Actively Recruiting
PASCA-MM Study on the Impact of the PASCA Program on Complications Associated with Multiple Myeloma and First Hematopoietic Stem Cell Transplant in Adults Aged 18 to 70
Led by Centre Leon Berard · Updated on 2026-04-30
204
Participants Needed
1
Research Sites
13 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
Researchers are evaluating the PASCA (PArcours de Santé au Cours du Cancer) program to study its impact on complications related to Multiple Myeloma and its treatments in adults aged 18 to 70 who have undergone a first autologous hematopoietic stem cell transplantation (aHSCT). This phase III, prospective, multicenter, randomized controlled trial compares two groups to assess both 7 primary complications and 13 secondary complications associated with the disease and treatment. The study aims to improve early detection and management of these complications to benefit patient care. Participants are randomly assigned to either the PASCA interventional group or the control group. The interventional group receives a specific and proactive referral system based on risk assessment from decision trees after each screening visit, supported by a dedicated network of healthcare professionals to initiate early treatment and follow-up. The control group has their screening data sent to their referring onco-hematologists, who then manage care independently. Screening assessments occur at four visits: 1-2 months, 4 months, 14 months, and 24 months after aHSCT. Throughout the study, participants undergo evaluations for the 7 primary and 13 secondary complications at scheduled visits post-transplant and during consolidation and maintenance treatments. These include monitoring for high blood pressure, kidney failure, chronic pain, sexual disorders, osteoporosis, fatigue, anxiety, and other health issues. Researchers collect data and provide explanations and referrals, with ongoing follow-up via phone calls and care coordination. The study measures changes in complication incidence over time, with safety and health outcomes tracked up to 24 months or longer for some complications.
CONDITIONS
Brief 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 18 to 70 years old
- Patient treated in an investigation center
- Diagnosed with symptomatic multiple myeloma eligible for autologous hematopoietic stem cell transplantation
- In stringent complete response, complete response, very good complete response, or partial response before transplantation
- Undergoing first induction treatment and related therapies including immunomodulator maintenance
- WHO ECOG performance status 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, socially, geographically, or psychologically for the study duration
- Deprived of liberty by court or administrative decision
- Not affiliated with a health insurance plan
- No declared attending physician
- Not domiciled in the Auvergne-Rhône-Alpes region or Saône-et-Loire department
- Not willing or available to participate for the entire study duration
- Pregnant or breastfeeding women
- People in emergency situations or unable to give personal consent, including adults under guardianship
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 months
Participants undergo detection visits where results for complications related to multiple myeloma and its treatments are assessed. For those in the intervention group, results are interpreted using decision trees, explained via phone calls, and early, proactive care is provided by a dedicated network of healthcare professionals. For the control group, detection results are sent to referring onco-hematologists for management.
Visits at month 2, month 4, month 14, and month 24
Trial Site Locations
Total: 1 location
1
Centre Léon Bérard
Lyon, France, 69373
Actively Recruiting
Research Team
R
Romain BUONO, PharmaD, MPH
M
Meyssane DJEBALI, Msc
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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