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NCT Number: NCT04888039

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IUCT-Oncopole - Toulouse University Hospital

Toulouse, West-Occitanie, 31059, France

Location status: Recruiting

Location contact

Aurore PERROT, MD

PRINCIPAL_INVESTIGATOR

Sandra BERNARD, PM

CONTACT

[email protected]

+33 5 61 77 85 73 ext. +33

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Treatment lines and procedures followed by the 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

  2. Transplants

    Time frame: 5 to 10 years

    Transplants carrying out

  3. Treatments discontinuation

    Time frame: 5 to 10 years

    Reasons for treatments administered discontinuation

  4. Therapeutic medical care description

    Time frame: 5 to 10 years

    Supportive care and the type of care set up

  5. Unconventional alternative medicine

    Time frame: 5 to 10 years

    Use and description of unconventional alternative medicine

  6. Outpatient support structure

    Time frame: 5 to 10 years

    Support from an outpatient support structure (AMA)

Secondary outcomes

  1. Best response (BR)

    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.

  2. Progression-free Survival (PFS)

    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

  3. PFS after the second therapeutic line

    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.

  4. Overall Survival (OS);

    Time frame: 5 to 10 years

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

  5. Quality of life (QOL) during the treatment course

    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.

  6. Second primary cancers (SPC) and grade 3 and higher neuropathies

    Time frame: 5 to 10 years

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

Study contacts

Contact information is provided by the study sponsor or research team.

Aurore PERROT, MD

CONTACT

[email protected]

+33 5 31 15 64 90 ext. +33

Sandrine ROLLET, PM

CONTACT

[email protected]

+33 5 31 15 63 39 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Collaborators

  • Institut National de la Santé Et de la Recherche Médicale, France
  • Sanofi
  • Takeda

Registry information

Official study 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.

Acronym: VAMOS

Important dates

Study start
2021
Primary completion
2031
Study completion
2031
First posted
May 17, 2021
Registry last updated
Apr 29, 2026

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.

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