Neoplasms

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Behaviors and Mental Disorders

Multiple Myeloma

Neoplasms, Plasma Cell

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Quality of Life

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 phase,
* after the maintenance phase : 1 year and 2 years after the start of the maintenance.

quality of life questionnaires (EORTC QLQ-C30 ; EORTC QLQMY20 ; EQ-5D-5L ; Cohen's stress scale)

Aurore PERROT, MD

Sandrine ROLLET, PM

Sandra BERNARD, PM

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.

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.

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

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.

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

Reasons for treatments administered discontinuation

Supportive care and the type of care set up

Use and description of unconventional alternative medicine

Support from an outpatient support structure (AMA)

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 between date of first intake of treatment until 1st progression according to the IMWG criteria or until death if it occurs before progression

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 between date of first intake of treatment and death from any cause.

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.

-SPC and grade 3 and higher neuropathies (depending on the applicable version of the CTCAE)

Institut National de la Santé Et de la Recherche Médicale, France

Takeda

Sanofi

University Hospital, Toulouse

Hematologic Neoplasms

Patients eligible for CAR-T treatment for their hemopathy at TOULOUSE University Hospital under early access or marketing authorization or as part of a clinical trial between 01/01/2019 and 31/12/2028

Patients eligible for CAR-T treatment

Pierre BORIES, MD

Sandra DE BARROS

Adoptive immunotherapy using CAR-T cells is now one of the Advanced Therapy Medicines routinely used for relapsed or refractory lymphoid hemopathies. In 2023, in France, 5 types of CAR-T cells have marketing authorization for 6 different indications. However, these marketing authorizations are based on clinical trials involving a limited number of selected patients. Real-life data are essential for assessing the post-authorization use of these innovative treatments. The French national DESCAR-T registry, promoted by LYSARC and in which Toulouse University Hospital plays an active role, is an international reference for this real-life evaluation. It does not, however, allow precise evaluation of patient-centered indicators and care pathways.

With the increasing number of indications and candidate patients, Toulouse University Hospital, the only healthcare facility authorized in the Western Occitanie region to administer CAR-T cells, is faced with growing hospital needs and longer treatment times. In 2023, this has necessitated the implementation of new ambulatory and inter-facility care pathways in collaboration with the referral centers of the Onco-Occitanie Ouest regional cancer network. The selection of patients for CAR-T cell treatment is based on objective clinical criteria linked to the pathology (histology, morphological localization, size and kinetics of the tumor mass) and the patient (physiological age, performance index, comorbidities, patient choice). Because of their innovative nature, in a difficult psychological and physical context for the patient (refractory disease), CAR-T cell care pathways also need to be evaluated in terms of their "quality of life" dimension. The impact of non-biological determinants (also described as social and territorial inequalities in health) such as place of residence and distance from healthcare provision, marital, economic and social status, has never been explored on the accessibility and progress of the CAR-T cell treatment pathway.

The creation of a registry of patients eligible for CAR-T cells at Toulouse University Hospital will enable these lines of research to be explored on the scale of a region with a population of 3 million.

Ambispective observational cohort: This observational study is monocentric. For each patient, data will be collected during 5 years.

Real-life Management of Patients Eligible for CAR-T Cell Therapy

Evaluation of the Real-life Management of Patients Eligible for CAR-T Cell Therapy for Hematologic Malignancies at Toulouse University Hospital

Overall survival from CAR-T cell injection to all-cause death

progression-free survival from CAR-T cell injection to date of progression and overall survival from CAR-T cell injection to all-cause death progression-free survival from CAR-T cell injection to date of progression and overall survival from CAR-T cell injection to all-cause death

number of days between the multidisciplinary consultation meeting and the injection of CAR-T cells

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Follow-up of Patients With Multiple Myeloma in the West-Occitanie Region "Living With a Myeloma in West-Occitanie"	NCT04888039	Multiple Myelom...	quality of life...	18 Years -	University Hospital, Toulouse
Follow-up of Patients With Multiple Myeloma in the West-Occitanie Region "Living With a Myeloma in West-Occitanie"	NCT04888039	Multiple Myelom...	quality of life...	18 Years -	University Hospital, Toulouse
Real-life Management of Patients Eligible for CAR-T Cell Therapy	NCT06369389	Hemopathy	Patients eligib...	18 Years -	University Hospital, Toulouse
Real-life Management of Patients Eligible for CAR-T Cell Therapy	NCT06369389	Hemopathy	Patients eligib...	18 Years -	University Hospital, Toulouse
Follow-up of Patients With Multiple Myeloma in the West-Occitanie Region "Living With a Myeloma in West-Occitanie"	NCT04888039	Multiple Myelom...	quality of life...	18 Years -	University Hospital, Toulouse

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Every month we try and update this database with for real life cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for real life

Every month we try and update this database with for real life cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for real life cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.