Actively Recruiting
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.
Led by Centre Leon Berard · Updated on 2026-04-30
204
Participants Needed
1
Research Sites
190 weeks
Total Duration
On this page
Sponsors
C
Centre Leon Berard
Lead Sponsor
N
National Cancer Institute, France
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 70 years old
- Patient treated in an investigation center
- Symptomatic multiple myeloma eligible for autologous hematopoietic stem cell transplantation (HSCT)
- In stringent complete response, complete response, very good complete response, or partial response before HSCT
- First induction treatment with specified regimens, intensification with melphalan, HSCT, consolidation, and maintenance including at least one immunomodulatory drug
- ECOG performance status WHO 2 or less
- No history or coexistence of other primary cancer except basal cell skin cancer
- Able to understand, read, and write French
- Signed and dated informed consent
You will not qualify if you...
- Unable to be monitored medically or socially throughout the study
- Deprived of liberty by court or administrative decision
- Not affiliated with a health insurance plan
- No declared attending physician
- Not domiciled in the Auvergne-Rh�f4ne-Alpes region or Sa�ne-et-Loire department
- Not available or unwilling to participate for the entire study duration
- Pregnant or breastfeeding women
- People in emergency situations
- People unable to personally give consent, including adults under guardianship
AI-Screening
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Trial Site Locations
Total: 1 location
1
Centre Léon Bérard
Lyon, France, 69373
Actively Recruiting
Research Team
R
Romain BUONO, PharmaD, MPH
CONTACT
M
Meyssane DJEBALI, Msc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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