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.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 204
- 试验地点
- 7
- 主要终点
- Change from Baseline sexual disorders incidence at 24 months
研究概览
简要总结
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.
详细描述
After each screening visit, all patients randomised to the intervention group will receive the PASCA intervention:
- 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;
- Explanation of results and referrals to the patient using plain language, by a phone call, ;
- Early, proactive care via a dedicated network of healthcare professionals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 complete response, complete response, very good complete response, or partial before HSCT.
- •First induction-type treatment (Isa-KRD/dara-VRD/dara-VTD/VRD/VTD/dara-VRD), intensification therapy with melphalan, HSCT, consolidation, maintenance including at least one drug immunomodulator.
- •ECOG performance status WHO ≤
- •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.
排除标准
- •Unable to be monitored for medical, social, family, geographical or psychological, throughout the duration of the study.
- •Deprived of liberty by court or administrative decision.
- •Not affiliated with a health insurance plan.
- •Not having declared an attending physician.
- •Not domiciled in the Auvergne-Rhône-Alpes region or in the Saône-et-Loire department.
- •Not available and/or not willing to participate in the project for the entire duration of the study.
- •Pregnant women, breastfeeding women, people in emergency situations, people incapable of personally giving their consent including adults under guardianship
研究组 & 干预措施
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.
干预措施: Interpretation of the results from the detection visit (Behavioral)
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.
干预措施: Explaining detection results and referrals to the patient (Behavioral)
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.
干预措施: Early medical care through the network (Behavioral)
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.
干预措施: Transmission of results from each detection visit to the referring onco-haematologists - Control Group (Behavioral)
结局指标
主要结局
Change from Baseline sexual disorders incidence at 24 months
时间窗: month 2, month 4, month 14 and month 24
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
Change from Baseline chronic kidney failure incidence at 24 months
时间窗: month 2, month 4, month 14 and month 24
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
Change from Baseline chronic pain incidence at 60 months
时间窗: month 2, month 4, month 14 and month 24
pain felt for more than 3 months by the patient with an intensity on the Visual Analogue Scale (VAS) ≥ 3
change from Baseline high blood pressure
时间窗: month 2, month 4, month 14 and month 24
blood pressure ≥ 140/90 mmHg measured in the investigating center and persisting over time
Change from Baseline osteoporosis incidence at 24 months
时间窗: month 2, month 14 and month 24
T-score evaluated by osteodensitometry, on the lumbar spine and upper end of the femur
Change from Baseline chronic fatigue incidence at 24 months
时间窗: month 2, month 4, month 14 and month 24
Questionnaire "MFI-20" (Multidimensional Fatigue Inventory)
Change from Baseline severe anxiety disorder incidence at 24 months
时间窗: month 2, month 4, month 14 and month 24
Questionnaire "HADS-D" (Hospital Anxiety and Depression scale)
次要结局
- Change from Baseline depressive events incidence at 24 months(month 2, month 4, month 14 and month 24)
- Change from Baseline physical deconditioning incidence at 24 months(month 2, month 14 and month 24)
- Change from Baseline cognitive problems incidence at 24 months(month 2, month 14 and month 24)
- Change from Baseline obesity incidence at 24 months(month 2, month 14 and month 24)
- Change from Baseline dyslipidemias incidence at 24 months(month 2, month 14 and month 24)
- Change from Baseline of respiratory failure markers incidence at 24 months(month 2, month 14 and month 24)
- Change from Baseline of Lifestyle risk factors ( tobacco, alcohol, and cannabis) incidence at 24 months(month 2, month 4, month 14 and month 24)
- Change from Baseline Heart failure markers incidence at 24 months(month 2, month 14 and month 24)
- Change from Baseline return to work issues incidence at 24 months(month 2, month 14 and month 24)
- Change from Baseline hypogonadism incidence at 24 months(month 2, month 14 and month 24)
- Change from Baseline hypothyroidism incidence at 24 months(month 2, month 14 and month 24)
- Change from Baseline Atrial fibrillation incidence at 24 months(month 2, month 14 and month 24)
- Change from baseline Myelodysplastic syndromes and secondary acute leukemia incidence at 24 months(month 4, month 14 and month 24)