Retrospective Analysis of Second Primary Malignancies (SPM) Data From ASPIRE and ENDEAVOR Studies (20220146)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Clinical study databases of ASPIRE and ENDEAVOR.

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Retrospective, post hoc analysis of two Phase 3 randomized controlled trials of carfilzomib-based regimen vs non-carfilzomib regimen.

Study drug and medical condition

• Name of medicine:
  KYPROLIS
• Study drug International non-proprietary name (INN) or common name:
  CARFILZOMIB
• Medical condition to be studied:
  Plasma cell myeloma

Population studied

• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  1700

Study design details

• Main study objective:
  The main objective of this study is to describe the incidence rates of SPM in each arm of ASPIRE and ENDEAVOR.
• Outcomes:
  • Overall participant incidence of SPM and SPM by categories of solid tumor (skin or non-skin cancer), hematologic malignancies, or other non-specified malignancies. ; • Exposure-adjusted incidence rate of SPM and SPM by category. ; • Time to onset of SPM. ; • Outcome of SPM. ; • Baseline demographic and disease characteristics.
• Data analysis plan:
  The descriptive statistics will be provided by treatment arm for participants with SPM & without SPM. Continuous variables are summarized by non-missing sample size, mean, standard deviation, median, interquartile range, minimum, maximum. Categorical variables are summarized by number of participants & percentage in each category. ; Malignant tumors standardized MedDRA query (SMQ) & tumors of unspecified malignancy SMQ are used in adverse events data search to identify participants with SPM. ; Participant incidence of SPM & SPM by category (solid tumor skin/non-skin cancer, hematologic malignancies, or other non-specified) will be summarized based on the listing. Outcomes of SPMs will be summarized by arms.