Trial 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.
NCT ID:
NCT05947136
Condition:
Multiple Myeloma
Complication
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Conditions: Keywords:
Multiple Myeloma
Complications
Detection
Intervention
Autologous stem cell transplant
Randomized controlled trials
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Interpretation of the results from the detection visit
Description:
- 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;
Arm group label:
Intervention group
Intervention type:
Behavioral
Intervention name:
Explaining detection results and referrals to the patient
Description:
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.
Arm group label:
Intervention group
Intervention type:
Behavioral
Intervention name:
Early medical care through the network
Description:
Early, proactive medical care through a network of dedicated healthcare professionals.
Arm group label:
Intervention group
Intervention type:
Behavioral
Intervention name:
Transmission of results from each detection visit to the referring onco-haematologists - Control Group
Description:
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.
Arm group label:
Control group
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Centre Léon Bérard
Address:
City:
Lyon
Zip:
69373
Country:
France
Status:
Recruiting
Contact:
Last name:
Mauricette MICHALLET, MD
Phone:
+3346998566358
Email:
mauricette.michallet@lyon.unicancer.fr
Investigator:
Last name:
Amine BELHABRI
Email:
Sub-Investigator
Investigator:
Last name:
Anne-Sophie MICHALLET
Email:
Sub-Investigator
Investigator:
Last name:
Philippe REY
Email:
Sub-Investigator
Start date:
January 19, 2024
Completion date:
September 14, 2027
Lead sponsor:
Agency:
Centre Leon Berard
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute, France
Agency class:
Other
Source:
Centre Leon Berard
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05947136
