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.

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 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 stringent complete response, complete response, very good complete response, or partial before HSCT.

• 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.

• 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.

Locations
Other Locations
France
Centre Léon Bérard
RECRUITING
Lyon
Contact Information
Primary
Romain BUONO, PharmaD, MPH
romain.buono@lyon.unicancer.fr
+33469856358
Backup
Meyssane DJEBALI, Msc
meyssane.djebali@lyon.unicancer.fr
++33426556743
Time Frame
Start Date: 2024-01-19
Estimated Completion Date: 2027-09-14
Participants
Target number of participants: 204
Treatments
Experimental: 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.
Active_comparator: 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.
Related Therapeutic Areas
Sponsors
Leads: Centre Leon Berard
Collaborators: National Cancer Institute, France

This content was sourced from clinicaltrials.gov

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