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.

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorCentre Leon Berard

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Interpretation of the results from the detection visit
  • Explaining detection results and referrals to the patient
  • Early medical care through the network
  • Transmission of results from each detection visit to the referring onco-haematologists - Control Group

Treatment groups

204 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Centre Leon Berard

Lead sponsor

National Cancer Institute, France

Collaborator