Myeloma XIV: Frailty-adjusted Therapy in Transplant Non-Eligible Patients With Newly Diagnosed Multiple Myeloma
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- STATUS
- Recruiting
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- End date
- Dec 23, 2024
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- participants needed
- 740
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- sponsor
- University of Leeds
Summary
Trial Title:
FiTNEss (UK-MRA Myeloma XIV) - Frailty-adjusted therapy in Transplant Non-Eligible patients with newly diagnosed Multiple Myeloma
- Overview
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.
Participant population:
- Newly diagnosed as having Multiple Myeloma (MM) according to the updated IMWG diagnostic criteria 2014 (see Appendix 1 for criteria)
- Not eligible for stem cell transplant
- Aged at least 18 years
- Able to provide written informed consent
Number of participants:
740 participants will be entered into the trial at Randomisation 1 (R1), with 478 participants at Randomisation 2 (R2).
- Objectives
The primary objectives of this study are to determine:
- Early treatment cessation (within 60 days of randomisation) for standard versus frailty-adjusted up-front dosing
- Progression-free survival (PFS, from maintenance randomisation) for lenalidomide + placebo (R) versus lenalidomide + ixazomib (R+I)
The secondary objectives of this study are to assess progression-free survival (PFS) for standard versus frailty-adjusted up-front dosing reductions, time to progression, time to 2nd PFS event (PFS2), overall survival (OS), survival after progression, deaths within 12 months of R1, overall response rate (ORR), attainment of VGPR, attainment of MRD negativity, duration of response, time to improved response, time to next treatment, treatment compliance and total amount of therapy delivered, toxicity & safety including the incidence of SPMs, Quality of Life (QoL), cost effectiveness of standard versus frailty-adjusted up-front dosing of IRD and cost-effectiveness of R + I versus R.
Exploratory objectives are prospective validation of a novel frailty risk score (UK-MRA Myeloma Risk Profile - MRP), usefulness of Karnofsky Performance Status (PS), and association of molecular subgroups with response, PFS and OS.
Details
| Condition | Lymphoproliferative disorders, Lymphoproliferative Disorder, Multiple Myeloma, multiple myeloma (mm) |
|---|---|
| Treatment | R1: Ixazomib, Lenalidomide, Dexamethasone (IRD) induction therapy - reactive arm, R1: Ixazomib, Lenalidomide, Dexamethasone (IRD) induction therapy - adaptive arm, R2: Lenalidomide plus placebo maintenance, R2: Lenalidomide + ixazomib maintenance |
| Clinical Study Identifier | NCT03720041 |
| Sponsor | University of Leeds |
| Last Modified on | 23 June 2021 |
Eligibility
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