Study type

Study topic

Human medicinal product
Disease /health condition

Study type

Non-interventional study

Scope of the study

Disease epidemiology

Data collection methods

Secondary use of data
Non-interventional study

Non-interventional study design

Cohort
Other

Non-interventional study design, other

Retrospective analysis
Study drug and medical condition

Name of medicine

KYPROLIS
VELCADE

Medical condition to be studied

Plasma cell myeloma
Population studied

Short description of the study population

Patients with multiple myeloma (MM) treated with proteasome inhibitors.
Patients eligible for this study will have received treatment for MM at one of the following institutions: Brigham & Women’s Hospital, Dana Farber Cancer Institute, or Massachusetts General Hospital, Boston. Patient cohorts will include:
a) 400 consecutive patients treated with bortezomib with MM who have received ≥ 1prior treatments, and
a) 250 consecutive patients with relapsed and/or refractory MM treated with carfilzomib, who have received ≥ 1prior treatments prior to initiating carfilzomib.
Inclusion Criteria
1. Patients with a diagnosis of MM who have received ≥ 1prior treatments prior to treatment with carfilzomib or bortezomib
2. Treatment for at least 1 cycle with bortezomib (21 day cycle) or carfilzomib (28 day cycle)
3. Age ≥ 18 years
Exclusion Criteria
1. Use of bortezomib or carfilzomib as first line treatment for MM (i.e. no prior treatment).

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)

Special population of interest

Other

Special population of interest, other

Multiple myeloma patients

Estimated number of subjects

650
Study design details

Main study objective

The aim of this observational study is to describe the differences in the incidence of CV outcomes for bortezomib- and carfilzomib- treated patients.

Outcomes

• Incidence of MACE and extended MACE in bortezomib and carfilzomib- treated patients with MM• Pre-treatment cardiovascular risk profile and overall comorbidities in bortezomib and carfilzomib-treated patients with MM, Risk factors for MACE and extended MACE in MM patients: overall, bortezomib-treated, and carfilzomib- treated

Data analysis plan

For the primary endpoint, the incidence of MACE and extended MACE will be calculated separately for bortezomib- and carfilzomib- treated patients. Incidence of MACE and extended MACE will be calculated by counting incident events in the carfilzomib-treated cohort or bortezomib-treated cohort. For the secondary objective, pre-treatment cardiovascular risk profile and overall comorbidities in bortezomib- and carfilzomib-treated patients will be compared using the Fisher Exact Test for categorical data and the Student t-test for continuous data. For the exploratory objective, risk factors for MACE and extended MACE in MM patients will be analyzed overall and for bortezomib-treated and carfilzomib- treated cohorts, separately. A generalized logistic regression model will be used to identify predictors of MACE and extended MACE.
Documents
Study results
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