Study type

Study type

Non-interventional study
Study drug and medical condition

Study drug International non-proprietary name (INN) or common name

IDECABTAGENE VICLEUCEL

Anatomical Therapeutic Chemical (ATC) code

(L01XL07) idecabtagene vicleucel
idecabtagene vicleucel

Additional medical condition(s)

Relapsed and Refractory Multiple Myeloma
Population studied

Short description of the study population

The study population will include 200 patients with RRMM aged ≥18 years who are eligible and intended for ide-cel therapy based on the local prescribing information (approved label), clinical guidelines, physician assessment and institutional protocols.

Age groups

  • Adult and elderly population (≥18 years)

Estimated number of subjects

200
Study design details

Study design

This is a multi-center, real-world, observational cohort study that will be conducted across CAR T administering centers in the EU and US. This study will utilize the collection of data from patients with RRMM intended for treatment with ide-cel in the postmarketing setting.

Main study objective

The primary objective of this observational study is to assess the proportion of leukapheresed patients with relapsed and refractory multiple myeloma (RRMM) who receive an infusion with commercial idecabtagene vicleucel (ide-cel) in the real-world setting.

Data analysis plan

Real-world data including demographic, clinical, and treatment data will be collected from CART administration centers in the EU and US that are enrolling RRMM patients for treatment with ide-cel. This study may apply primary data collection. Additionally, existing data collected in independent registries may also be used. The proportion of patients who receive ide-cel infusion within 6months of leukapheresis will be reported from the collected data. Its associated 95% Clopper-Pearson confidence interval will be computed. The same calculation will be performed for the high-risk and standard-risk subgroups, separately.