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

NCT04888039 | Recruiting

• 2 other identifiers: RC31/20/0482N° ID RCB: 2020-A03527-32
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Multiple Myeloma

Keywords

Multiple Myeloma; Real life; Health care pathways; Quality of life

Outcome Measures

Primary Outcomes (6)

• 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

• Transplants

  Transplants carrying out

  5 to 10 years

• Treatments discontinuation

  Reasons for treatments administered discontinuation

  5 to 10 years

• Therapeutic medical care description

  Supportive care and the type of care set up

  5 to 10 years

• Unconventional alternative medicine

  Use and description of unconventional alternative medicine

  5 to 10 years

• Outpatient support structure

  Support from an outpatient support structure (AMA)

  5 to 10 years

Secondary Outcomes (6)

• Best response (BR)

  5 to 10 years

• Progression-free Survival (PFS)

  5 to 10 years

• PFS after the second therapeutic line

  5 to 10 years

• Overall Survival (OS);

  5 to 10 years

• Quality of life (QOL) during the treatment course

  5 to 10 years

Interventions

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

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with a diagnosis of symptomatic multiple myeloma and living in the west-Occitanie region.

You may qualify if:

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

You may not qualify if:

• Patient opposed to this research
• Patient under legal protection

Sponsors & Collaborators

• University Hospital, Toulouse: lead
• Takeda: collaborator
• Sanofi: collaborator
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Study Sites (1)

IUCT-Oncopole - Toulouse University Hospital

Toulouse, West-Occitanie, 31059, France

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Aurore PERROT, MD

  IUCT-Oncopole - Toulouse University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aurore PERROT, MD

CONTACT

+33 5 31 15 64 90; perrot.aurore@iuct-oncopole.fr

Sandrine ROLLET, PM

CONTACT

+33 5 31 15 63 39; rollet.sandrine@iuct-oncopole.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2021
• First Posted: May 17, 2021
• Study Start: December 15, 2021
• Primary Completion (Estimated): June 1, 2031
• Study Completion (Estimated): June 1, 2031
• Last Updated: April 29, 2026

Record last verified: 2026-04

Locations

FR (1)