NCT03720041: Phase 3 Myeloma XIV: Frailty-adjusted Therapy in Transplant Non-Elig. New MM (FiTNEss)
Updated: Oct 4, 2022
Myeloma XIV: Frailty-adjusted Therapy in Transplant Non-Eligible Patients With Newly Diagnosed Multiple Myeloma (FiTNEss)
FiTNEss (UK-MRA Myeloma XIV) - Frailty-adjusted therapy in Transplant Non-Eligible patients with newly diagnosed Multiple Myeloma
A phase III, multi-centre, randomised controlled trial to compare standard (reactive) and frailty-adjusted (adaptive) induction therapy delivery with the novel triplet ixazomib, lenalidomide and dexamethasone (IRD), and to compare maintenance lenalidomide (R) to lenalidomide plus ixazomib (R+I) in patients with newly diagnosed multiple myeloma not suitable for a stem cell transplant.
All participants receive induction treatment with ixazomib, lenalidomide and dexamethasone and are randomised on a 1:1 basis at trial entry to the use of frailty score-adjusted up-front dose reductions vs. standard up-front dosing followed by toxicity dependent reactive dose-modifications during therapy. Following 12 cycles of induction treatment participants alive and progression-free undergo a second randomisation on a 1:1 basis to maintenance treatment with lenalidomide plus placebo versus lenalidomide plus ixazomib. Participants and their treating physicians will be blinded to maintenance allocation.
Sponsor:
Collaborators:
Multiple Locations
UK study
ClinicalTrials.gov Identifier: NCT03720041
Official Title: Myeloma XIV: A Phase III Trial to Compare Standard and Frailty-adjusted Induction Therapy With Ixazomib, Lenalidomide and Dexamethasone (IRD) and Maintenance Lenalidomide (R) to Lenalidomide Plus Ixazomib (R+I)
First Posted : October 25, 2018
Click here for details on ClinicalTrials.gov
Drug: R1: Ixazomib, Lenalidomide, Dexamethasone (IRD) induction therapy - reactive arm
Drug: R1: Ixazomib, Lenalidomide, Dexamethasone (IRD) induction therapy - adaptive arm
Drug: R2: Lenalidomide plus placebo maintenance
Drug: R2: Lenalidomide + ixazomib maintenance
81 Fitness, a UK Myeloma Research Alliance (UK-MRA) Frailty-Adjusted Therapy Study, Supports the Feasibility of Recruiting Frail Newly Diagnosed Myeloma Patients to Large Clinical Trials
Program: Oral and Poster Abstracts
Type: Oral
Session: 653. Myeloma and Plasma Cell Dyscrasias: Clinical-Prospective Therapeutic Trials: Phase 2 and 3 Trials in Myeloma
Hematology Disease Topics & Pathways:
Clinical Trials, Age Inequities, Clinical Research, Plasma Cell Disorders, Clinically Relevant, Diseases, Therapies, Lymphoid Malignancies, Diversity, Equity, and Inclusion (DEI), Clinical Practice (e.g. Guidelines, Health Outcomes and Services, and Survivorship, Value; etc.)
Saturday, December 11, 2021: 10:00 AM
Locations
United Kingdom
University of Leeds
Principal Investigator: Gordon Cook, MD University of Leeds
Principal Investigator: Graham Jackson, MD Freeman Hospital, Newcastle-Upon-Tyne
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