Multiple Myeloma Clinical Trial
— PASCA -MMOfficial 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.
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.
Status | Recruiting |
Enrollment | 204 |
Est. completion date | September 14, 2027 |
Est. primary completion date | June 14, 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | Centre Léon Bérard | Lyon |
Lead Sponsor | Collaborator |
---|---|
Centre Leon Berard | National Cancer Institute, France |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | change from Baseline high blood pressure | blood pressure = 140/90 mmHg measured in the investigating center and persisting over time | month 2, month 4, month 14 and month 24 | |
Primary | Change from Baseline chronic kidney failure incidence at 24 months | diagnosed on the basis of 2 blood tests carried out within 3 months with the same technique showing either:
a decrease in GFR to < 60ml/min/1.73m2, estimated from serum creatinine using the CKD-EPI equation (Chronic Kidney Disease EPIdemiology collaboration, Levey, 2009), positive proteinuria or albuminuria (albuminuria/creatinine ratio), haematuria with a GR > 10/mm3 or 10,000/ml (after eliminating a urological cause), leucocyturia with a WBC >10/mm3 or 10,000/ml (in the absence of infection), a morphological abnormality on renal ultrasound: size asymmetry, bumpy contours, small kidneys or large polycystic kidneys, nephrocalcinosis, cyst. The evolutionary character corresponds to one of the following situations: Annual decline in GFR = 5 ml/min/1.73 m²/year: GFR year n - GFR year n+1 Presence of albuminuria, Poorly controlled arterial hypertension |
month 2, month 4, month 14 and month 24 | |
Primary | Change from Baseline chronic pain incidence at 60 months | pain felt for more than 3 months by the patient with an intensity on the Visual Analogue Scale (VAS) = 3 | month 2, month 4, month 14 and month 24 | |
Primary | Change from Baseline sexual disorders incidence at 24 months | at least one perceived problem among the following:
disorders of desire, arousal/erection disorders in men, arousal disorders (insufficiency) in women, Orgasm disorders in women |
month 2, month 4, month 14 and month 24 | |
Primary | Change from Baseline osteoporosis incidence at 24 months | T-score evaluated by osteodensitometry, on the lumbar spine and upper end of the femur | month 2, month 14 and month 24 | |
Primary | Change from Baseline chronic fatigue incidence at 24 months | Questionnaire "MFI-20" (Multidimensional Fatigue Inventory) | month 2, month 4, month 14 and month 24 | |
Primary | Change from Baseline severe anxiety disorder incidence at 24 months | Questionnaire "HADS-D" (Hospital Anxiety and Depression scale) | month 2, month 4, month 14 and month 24 | |
Secondary | Change from Baseline depressive events incidence at 24 months | Defined by at least two main depressive symptoms, associated with at least two symptoms additional information, according to the 2017 HAS recommendation "Characterized depressive episode in adults
: care in first resort". |
month 2, month 4, month 14 and month 24 | |
Secondary | Change from Baseline physical deconditioning incidence at 24 months | Defined by at least two tests among the 6 min Walk Test (TDM6), Handgrip-test, 60s Sit-to-stand, Flamingo test, with usual values below the norms defined by their authors, according to age and sex | month 2, month 14 and month 24 | |
Secondary | Change from Baseline cognitive problems incidence at 24 months | Positive score on at least one of the sub-dimensions of the Functional questionnaire Cancer Therapy Assessment - Cognitive Function (FACT-COG) | month 2, month 14 and month 24 | |
Secondary | Change from Baseline hypogonadism incidence at 24 months | Presence of clinical signs as defined by the International Society for Sexual Medicine
A value below the lower limit on at least one of the following blood assay: level of total testosterone level of bioavailable testosterone |
month 2, month 14 and month 24 | |
Secondary | Change from Baseline obesity incidence at 24 months | BMI value:
[25-30[ kg/m2 with a waist circumference above the norm (= 94cm for men or = 80cm for women) = 30 kg/m2 |
month 2, month 14 and month 24 | |
Secondary | Change from Baseline hypothyroidism incidence at 24 months | level of thyroid-stimulating hormone
level of total thyroxine |
month 2, month 14 and month 24 | |
Secondary | Change from Baseline dyslipidemias incidence at 24 months | hypercholesterolemia (LDL) = 1.6 g/L estimated by the Friedewald formula and/or a hypertriglyceridemia = 4 g/L | month 2, month 14 and month 24 | |
Secondary | Change from Baseline Heart failure markers incidence at 24 months | NT-proBNP and/or troponin I level above the threshold values. | month 2, month 14 and month 24 | |
Secondary | Change from Baseline Atrial fibrillation incidence at 24 months | equivocal electrocardiogram, interpreted by an experienced physician | month 2, month 14 and month 24 | |
Secondary | Change from Baseline of respiratory failure markers incidence at 24 months | FVC, FVC, FEV1, FEF25-75, FEF50, FEF25 (established by spirometric test) = 80% of the predicted values (abacus on age, sex, height and origin ethnic) | month 2, month 14 and month 24 | |
Secondary | Change from Baseline return to work issues incidence at 24 months | Diagnosed by a social worker | month 2, month 14 and month 24 | |
Secondary | Change from Baseline of Lifestyle risk factors ( tobacco, alcohol, and cannabis) incidence at 24 months | consumption :
smoking and/or active cannabis alcohols higher than the latest recommendations |
month 2, month 4, month 14 and month 24 | |
Secondary | Change from baseline Myelodysplastic syndromes and secondary acute leukemia incidence at 24 months | confirmed by the reference diagnosis | month 4, month 14 and month 24 |
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