Malignancies in Multiple Sclerosis: Multi-country cohort database studies – French Study (MALBEC)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/48836
• EU PAS number:
  EUPAS26535
• Study ID:
  48836
• Official title and acronym:
  Malignancies in Multiple Sclerosis: Multi-country cohort database studies – French Study (MALBEC)
• DARWIN EU® study:
  No
• Study countries:
  France
• Study description:
  Disease Modifying Drugs (DMD) are used in the therapeutic management of Multiple Sclerosis (MS) to reduce the frequency of relapses and delay the progression of the disease. In the oral cladribine development program, efficacy data showed a significant effect of cladribine with a decrease in the frequency of relapses, associated lesions, and progression of MS. However, the safety results of the CLARITY Phase III pivotal study, evaluating cladribine versus placebo treatment in MS patients, revealed 4 cases of cancer in cladribine treated patients and no case in the placebo group. Taking into account safety and efficacy data, the European Medicines Agency Committee for Medicinal Products for Human Use issued a favourable marketing authorization opinion in June 2017 for cladribine in MS indication and conditioned by the achievement of a risk management plan defining cancer as a significant potential risk. In this context, the MALBEC study purpose is to supplement existing data by providing estimates of cancer incidence in the general population and in MS patients, whether or not treated with DMD, before the launch of cladribine (main objective). This study based on French nationwide healthcare insurance system database (SNDS) with data from the general scheme is part of a study program performed in three other countries (Denmark, the Netherlands, and the United States). The cohort will include all patients with a MS diagnosis, identified between 2007 and 2015 (inclusion date) by using hospitalization for MS, long term disease status or disability allowance with a diagnosis code of MS, or dispensing of DMD specific to MS, with a follow-up until the first date of death, occurrence of malignancy, or end of study period (31 Dec. 2015), and 1-year history prior inclusion date in the database. The crude annual incidence rates (exact Poisson) and standardized incidence rates will be calculated and stratified by age, gender, history of malignancy.
• Study status:
  Finalised

Research institutions and networks

Institutions

Bordeaux PharmacoEpi, University of Bordeaux

France

Study timelines

Date when funding contract was signed

Actual: 01/06/2018

Study start date

Planned: 01/05/2019

Actual: 18/07/2019

Data analysis start date

Planned: 01/05/2019

Actual: 18/07/2019

Date of final study report

Planned: 30/09/2020

Actual: 05/02/2021

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Merck KGaA

Study protocol

Initial protocol

MALBEC SNDS Protocol-v3.0-20190124

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable