Follow-up of Patients With Multiple Myeloma in the West-Occitanie Region "Living With a Myeloma in West-Occitanie"
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Multiple Myeloma
- Type
- Observational
- Design
- Observational Model: CohortTime Perspective: Retrospective
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Primary objective : Describe health care pathways of patients with MM living in West Occitanie according to socio-demographic patients' caracteristics, their comorbidities and their initial disease severity. These pathways will be described until the patients' death if the death occurs before the en...
Primary objective : Describe health care pathways of patients with MM living in West Occitanie according to socio-demographic patients' caracteristics, their comorbidities and their initial disease severity. These pathways will be described until the patients' death if the death occurs before the end of their follow-up in this study. Secondary objectives : The best response at each line of therapy The progression free survival and overall survival Quality of life of patients with MM along their health care pathway Second primary malignancy and neuropathy grade 3 or more occurrence during patients'care Socio-demographic, clinic and biology factors identification to predict response to treatments, progression free survival, overall survival and quality of life. Study size calculation : With the hypothesis of 80% of patients informed about the study will agree to participate and will accept to have their health care data collected, and with 500 to 550 patients' medical files presented each year for MM care to West Occitanie multidisciplinary committee meeting (approximately 400 different patients), a 5-years recruitment period will lead to 1600 patients enrollment. This size will be able to generate enough precisions for descriptive analyses. Indeed, as example, with a percentage of 50%, conservative situation to estimate percentages, expected precision should be more or less 2.5% according to Clopper-Pearson exact method. Precision of more or less 5% should be also obtained for sub-groups of 400 persons.
Tracking Information
- NCT #
- NCT04888039
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Takeda
- Sanofi
- Investigators
- Principal Investigator: Aurore PERROT, MD IUCT-Oncopole - Toulouse University Hospital