bailey1, Sadie Reed1, Louise Flanagan1, Sophie McKee1, Fiona Brudenell Straw1, Bryony Dawkins2, David Meads2, Holger W. Auner3, Martin F. Kaiser4, Mark Cook5, Sarah Brown1, Gordon Cook6 and on behalf of the Myeloma UK Clinical Trials Network
Abstract Background: Multiple myeloma is a plasma cell tumour with approximately 5500 new cases in the UK each year. Ixazomib is a next generation inhibitor of the 20S proteasome and is thought to be an effective treatment for those who have relapsed from bortezomib. The combination of cyclophosphamide and dexamethasone (CD) is a recognised treatment option for patients with relapsed refractory multiple myeloma (RRMM) who have relapsed after treatment with bortezomib and lenalidomide, whilst also often being combined with newer proteasome inhibitors. The most apparent combination for ixazomib is therefore with CD. (Continued on next page)
* Correspondence: [email protected] 1 Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK Full list of author information is available at the end of the article © The Author(s). 2020 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
Hinsley et al. Trials
(2020) 21:826
Page 2 of 11
(Continued from previous page)
Methods: MUK eight is a randomised, controlled, open, parallel group, multi-centre phase II trial that will recruit patients with RRMM who have relapsed after treatment with thalidomide, lenalidomide, and a proteasome inhibitor. The primary objective of the trial is to evaluate whether ixazomib in combination with cyclophosphamide and dexamethasone (ICD) has improved clinical activity compared to CD in terms of progression-
Data Loading...
