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.
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.
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.
Parallel
Interpretation of the results from the detection visit
Behavioral\- 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;
Explaining detection results and referrals to the patient
BehavioralExplanation 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.
Early medical care through the network
BehavioralEarly, proactive medical care through a network of dedicated healthcare professionals.
Transmission of results from each detection visit to the referring onco-haematologists - Control Group
BehavioralFor 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.
change from Baseline high blood pressure
blood pressure ≥ 140/90 mmHg measured in the investigating center and persisting over time
Change from Baseline chronic kidney failure incidence at 24 months
diagnosed on the basis of 2 blood tests carried out within 3 months with the same technique showing either: * a decrease in GFR to \< 60ml/min/1.73m2, estimated from serum creatinine using the CKD-EPI equation (Chronic Kidney Disease EPIdemiology collaboration, Levey, 2009), * positive proteinuria or albuminuria (albuminuria/creatinine ratio), * haematuria with a GR \> 10/mm3 or 10,000/ml (after eliminating a urological cause), * leucocyturia with a WBC \>10/mm3 or 10,000/ml (in the absence of infection), * a morphological abnormality on renal ultrasound: size asymmetry, bumpy contours, small kidneys or large polycystic kidneys, nephrocalcinosis, cyst. The evolutionary character corresponds to one of the following situations: * Annual decline in GFR ≥ 5 ml/min/1.73 m²/year: GFR year n - GFR year n+1 * Presence of albuminuria, * Poorly controlled arterial hypertension
Change from Baseline chronic pain incidence at 60 months
pain felt for more than 3 months by the patient with an intensity on the Visual Analogue Scale (VAS) ≥ 3
Change from Baseline sexual disorders incidence at 24 months
at least one perceived problem among the following: * disorders of desire, * arousal/erection disorders in men, * arousal disorders (insufficiency) in women, * Orgasm disorders in women
Change from Baseline depressive events incidence at 24 months
Defined by at least two main depressive symptoms, associated with at least two symptoms additional information, according to the 2017 HAS recommendation "Characterized depressive episode in adults : care in first resort".
Change from Baseline physical deconditioning incidence at 24 months
Defined by at least two tests among the 6 min Walk Test (TDM6), Handgrip-test, 60s Sit-to-stand, Flamingo test, with usual values below the norms defined by their authors, according to age and sex
Change from Baseline cognitive problems incidence at 24 months
Positive score on at least one of the sub-dimensions of the Functional questionnaire Cancer Therapy Assessment - Cognitive Function (FACT-COG)
Change from Baseline hypogonadism incidence at 24 months
Presence of clinical signs as defined by the International Society for Sexual Medicine A value below the lower limit on at least one of the following blood assay: * level of total testosterone * level of bioavailable testosterone
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Centre Leon Berard
Lead sponsor
National Cancer Institute, France
Collaborator
