Table 2

Key favourable and unfavourable effects for ixazomib in combination with lenalidomide and dexamethasone versus placebo in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy

EffectShort descriptionUnitIxazomib+LenDexPlacebo +LenDexUncertainties/strength of evidence
Favourable*PFS (median)Time from randomisation to first documentation of disease progression or death due to any cause.Months20.6
(17.02, NE)
14.7
(12.91, 17.58)
HR of 0.742 (95% CI 0.587 to 0.939) p=0.012; some uncertainty about the magnitude of the treatment effect.
OS† (median)Time from randomisation to death.MonthsNENEHR of 0.868 (95% CI:0.642 to 1.175) p=0.359;
immature data.
ORRProportion of ITT patients who achieved PR or better.%78.3
(73.7, 82.5)
71.5
(66.6, 76.1)
Unfavourable†ThrombocytopaeniaGrade ≥3 ADRs%199No uncertainties
NauseaGrade ≥3 ADRs%20
VomitingGrade ≥3 ADRs%1<1
DiarrhoeaGrade ≥3 ADRs%63
Peripheral neuropathyGrade ≥3 ADRs%22
  • *Data cut-off:30 October 2014.

  • †Data cut-off: 12 July 2015.

  • ADRs, adverse reactions; ITT, intent-to-treat; LenDex, lenalidomide and dexamethasone; NE, not estimated; ORR, overall response rate; OS, overall survival; PFS, progression-free survival; PR, partial response.