IONA-MM
Research type
Research Study
Full title
A non-interventional, multinational, observational study with isatuximab in patients with relapsed and/or refractory multiple myeloma (RRMM)
IRAS ID
282210
Contact name
Martin Kaiser
Contact email
Sponsor organisation
Sanofi Aventis Recherche Développement
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
4 years, 8 months, 17 days
Research summary
The purpose of this study is to understand the effectiveness, safety and quality of life in patients with relapsed and/or refractory multiple myeloma (also called “RRMM”) who are prescribed Isatuximab according to routine care. This is a non-interventional study, i.e. a research that aims to collect data over time on how a certain treatment is used as well as its effects, without any change to normal care. This means that routine clinical practice is followed. Any treatment given follows normal routine too. It is planned that 1200 patients will participate in this study, at up to 150 sites in 16 countries.
This study will not alter or interfere with the normal care the patient would receive in any way. In addition, if patient started Isatuximab treatment after enrolling in the study, two questionnaires will be collected when patient attends regular doctor’s visits. Each questionnaire which should take you approximately 10-15 minutes to complete. These questionnaires will be administered by electronical means, or by paper if the electronic mode is not available. For those patients who started Isatuximab treatment before being enrolled into this study, no questionnaires apply and the only information required will be collected from the patients' medical chart.REC name
East of England - Cambridge East Research Ethics Committee
REC reference
21/EE/0295
Date of REC Opinion
13 May 2022
REC opinion
Further Information Favourable Opinion