Status: Planned First registered on: 27/10/2017
Last updated on: 10/11/2017
1. Study identification
EU PAS Register NumberEUPAS21443
Official titleReal-life efficacy and safety of patients treated with ixazomib in combination with lenalidomide and dexamethasone, for relapsed and/or refractory multiple myeloma: a prospective, non-interventional, real-life study
Study title acronymREMIX
Study typeObservational study
Brief description of the studyREMIX is a non-interventional, multicentre study conducted in France in sites specialized in the management of multiple myeloma. It aims to evaluate ixazomib use in combination with lenalidomide and dexamethasone in real life within its market authorization. The primary objective is to evaluate median progression-free survival (PFS) of ixazomib in combination with lenalidomide and dexamethasone in patients treated for relapsed and/or refractory multiple myeloma. Secondary objectives are to evaluate mPFS and overall survival rate of these patients at different time points (i.e. 12, 24 and 36 months), to evaluate response to treatment, to describe the safety of these patients and the health care resource use of these patients for management of multiple myeloma. Analyzes will be made globally and according to subgroups of interest (age of patients, number of previous line of treatment, presence or absence of renal failure, presence of comorbidities, participation or not in compassionate use program). A total number of 500 patients is expected in the study. Patients will be followed up for a minimum duration of 24 months (for the last patient in). Patients' follow-up will be continued up to the end of the study or death, to collect long-term efficacy and safety data (total follow-up duration between 24 and 48 months). Response and progression will be evaluated periodically and will be determined by the study site on the basis of assessments at its disposal. Visits will be completed every 3 months during the first 24 months then every 6 months after 24 months as per standard practice at sites.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)? Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsKappa Santé
Department/Research groupKappa Santé
Organisation/affiliationKappa Santé
Website/Homepagewww.kappasante.com
Details of (Primary) lead investigator
Title Dr
Last name SCHÜCK
First name Stéphane
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?60
Countries in which this study is being conducted
National study

France
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed04/09/2017
Start date of data collection22/12/2017
Start date of data analysis31/01/2022
Date of interim report, if expected31/03/2020
Date of final study report31/12/2022
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesTakeda France100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name SCHÜCK
First name Stéphane
Address line 14 rue de Cléry
Address line 2 
Address line 3 
CityParis 
Postcode75002 
CountryFrance
Phone number (incl. country code)0033144827474 
Alternative phone number 
Fax number (incl. country code) 
Email address stephane.schuck@kappasante.com
Public Enquiries
Title Dr 
Last name SCHÜCK 
First name Stéphane 
Address line 14 rue de Cléry 
Address line 2 
Address line 3 
CityParis 
Postcode75002 
CountryFrance 
Phone number (incl. country code)0033144827474 
Alternative phone number 
Fax number (incl. country code) 
Email address stephane.schuck@kappasante.com 
Top