PASCA-MM Study. Impact of the PASCA (PArcours de Santé au Cours du CAncer) Program on Comp
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
| Condition(s) | Multiple Myeloma, Complication |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | 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 f |
| Who can participate | 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, fa |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Lead sponsor | Centre Leon Berard |
| Locations | Épagny, France; Grenoble, France; Lyon, France; Montpellier, France; Saint-Etienne, France; Villefranche-sur-Saône, France |
| Start date | 2024-01-19 |
| NCT ID | NCT05947136 |
| Official listing | https://clinicaltrials.gov/study/NCT05947136 |