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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Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
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Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Observational |
| Eligible Ages | 18 Years and Over |
| Gender | All |
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Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT04888039 |
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Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
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Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
University Hospital, Toulouse |
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Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Aurore PERROT, MD |
| Principal Investigator Affiliation | IUCT-Oncopole - Toulouse University Hospital |
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Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Other, Industry |
| Overall Status | Recruiting |
| Countries | France |
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Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Multiple Myeloma |
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
