Neoplasms

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

For both the 7 complications of interest (primary objective) and the 13 secondary complications (secondary objective), specific and proactive referrals will be made systematically after each detection visit according to the level of risk, estimated on the basis of decision trees (management guide) and via the dedicated PASCA network of healthcare professionals, to initiate early treatment and follow-up where necessary.

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 forwarded to the referring onco-haematologists, so that they can initiate their own management.

- 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;

Interpretation of the results from the detection visit

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.

Explaining detection results and referrals to the patient

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

Early medical care through the network

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.

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

Romain BUONO, PharmaD, MPH

Meyssane DJEBALI, Msc

Mauricette MICHALLET, MD

Amine BELHABRI

Anne-Sophie MICHALLET

Philippe REY

Mauricette MICHALLET, PhD, MD

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.

After each screening visit, all patients randomised to the intervention group will receive the PASCA intervention:

1. An interpretation of the results of the screening 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;
2. Explanation of results and referrals to the patient using plain language, by a phone call, ;
3. Early, proactive care via a dedicated network of healthcare professionals.

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.

blood pressure ≥ 140/90 mmHg measured in the investigating center and persisting over time

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

pain felt for more than 3 months by the patient with an intensity on the Visual Analogue Scale (VAS) ≥ 3

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

T-score evaluated by osteodensitometry, on the lumbar spine and upper end of the femur

Questionnaire "MFI-20" (Multidimensional Fatigue Inventory)

Questionnaire "HADS-D" (Hospital Anxiety and Depression scale)

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".

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

Positive score on at least one of the sub-dimensions of the Functional questionnaire Cancer Therapy Assessment - Cognitive Function (FACT-COG)

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

BMI value:

* \[25-30\[ kg/m2 with a waist circumference above the norm (≥ 94cm for men or

  ≥ 80cm for women)
* ≥ 30 kg/m2

* level of thyroid-stimulating hormone
* level of total thyroxine

hypercholesterolemia (LDL) ≥ 1.6 g/L estimated by the Friedewald formula and/or a hypertriglyceridemia ≥ 4 g/L

NT-proBNP and/or troponin I level above the threshold values.

equivocal electrocardiogram, interpreted by an experienced physician

FVC, FVC, FEV1, FEF25-75, FEF50, FEF25 (established by spirometric test) ≤ 80% of the predicted values (abacus on age, sex, height and origin ethnic)

consumption :

* smoking and/or active cannabis
* alcohols higher than the latest recommendations

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
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.	NCT05947136	Multiple Myelom... Complication	Interpretation ... Explaining dete... Early medical c... Transmission of...	18 Years - 70 Years	Centre Leon Berard
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.	NCT05947136	Multiple Myelom... Complication	Interpretation ... Explaining dete... Early medical c... Transmission of...	18 Years - 70 Years	Centre Leon Berard

Spots Global Cancer Trial Database for interpretation of the results from the detection visit