Table 1.
Randomisation 1 | |||
Treatment | Induction—FIT+induction—standard dosing | Induction—unfit | Induction—frail |
Lenalidomide (days=1–21) | 25 mg | 15 mg | 10 mg |
Ixazomib (days=1, 8, 15)* | 4 mg | 4 mg | 4 mg |
Dexamethasone †(days=1, 8, 15, 22) | 40 mg in participants≤75 years 20 mg in participants>75 years |
20 mg | 10 mg |
Randomisation 2 | ||
Treatment | Lenalidomide+placebo maintenance | Lenalidomide+ixazomib maintenance |
Lenalidomide (days=1–21) | 10 mg† | 10 mg† |
Ixazomib (days=1, 8, 15)* | N/A | 4 mg† |
Placebo (days=1, 8, 15) | 4 mg† | N/A |
*Ixazomib was not used in general multiple myeloma practice at the time of the European Myeloma Network publication. The following licensed dose of Ixazomib will be used for both randomisation arms: 4 mg, at days 1, 8 and 15. This has been studied in patients who are not eligible for transplant and was well tolerated. There have been no studies examining lower doses of Ixazomib so dose reductions are not permitted out of concern for loss of efficacy. The same dose is used irrespective of frailty.
†Or final dose administrated at the end of induction treatment if lower.