Clinical trial NCT05947136: 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.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Multiple Myeloma
Complication
Keywords: Multiple Myeloma
Complications
Detection
Intervention
Autologous stem cell transplant
Randomized controlled trials
Lead sponsor: Centre Leon Berard
Sponsor class: OTHER
Collaborators: name: National Cancer Institute, France
First posted: 2023-07-17
Enrollment: 204
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years old and ≤ 70 years old.
2. Patient treated in an investigation center.
3. Symptomatic multiple myeloma eligible for autologous hematopoietic stem cell transplantation (HSCT).
4. In stringent complete response, complete response, very good complete response, or partial before HSCT.
5. First induction-type treatment (Isa-KRD/dara-VRD/dara-VTD/VRD/VTD), intensification therapy with melphalan, HSCT, consolidation, maintenance including at least one drug immunomodulator.
6. ECOG performance status WHO ≤ 2.
7. No history or coexistence of other primary cancer apart from basal cell cancer cutaneous
8. Able to understand, read and write French.
9. Having signed and dated the informed consent.

Exclusion Criteria:

1. Unable to be monitored for medical, social, family, geographical or psychological, throughout the duration of the study.
2. Deprived of liberty by court or administrative decision.
3. Not affiliated with a health insurance plan.
4. Not having declared an attending physician.
5. Not domiciled in the Auvergne-Rhône-Alpes region or in the Saône-et-Loire department.
6. Not available and/or not willing to participate in the project for the entire duration of the study.
7. Pregnant women, breastfeeding women, people in emergency situations, people incapable of personally giving their consent including adults under guardianship

Primary outcomes:
measure: change from Baseline high blood pressure
timeFrame: month 2, month 4, month 14 and month 24
measure: Change from Baseline chronic kidney failure incidence at 24 months
timeFrame: month 2, month 4, month 14 and month 24
measure: Change from Baseline chronic pain incidence at 60 months
timeFrame: month 2, month 4, month 14 and month 24
measure: Change from Baseline sexual disorders incidence at 24 months
timeFrame: month 2, month 4, month 14 and month 24
measure: Change from Baseline osteoporosis incidence at 24 months
timeFrame: month 2, month 14 and month 24
measure: Change from Baseline chronic fatigue incidence at 24 months
timeFrame: month 2, month 4, month 14 and month 24
measure: Change from Baseline severe anxiety disorder incidence at 24 months
timeFrame: month 2, month 4, month 14 and month 24
Secondary outcomes:
measure: Change from Baseline depressive events incidence at 24 months
timeFrame: month 2, month 4, month 14 and month 24
measure: Change from Baseline physical deconditioning incidence at 24 months
timeFrame: month 2, month 14 and month 24
measure: Change from Baseline cognitive problems incidence at 24 months
timeFrame: month 2, month 14 and month 24
measure: Change from Baseline hypogonadism incidence at 24 months
timeFrame: month 2, month 14 and month 24
measure: Change from Baseline obesity incidence at 24 months
timeFrame: month 2, month 14 and month 24
measure: Change from Baseline hypothyroidism incidence at 24 months
timeFrame: month 2, month 14 and month 24
measure: Change from Baseline dyslipidemias incidence at 24 months
timeFrame: month 2, month 14 and month 24
measure: Change from Baseline Heart failure markers incidence at 24 months
timeFrame: month 2, month 14 and month 24
measure: Change from Baseline Atrial fibrillation incidence at 24 months
timeFrame: month 2, month 14 and month 24
measure: Change from Baseline of respiratory failure markers incidence at 24 months
timeFrame: month 2, month 14 and month 24
measure: Change from Baseline return to work issues incidence at 24 months
timeFrame: month 2, month 14 and month 24
measure: Change from Baseline of Lifestyle risk factors ( tobacco, alcohol, and cannabis) incidence at 24 months
timeFrame: month 2, month 4, month 14 and month 24
measure: Change from baseline Myelodysplastic syndromes and secondary acute leukemia incidence at 24 months
timeFrame: month 4, month 14 and month 24
Other outcomes:
Locations:
city: Lyon
country: France
facility: Centre Léon Bérard
Study officials:
affiliation: Centre Leon Berard
name: Mauricette MICHALLET, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References: