Follow-up of Patients With Multiple Myeloma in the West-Occitanie Region "Living With a Myeloma in West-Occitanie"

Официальное название

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.

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое quality of life questionnaires (EORTC QLQ-C30 ; EORTC QLQMY20 ; EQ-5D-5L ; Cohen's stress scale)
  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 : * At diagnosis (before starting 1st line of treatment), * after the induction phase (before autologous transplantation for patients who will be transplanted), * after the consolidation

Первичные конечные точки

• Treatment lines and procedures followed by the patients [Срок оценки: 5 to 10 years]
• Transplants [Срок оценки: 5 to 10 years]
• Treatments discontinuation [Срок оценки: 5 to 10 years]
• Therapeutic medical care description [Срок оценки: 5 to 10 years]
• Unconventional alternative medicine [Срок оценки: 5 to 10 years]
• Outpatient support structure [Срок оценки: 5 to 10 years]

Вторичные конечные точки (6)

• Best response (BR) [Срок оценки: 5 to 10 years]
• Progression-free Survival (PFS) [Срок оценки: 5 to 10 years]
• PFS after the second therapeutic line [Срок оценки: 5 to 10 years]
• Overall Survival (OS); [Срок оценки: 5 to 10 years]
• Quality of life (QOL) during the treatment course [Срок оценки: 5 to 10 years]
• Second primary cancers (SPC) and grade 3 and higher neuropathies [Срок оценки: 5 to 10 years]

Критерии участия

Критерии включения

• Patient living in the West-Occitanie region
• Patient with a diagnosis of symptomatic multiple myeloma (Rajkumar et al, Lancet Oncology 2014)

Критерии исключения

• Patient opposed to this research
• Patient under legal protection

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Франция · 1 центр

• IUCT-Oncopole - Toulouse University Hospital — Toulouse

Идентификаторы

NCT: NCT04888039 · RC31/20/0482 · N° ID RCB: 2020-A03527-32

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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