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NCT05947136Recruiting

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.

Source: ClinicalTrials.gov · Last updated 11 Jun 2026

Brief summary (registry, in English)

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) as well as for the 13 complications (secondary objective): all the data from each identification check-up will be sent to the onco-haematological transmitted to the referring onco-haematologists, so that they can initiate their own management. =\> For all patients, regardless of group All patients will receive four screening assessments covering the 7 complications of interest and 13 secondary complications: * Visit No.1 (T1), 1-2 months after the autologous haematopoietic stem cell transplantation (aHSCT), corresponding to the patient's visit to his or her Multiple Myeloma (MM) monitoring consultation and/or the start of his or her consolidation treatment. * Visit No.2 (T2), 4 months after aHSCT, corresponding to a patient's visit for the end of consolidation treatment; * Visit No.3 (T3), 14 months after the last aHSCT, corresponding to a visit by the patient during his or her maintenance treatment; * Visit No.4 (T4), 24 months after the last aHSCT, corresponding to a visit by the patient for a MM monitoring consultation.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
204 (estimated)
First submitted
7 Jul 2023
Start date
19 Jan 2024
Primary completion date
14 Jun 2028
Lead sponsor
Centre Leon Berard
NCT number
NCT05947136

What you commit to

  • Study type: Interventional
  • Planned participants: 204
  • From 19 Jan 2024 to the primary completion date, 14 Jun 2028
  • 6 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • Unable to be monitored for medical, social, family, geographical or psychological, throughout the duration of the study.
  • Deprived of liberty by court or administrative decision.
  • Not affiliated with a health insurance plan.
  • Not having declared an attending physician.
  • Not domiciled in the Auvergne-Rhône-Alpes region or in the Saône-et-Loire department.
  • Not available and/or not willing to participate in the project for the entire duration of the study.
  • Pregnant women, breastfeeding women, people in emergency situations, people incapable of personally giving their consent including adults under guardianship

Who the study is looking for

  • Age ≥ 18 years old and ≤ 70 years old.
  • Patient treated in an investigation center.
  • Symptomatic multiple myeloma eligible for autologous hematopoietic stem cell transplantation (HSCT).
  • In complete response, complete response, very good complete response, or partial before HSCT.
  • 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.
  • ECOG performance status WHO ≤ 2.
  • No history or coexistence of other primary cancer apart from basal cell cancer cutaneous
  • Able to understand, read and write French.
  • Having signed and dated the informed consent.

Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (6)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
CH Annecy Genevois
Coordinator of this site? Confirm its status
ÉpagnyFranceRecruiting
CHU La Tronche
Coordinator of this site? Confirm its status
GrenobleFranceRecruiting
Centre Leon Berard
Coordinator of this site? Confirm its status
LyonFranceRecruiting
Centre Hospitalier Universitaire de Montpellier
Coordinator of this site? Confirm its status
MontpellierFranceRecruiting
CHU de St Etienne
Coordinator of this site? Confirm its status
Saint-EtienneFranceRecruiting
Le Centre Hôpitaux Nord-Ouest Villefranche-sur-Saône
Coordinator of this site? Confirm its status
Villefranche-sur-SaôneFranceRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.