Risk and response adapted therapy following autologous stem cell transplant in patients with newly diagnosed multiple myeloma (RADAR (UK-MRA Myeloma XV Trial): study protocol for a phase II/III randomised controlled trial.

Détails

ID Serval
serval:BIB_2A444B222761
Type
Article: article d'un périodique ou d'un magazine.
Collection
Publications
Titre
Risk and response adapted therapy following autologous stem cell transplant in patients with newly diagnosed multiple myeloma (RADAR (UK-MRA Myeloma XV Trial): study protocol for a phase II/III randomised controlled trial.
Périodique
BMJ open
Auteur⸱e⸱s
Royle K.L., Coulson A.B., Ramasamy K., Cairns D.A., Hockaday A., Quezada S., Drayson M., Kaiser M., Owen R., Auner H.W., Cook G., Meads D., Olivier C., Barnard L., Lambkin R., Paterson A., Dawkins B., Chapman M., Pratt G., Popat R., Jackson G., Bygrave C., Sive J., de Tute R., Chantry A., Parrish C., Cook M., Asher S., Yong K.
ISSN
2044-6055 (Electronic)
ISSN-L
2044-6055
Statut éditorial
Publié
Date de publication
17/11/2022
Peer-reviewed
Oui
Volume
12
Numéro
11
Pages
e063037
Langue
anglais
Notes
Publication types: Clinical Trial Protocol ; Journal Article ; Research Support, Non-U.S. Gov't
Publication Status: epublish
Résumé
Multiple myeloma is a plasma cell malignancy that accounts for 1%-2% of newly diagnosed cancers.At diagnosis, approximately 20% of patients can be identified, using cytogenetics, to have inferior survival (high-risk). Additionally, standard-risk patients, with detectable disease (minimal residual disease (MRD)-positive) postautologus stem cell transplant (ASCT), fare worse compared with those who do not (MRD-negative). Research is required to determine whether a risk-adapted approach post-ASCT could further improve patient outcomes.
RADAR is a UK, multicentre, risk-adapted, response-guided, open-label, randomised controlled trial for transplant-eligible newly diagnosed multiple myeloma patients, using combinations of lenalidomide (R), cyclophosphamide (Cy), bortezomib (Bor), dexamethasone (D) and isatuximab (Isa).Participants receive RCyBorD(x4) induction therapy, followed by high-dose melphalan and ASCT. Post-ASCT, there are three pathways as follows:A phase III discontinuation design to assess de-escalating therapy in standard-risk MRD-negative patients. Participants receive 12 cycles of Isa maintenance. Those who remain MRD-negative are randomised to either continue or stop treatment.A phase II/III multiarm multistage design to test treatment strategies for treatment escalation in standard-risk MRD-positive patients. Participants are randomised to either; R, RBorD(x4) +R, RIsa, or RBorIsaD(x4) + RIsa.A phase II design to assess the activity of intensive treatment strategies in high-risk patients. Participants are randomised to RBorD(x4) +R or RBorIsaD(x4) + RIsa.1400 participants will be registered to allow for 500, 450 and 172 participants in each pathway. Randomisations are equal and treatment is given until disease progression or intolerance.
Ethical approval was granted by the London-Central Research Ethics Committee (20/LO/0238) and capacity and capability confirmed by the appropriate local research and development department for each participating centre prior to opening recruitment. Participant informed consent is required before trial registration and reconfirmed post-ASCT. Results will be disseminated by conference presentations and peer-reviewed publications.
ISCRTN46841867.
Mots-clé
Humans, Multiple Myeloma/drug therapy, Transplantation, Autologous, Hematopoietic Stem Cell Transplantation/methods, Stem Cell Transplantation/adverse effects, Neoplasm, Residual/etiology, United Kingdom, Randomized Controlled Trials as Topic, Multicenter Studies as Topic, Clinical Trials, Phase II as Topic, Cancer genetics, Clinical trials, Myeloma, Protocols & guidelines, STATISTICS & RESEARCH METHODS
Pubmed
Web of science
Open Access
Oui
Création de la notice
02/12/2024 16:49
Dernière modification de la notice
04/12/2024 7:07
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