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Multiple MyelomaVAMOSNCT04888039

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

An observational study of Multiple Myeloma, run by University Hospital, Toulouse at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Myeloma
What is being tested?
quality of life questionnaires (EORTC QLQ-C30 ; EORTC QLQMY20 ; EQ-5D-5L ; Cohen's stress scale)
How many people
2,000 participants
Where
1 siteFrance
Study dates
15 Dec 2021to Jun 2031
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • Patient opposed to this research
  • Patient under legal protection

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Aurore PERROT, MD contact

+33 5 31 15 64 90 ext. +33

perrot.aurore@iuct-oncopole.fr

Sandrine ROLLET, PM contact

+33 5 31 15 63 39 ext. +33

rollet.sandrine@iuct-oncopole.fr

France1 site, 1 recruiting

  • IUCT-Oncopole - Toulouse University Hospital

    Toulouse, West-Occitanie, 31059

    Sandra BERNARD, PM, +33 5 61 77 85 73 ext. +33, bernard.s@chu-toulouse.fr

    Aurore PERROT, MD

    Recruiting

Other trials in France

About this study

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.

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.

Read more

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.

Read the detailed 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.

Being tested
quality of life questionnaires (EORTC QLQ-C30 ; EORTC QLQMY20 ; EQ-5D-5L ; Cohen's stress scale)
Keywords
Multiple Myeloma, Real life, Health care pathways, Quality of life
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 5 to 10 years

  2. Transplants

    Transplants carrying out

    Measured: 5 to 10 years

  3. Treatments discontinuation

    Reasons for treatments administered discontinuation

    Measured: 5 to 10 years

  4. Therapeutic medical care description

    Supportive care and the type of care set up

    Measured: 5 to 10 years

  5. Unconventional alternative medicine

    Use and description of unconventional alternative medicine

    Measured: 5 to 10 years

  6. Outpatient support structure

    Support from an outpatient support structure (AMA)

    Measured: 5 to 10 years

Secondary outcomes (6)

  1. 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.

    Measured: 5 to 10 years

  2. 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

    Measured: 5 to 10 years

  3. 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.

    Measured: 5 to 10 years

  4. Overall Survival (OS);

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

    Measured: 5 to 10 years

  5. 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.

    Measured: 5 to 10 years

  6. 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)

    Measured: 5 to 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 May 2021
  2. Study start15 Dec 2021
  3. Primary completionJun 2031 (estimated)
  4. Study completionJun 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
2,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04888039
Sponsor's protocol ID
RC31/20/0482
Other IDs
N° ID RCB: 2020-A03527-32
Acronym
VAMOS
Status last verified
Apr 2026
First submitted
4 May 2021
Last updated
29 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Multiple Myeloma, run by University Hospital, Toulouse at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Aurore PERROT, MD (+33 5 31 15 64 90 ext. +33, perrot.aurore@iuct-oncopole.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment lines and procedures followed by the patients (time frame: 5 to 10 years). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04888039.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.

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