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.