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

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.

This study is testing if a special care program can help people with multiple myeloma have fewer complications during their stem cell transplant compared to standard care.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 204 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Centre Leon Berard (Academic / other)
• Locations: 1 site (Lyon)
• Trial ID: NCT05947136 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 70 with symptomatic multiple myeloma eligible for autologous hematopoietic stem cell transplantation.

Not a fit: Patients with a history of other primary cancers or those unable to participate due to medical or social reasons may not benefit from this study.

Why it matters

Potential benefit: If successful, this program could significantly reduce complications and improve the quality of care for multiple myeloma patients undergoing treatment.

How similar studies have performed: Other studies have shown promising results with proactive management approaches in similar patient populations, indicating potential for success in this trial.

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

Where this trial is running

Lyon

• Centre Léon Bérard — Lyon, France (Recruiting)

Study contacts

• Principal investigator: Mauricette MICHALLET, PhD, MD — Centre Leon Berard
• Study coordinator: Romain BUONO, PharmaD, MPH

Conditions Multiple Myeloma; Complication; Complications; Detection; Intervention; Autologous stem cell transplant; Randomized controlled trials