Ignite Creation Date:
2024-05-06 @ 7:15 PM
Last Modification Date:
2024-10-26 @ 3:03 PM
Study NCT ID:
NCT05947136
Status:
RECRUITING
Last Update Posted:
2024-02-21
First Post:
2023-07-07
Brief Title:
PASCA-MM Study Impact of the PASCA PArcours de Santé au Cours du CAncer Program on Complications Associated With Multiple Myeloma andor Its Treatments in the Context of a First Hematopoietic Stem Cell Autograft in Adults Aged 18 to 70
Sponsor:
Centre Leon Berard
Organization:
Centre Leon Berard
Study Overview
Official Title:
PASCA-MM Study Impact of the PASCA PArcours de Santé au Cours du CAncer Program on Complications Associated With Multiple Myeloma andor Its Treatments in the Context of a First Hematopoietic Stem Cell Autograft in Adults Aged 18 to 70
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PASCA -MM
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 11
Each patient will be allocated to one of the two groups described below by randomisation ratio 11
- 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 No1 T1 1-2 months after the autologous haematopoietic stem cell transplantation aHSCT corresponding to the patients visit to his or her Multiple Myeloma MM monitoring consultation andor the start of his or her consolidation treatment
Visit No2 T2 4 months after aHSCT corresponding to a patients visit for the end of consolidation treatment
Visit No3 T3 14 months after the last aHSCT corresponding to a visit by the patient during his or her maintenance treatment
Visit No4 T4 24 months after the last aHSCT corresponding to a visit by the patient for a MM monitoring consultation
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 11
Each patient will be allocated to one of the two groups described below by randomisation ratio 11
- 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 No1 T1 1-2 months after the autologous haematopoietic stem cell transplantation aHSCT corresponding to the patients visit to his or her Multiple Myeloma MM monitoring consultation andor the start of his or her consolidation treatment
Visit No2 T2 4 months after aHSCT corresponding to a patients visit for the end of consolidation treatment
Visit No3 T3 14 months after the last aHSCT corresponding to a visit by the patient during his or her maintenance treatment
Visit No4 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 treecomplication 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
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 treecomplication 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None