IUCT-Oncopole - Toulouse University Hospital
Toulouse, West-Occitanie, 31059, France
Location status: Recruiting
NCT Number: NCT04888039
Actually very few real life data are available for patients with multiple myeloma (MM), whereas they're playing a more and more important role in health care decisions. Treatments choice for medical care of patient with MM depends of their age, their general status, their eligibility to high dose treatment (autograft), and also based on cytogenetic risk (standard/high risk). Therapeutic strategies are multiple and based on drugs associations including proteasome inhibitors, immuno-modulators and monoclonal antibodies.
Therapeutic medical care objective is to improve quality and response duration through more effective induction schemas, systematic consolidation for patients who have undergone high dose therapy and/or maintenance treatment, ensuring patients safety and well-being in the health care pathway.
Quality of life evaluation has to take in consideration disease outcome and secondary effects impact from treatments prescribed for MM.
With clinical trials, new therapeutic strategies are proposed with innovative drugs but participants are selected and do not represent all patients with MM. Therefore, there is a large gap between clinical trials and real life data.
That's why the CHU Toulouse intends to set up a prospective cohort to evaluate the health care pathway of patients with MM in West-Occitanie region and studies impact of treatments prescribed on the disease and on the patients' quality of life.
With this research, standard of care practices for patients with MM will be followed, prognostic scores and clinical trials results will be validated in real life, impact of outpatient support procedure will be assessed (AMA procedure) and sociodemographic/quality of life data will be available for research teams.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Toulouse, West-Occitanie, 31059, France
Location status: Recruiting
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 :
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Excepted the delivery of quality of life questionnaires (a maximum of 5 times during the course of treatment) specific to this study, only the data available during the course of patient care will be collected.
The quality of life questionnaires and the perceived stress questionnaire will be given to patients :
Time frame: 5 to 10 years
Different treatment lines and procedures followed by the patients with drugs involved, number of cycles performed in each treatment phase (induction, consolidation, maintenance) and for each therapeutic line
Time frame: 5 to 10 years
Transplants carrying out
Time frame: 5 to 10 years
Reasons for treatments administered discontinuation
Time frame: 5 to 10 years
Supportive care and the type of care set up
Time frame: 5 to 10 years
Use and description of unconventional alternative medicine
Time frame: 5 to 10 years
Support from an outpatient support structure (AMA)
Time frame: 5 to 10 years
BR evaluated according to IMWG criteria at each treatment line. This takes into account the MRD as part of the response criteria since this date.
Time frame: 5 to 10 years
Time between date of first intake of treatment until 1st progression according to the IMWG criteria or until death if it occurs before progression
Time frame: 5 to 10 years
Time between date of 1st dose of treatment until 2nd progression according to the IMWG criteria or until death if it occurs before the 2nd progression.
Time frame: 5 to 10 years
Time between date of first intake of treatment and death from any cause.
Time frame: 5 to 10 years
QOL assessed by the EORTC questionnaires QLQ-C30, QLQMY20 and EQ-5D-5L, at the start of treatment then at the end of induction and consolidation periods and once a year for patients undergoing maintenance for the first 2 lines of treatment.
Time frame: 5 to 10 years
-SPC and grade 3 and higher neuropathies (depending on the applicable version of the CTCAE)
Contact information is provided by the study sponsor or research team.
Aurore PERROT, MD
CONTACT
+33 5 31 15 64 90 ext. +33
Sandrine ROLLET, PM
CONTACT
+33 5 31 15 63 39 ext. +33
University Hospital, Toulouse
Other
Therapeutic and Support Oncologic Medical Care Evaluation in Patients With Multiple Myeloma in West-Occitanie Region. Factors Influencing Medical Care and Predictive and Prognostic Impact.
Acronym: VAMOS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06500884
Blood Protein Disorders, Cardiovascular Diseases
San Francisco, California, United States
View Trial DetailsNCT06768489
Blood Protein Disorders, Cardiovascular Diseases
Clayton, Australia
View Trial DetailsNCT01676805
Blood Protein Disorders, Cardiovascular Diseases
Bethesda, Maryland, United States
View Trial DetailsNCT06152575
Blood Protein Disorders, Cardiovascular Diseases
Mobile, Alabama, United States
View Trial Details