Real-life efficacy and safety of patients treated with ixazomib in combination with lenalidomide and dexamethasone, for relapsed and/or refractory multiple myeloma: a prospective, non-interventional, real-life study (REMIX)

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Drug utilisation

  Effectiveness study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Prospective, real-life study

Study drug and medical condition

• Name of medicine:
  NINLARO
• Medical condition to be studied:
  Plasma cell myeloma

Population studied

• Short description of the study population:
  The study population involved patients with relapsed and/or refractory multiple myeloma received treatment with ixazomib in combination with lenalidomide and dexamethasone.
• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Relapsed and/or refractory multiple myeloma patients
• Estimated number of subjects:
  500

Study design details

• Main study objective:
  The primary objective is to evaluate median progression-free survival (PFS) of ixazomib in combination with lenalidomide and dexamethasone in patients treated for relapsed and/or refractory multiple myeloma
• Data analysis plan:
  This study is observational and epidemiological methods will be employed for data analyses. Descriptive analysis of qualitative and ordinal variables will comprise sample size and the frequency of each modality. All patients included in the study will be described. The reference population for the analysis of the primary endpoint will correspond to patients meeting the eligibility criteria. The safety analysis will be carried out on all patients having received at least one dose of ixazomib.For the primary endpoints, PFS will be assessed using the Kaplan-Meier method. This method will be applied to derive, survival curves, median event time and a 95% confidence interval for the median. Kaplan-Meier estimates will also be provided for sub-group analysis of interest.