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

Multiple Myeloma Clinical Trial

— VAMOS  

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04888039
• Other study ID #: RC31/20/0482
• Secondary ID: N° ID RCB: 2020-
• Status: Recruiting
• Start date: December 15, 2021
• Est. completion date: June 2031

Study information

• Verified date: May 2023
• Source: University Hospital, Toulouse
• Contact: Aurore PERROT, MD
• Phone: +33 5 31 15 64 90
• Email: perrot.aurore[@]iuct-oncopole.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: June 2031
• Est. primary completion date: June 2031
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient living in the West-Occitanie region

• Patient with a diagnosis of symptomatic multiple myeloma (Rajkumar et al, Lancet Oncology 2014)

Exclusion Criteria:

• Patient opposed to this research

• Patient under legal protection

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

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

Locations

Country	Name	City	State
France	IUCT-Oncopole - Toulouse University Hospital	Toulouse	West-Occitanie

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital, Toulouse	Institut National de la Santé Et de la Recherche Médicale, France, Sanofi, Takeda

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment lines and procedures followed by the patients	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	5 to 10 years
Primary	Transplants	Transplants carrying out	5 to 10 years
Primary	Treatments discontinuation	Reasons for treatments administered discontinuation	5 to 10 years
Primary	Therapeutic medical care description	Supportive care and the type of care set up	5 to 10 years
Primary	Unconventional alternative medicine	Use and description of unconventional alternative medicine	5 to 10 years
Primary	Outpatient support structure	Support from an outpatient support structure (AMA)	5 to 10 years
Secondary	Best response (BR)	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.	5 to 10 years
Secondary	Progression-free Survival (PFS)	Time between date of first intake of treatment until 1st progression according to the IMWG criteria or until death if it occurs before progression	5 to 10 years
Secondary	PFS after the second therapeutic line	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.	5 to 10 years
Secondary	Overall Survival (OS);	Time between date of first intake of treatment and death from any cause.	5 to 10 years
Secondary	Quality of life (QOL) during the treatment course	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.	5 to 10 years
Secondary	Second primary cancers (SPC) and grade 3 and higher neuropathies	-SPC and grade 3 and higher neuropathies (depending on the applicable version of the CTCAE)	5 to 10 years