Real-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 (REMIX)

Study identification

• EU PAS number:
  EUPAS21443
• Study ID:
  50768
• Official title and acronym:
  Real-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 (REMIX)
• DARWIN EU® study:
  No
• Study countries:
  France
• Study description:
  REMIX 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.
• Study status:
  Finalised

Research institutions and networks

Institutions

Kappa Santé

France

Multiple centres: 60 centres are involved in the study

Study timelines

Date when funding contract was signed

Actual: 04/09/2017

Study start date

Planned: 22/12/2017

Actual: 17/01/2018

Data analysis start date

Planned: 31/01/2022

Date of interim report, if expected

Planned: 31/03/2020

Date of final study report

Planned: 31/12/2022

Actual: 18/10/2022

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Takeda France

Regulatory

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