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.

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 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

• Multiple Myeloma
• Complication

Interventions

BEHAVIORAL

Interpretation of the results from the detection visit

\- An interpretation of the results of the detection tests concerning * the 7 complications of interest assessed at T1, T2, T3 and T4 ; * the 13 secondary complications assessed at T1, T3 and T4. This interpretation will be based on decision trees (1 tree/complication) to guide investigators in their decision-making and to standardise orientations;

BEHAVIORAL

Explaining detection results and referrals to the patient

Explanation of results and directions to the patient using plain language;The aims of this call are as follows: * Clearly explain the results of the detection visit and the action to be taken for each referral; * Evaluate the help to be given to the patient. This help will consist of making bookings with a healthcare professional in the PASCA network; * Reassure patients about their results, but also make them aware of the importance of taking action to improve or prevent the onset of complications.

BEHAVIORAL

Early medical care through the network

Early, proactive medical care through a network of dedicated healthcare professionals.

BEHAVIORAL

Transmission of results from each detection visit to the referring onco-haematologists - Control Group

For both the 7 complications of interest (primary objective) and the 13 secondary complications (secondary objective): all the data from each detection visit will be sent to the referring onco-haematologists, so that they can initiate their own management.

Sponsors & Collaborators

• National Cancer Institute, France

  collaborator OTHER_GOV

• Centre Leon Berard

  lead OTHER

Principal Investigators

• Mauricette MICHALLET, PhD, MD · Centre Leon Berard

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-01-19

Primary Completion

2027-06-14

Completion

2027-09-14

Countries

• France

Study Locations