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 | Recruiting

• 1 other identifier: PASCA-MM (ET22000285)
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 6

Brief 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

Keywords

Multiple Myeloma; Complications; Detection; Intervention; Autologous stem cell transplant; Randomized controlled trials

Outcome Measures

Primary Outcomes (7)

• change from Baseline high blood pressure

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

  month 2, month 4, month 14 and month 24

• 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

  month 2, month 4, month 14 and month 24

• 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

  month 2, month 4, month 14 and month 24

• 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

  month 2, month 4, month 14 and month 24

• Change from Baseline osteoporosis incidence at 24 months

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

  month 2, month 14 and month 24

• Change from Baseline chronic fatigue incidence at 24 months

  Questionnaire "MFI-20" (Multidimensional Fatigue Inventory)

  month 2, month 4, month 14 and month 24

• Change from Baseline severe anxiety disorder incidence at 24 months

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

  month 2, month 4, month 14 and month 24

Secondary Outcomes (13)

• Change from Baseline depressive events incidence at 24 months

  month 2, month 4, month 14 and month 24

• Change from Baseline physical deconditioning incidence at 24 months

  month 2, month 14 and month 24

• Change from Baseline cognitive problems incidence at 24 months

  month 2, month 14 and month 24

• Change from Baseline hypogonadism incidence at 24 months

  month 2, month 14 and month 24

• Change from Baseline obesity incidence at 24 months

  month 2, month 14 and month 24

Study Arms (2)

Intervention group

EXPERIMENTAL

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.

Behavioral: Interpretation of the results from the detection visit; Behavioral: Explaining detection results and referrals to the patient; Behavioral: Early medical care through the network

Control group

ACTIVE COMPARATOR

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.

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

Interventions

Explaining detection results and referrals to the patient BEHAVIORAL

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.

Intervention group

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;

Intervention group

Early medical care through the network BEHAVIORAL

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

Intervention group

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

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.

Control group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• First induction-type treatment (Isa-KRD/dara-VRD/dara-VTD/VRD/VTD/dara-VRD), intensification therapy with melphalan, HSCT, consolidation, maintenance including at least one drug immunomodulator.
• ECOG performance status WHO ≤ 2.
• No history or coexistence of other primary cancer apart from basal cell cancer cutaneous
• Able to understand, read and write French.
• Having signed and dated the informed consent.

You may not qualify if:

• 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.
• Not domiciled in the Auvergne-Rhône-Alpes region or in the Saône-et-Loire department.
• Not available and/or not willing to participate in the project for the entire duration of the study.
• Pregnant women, breastfeeding women, people in emergency situations, people incapable of personally giving their consent including adults under guardianship

Sponsors & Collaborators

• Centre Leon Berard: lead
• National Cancer Institute, France: collaborator

Study Sites (6)

CH Annecy Genevois

Épagny, 74370, France

RECRUITING

CHU La Tronche

Grenoble, 38300, France

RECRUITING

Centre Léon Bérard

Lyon, 69373, France

RECRUITING

CENTRE HOSPITALIER UNIVERSITAIRE de MONTPELLIER

Montpellier, 34295, France

RECRUITING

CHU de St-Etienne

Saint-Etienne, France

RECRUITING

Le Centre Hôpitaux Nord-Ouest Villefranche-sur-Saône

Villefranche-sur-Saône, 69655, France

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Mauricette MICHALLET, PhD, MD

  Centre Leon Berard

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Romain BUONO, PharmaD, MPH

CONTACT

+33469856358; romain.buono@lyon.unicancer.fr

Meyssane DJEBALI, Msc

CONTACT

++33426556743; meyssane.djebali@lyon.unicancer.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2023
• First Posted: July 17, 2023
• Study Start: January 19, 2024
• Primary Completion (Estimated): June 14, 2028
• Study Completion (Estimated): September 14, 2029
• Last Updated: June 11, 2026

Record last verified: 2026-04

Locations

FR (6)