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.

Launched by CENTRE LEON BERARD · Jul 7, 2023

Keywords

ClinConnect Summary

The PASCA-MM study is looking at how a special program, called PASCA, can help manage complications that may arise from multiple myeloma and its treatments after a specific type of blood stem cell transplant. The study involves two groups of patients: one group will receive extra support and early treatment for potential complications, while the other group will receive standard care. Both groups will have regular check-ups to monitor their health and catch any issues early.

To be eligible for the trial, participants must be adults aged between 18 and 70 who have been diagnosed with symptomatic multiple myeloma and are eligible for a stem cell transplant. They should be able to understand French and agree to participate fully in the study. Throughout the study, participants can expect to have four visits over two years to check for complications and receive care based on their specific needs. This trial aims to improve patient care and outcomes for those undergoing treatment for multiple myeloma.

Gender

ALL

Eligibility criteria

• 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 stringent 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), 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