Myeloma XIV: Frailty-adjusted Therapy in Transplant Non-Eligible Patients With Newly Diagnosed Multiple Myeloma

What the source actually supports

Evidence stage

Phase 3

Study design

RANDOMIZED · PARALLEL · TREATMENT · QUADRUPLE

Evidence population

Human clinical study registration

Participants

740

Population

ALL · 18 Years

Duration

2020-08-04 to 2024-12-01

Intervention

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

Comparator

R1: IRD induction therapy (reactive); R2: Lenalidomide plus placebo maintenance

Outcomes measured

Randomisation 1: Number of participants with early treatment cessation — Within 60 days of Randomisation 1; Randomisation 2: Progression-free survival (PFS-R2) — The time from the date of Randomisation 2 to the date of first do…; Progression-free survival (PFS-R1) — The time from the date of Randomisation 1 to the date of first documented evidence…; Time to disease progression — The time from the date of randomisation to the date of first documented evidence of disea…; Progression-free survival two (PFS2) — The time from the date of randomisation to the date of the second documented dis…; Overall survival (OS) — The time from the date of randomisation to the date of death from any cause, up to 120 months; Survival after progression — The date of first documented evidence of disease progression to the date of death from any…; Deaths within 12 months of Randomisation 1 (R1) — Within 12 months of Randomisation 1; Overall response rate (ORR) — From the date of Randomisation 1 to the end of 12 cycles of induction treatment (each ind…; Attainment of ≥VGPR — From the date of Randomisation 1 to the end of 12 cycles of induction treatment (each induction c…; Attainment of Minimal Residual Disease (MRD) negativity — From the date of Randomisation 1 to the end of 12 cycles of i…; Duration of response (DoR) — The time from the date of the first observation of response ≥ Partial Response following R…; Time to improved response — The time from the date of Randomisation 2 to the date the response category is first improv…; Time to next treatment — The time from the date of Randomisation 1 to the start date of the next line of treatment or d…; Treatment compliance and total amount of therapy delivered — Number of induction and maintenance cycles a participant r…; Incidence of treatment-emergent adverse events (Toxicity and safety, including incidence of second malignancies) — Base…; EORTC QLQ-C30_questionnaire — Randomisation 1; after cycles 2, 4, 6 and 12 of induction treatment (each induction cycle…; EORTC QLQ-MY20_questionnaire — Randomisation 1; after cycles 2, 4, 6 and 12 of induction treatment (each induction cycl…; EQ-5D-3L_questionnaire — Randomisation 1; after cycles 2, 4, 6 and 12 of induction treatment (each induction cycle is 2…

Reported result

No reusable finding-level result is available in this record.