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.

NCT ID: NCT05947136

Last Updated: 2024-02-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 204 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-19
• Study Completion Date: 2027-09-14

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.

Conditions

Multiple Myeloma; Complication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Intervention group

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.

Group Type: EXPERIMENTAL

Interpretation of the results from the detection visit

Intervention Type: 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

Intervention Type: 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.

Early medical care through the network

Intervention Type: BEHAVIORAL

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

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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.

Interventions

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;

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Early medical care through the network

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

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute, France

OTHER_GOV

Sponsor Role: collaborator

Centre Leon Berard

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mauricette MICHALLET, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Leon Berard

Locations

Centre Léon Bérard

Lyon, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Romain BUONO, PharmaD, MPH

Role: CONTACT

romain.buono@lyon.unicancer.fr

+33469856358

Meyssane DJEBALI, Msc

Role: CONTACT

meyssane.djebali@lyon.unicancer.fr

++33426556743

Facility Contacts

Mauricette MICHALLET, MD

Role: primary

mauricette.michallet@lyon.unicancer.fr

+3346998566358

Other Identifiers

PASCA-MM (ET22000285)

Identifier Type: -

Identifier Source: org_study_id