Impact of the PASCA Program on Complications in Multiple Myeloma Patients Undergoing Stem Cell Transplant

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness of the PASCA program in managing complications associated with multiple myeloma and its treatments during the first autologous hematopoietic stem cell transplant. Patients will be randomly assigned to either an intervention group, receiving proactive care and referrals based on screening results, or a control group, receiving standard care. The study aims to identify and address seven primary complications and thirteen secondary complications through a structured healthcare network. The approach emphasizes early intervention and standardized decision-making to improve patient outcomes.

Why it matters

Who can join: the full rules

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

Where it's running

• CH Annecy Genevois
  Épagny, France Recruiting
• CHU La Tronche
  Grenoble, France Recruiting
• Centre Léon Bérard
  Lyon, France Recruiting
• CENTRE HOSPITALIER UNIVERSITAIRE de MONTPELLIER
  Montpellier, France Recruiting
• CHU de St-Etienne
  Saint-Etienne, France Recruiting
• Le Centre Hôpitaux Nord-Ouest Villefranche-sur-Saône
  Villefranche-sur-Saône, France Recruiting

Study contacts

• Principal investigator: Mauricette MICHALLET, PhD, MD — Centre Leon Berard
• Study coordinator: Romain BUONO, PharmaD, MPH
• Email: romain.buono@lyon.unicancer.fr
• Phone: +33469856358

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.