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PASCA-MM Study. Impact of the PASCA (PArcours de Santé au Cours du CAncer) Program on Complications Associated With Multiple Myeloma and/or Its Treatments in the Context of a First Hematopoietic Stem Cell Autograft, in Adults Aged 18 to 70.

RecruitingNAAges 18 Years - 70 YearsAllCentre Leon Berard
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In plain words

What the trial is, and whether it could suit you

This is a prospective, multicentre, phase III, randomised, controlled intervention study. Two groups of patients with equal numbers will be studied and each patient will be allocated to one of the two groups described below by randomisation (ratio 1:1). Each patient will be allocated to one of the two groups described below by randomisation (ratio 1:1). \- PASCA interventional group For both the 7 complications of interest (primary objective) and the 13 secondary complications (secondary objective), a specific and proactive referral will be made systematically after each screening assessment, depending on the level of risk, estimated according to decision trees (management guide) and through the dedicated PASCA network of healthcare professionals, in order to initiate early treatment and follow-up if necessary. \- Control group For the 7 complications of interest (primary objective

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: 1. Age ≥ 18 years old and ≤ 70 years old. 2. Patient treated in an investigation center. 3. Symptomatic multiple myeloma eligible for autologous hematopoietic stem cell transplantation (HSCT). 4. In complete response, complete response, very good complete response, or partial before HSCT. 5. First induction-type treatment (Isa-KRD/dara-VRD/dara-VTD/VRD/VTD/dara-VRD), intensification therapy with melphalan, HSCT, consolidation, maintenance including at least one drug immunomodulator. 6. ECOG performance status WHO ≤ 2. 7. No history or coexistence of other primary cancer apart from basal cell cancer cutaneous 8. Able to understand, read and write French. 9. Having signed and dated the informed consent. Exclusion Criteria: 1. Unable to be monitored for medical, social, family, geographical or psychological, throughout the duration of the study. 2. Deprived of liberty by court or administrative decision. 3. Not affiliated with a health insurance plan. 4. Not having declared an attending physician. 5. Not domiciled in the Auvergne-Rhône-Alpes region or in the Saône-et-Loire department. 6. Not available and/or not willing to participate in the project for the entire duration of the study. 7. Pregnant women, breastfeeding women, people in emergency situations, people incapable of personally giving their consent including adults under guardianship
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What it tests

  • Interpretation of the results from the detection visit
  • Explaining detection results and referrals to the patient
  • Early medical care through the network
  • Transmission of results from each detection visit to the referring onco-haematologists - Control Group
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Where

6 sites
CH Annecy Genevois
Épagny, France
CHU La Tronche
Grenoble, France
Centre Léon Bérard
Lyon, France
CENTRE HOSPITALIER UNIVERSITAIRE de MONTPELLIER
Montpellier, France
CHU de St-Etienne
Saint-Etienne, France
Le Centre Hôpitaux Nord-Ouest Villefranche-sur-Saône
Villefranche-sur-Saône, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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