Etude : IRMYG /



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Acronyme
Nom
Traitement
Type d'étude
MÀJ
Présentation de l'étude
Acronyme : IRMYG

Nom :

Traitement :

Type d'étude : Qualité de vie / Observationnelle

Dernière MÀJ : 23/10/2019
Titre
Spécialité(s)
CIM10 - Localisation(s)
Informations principales
Titre : A Prospective, Non-interventional, Multinational Study Evaluating the Efficacy and the Safety of High Dose Therapy Followed by Autologous Hematopoietic Stem Cell Transplantation as a Frontline Therapy for Myeloma Patients With Severe Renal Impairment

Spécialité : Tissus lymphoïde, hématopoïétique et apparentés
Localisation : C90 - Myélome multiple et tumeurs malignes à plasmocytes
Schéma
Phase
Stade
Ligne(s)
Informations complémentaires
Schéma : Multiple myeloma (MM) is a malignant plasma cell disorder, characterized by the presence of more than 10 % of clonal plasma cells in the bone marrow. Therapeutic intervention is recommended when at least one of the myeloma defining events occurs (CRAB features). Renal impairment (RI) is one of the most common complications of MM, accounting for 20-30 % of MM patients at diagnosis and 40-50% of patients during the course of their disease. To date, there is no defined consensus for the management of myeloma patients with renal failure. It is then of clinical importance to better considering available therapeutic options to improve responses and survival of these patients.

RI is associated with poor prognosis and short median survival (32 months vs 55 months for MM patients with normal renal function). Thus, RI remains a major challenge for hematologists, including decisions on optimal anti-myeloma therapy, potential dialysis, supportive care and quality of life. The combination of a proteasome inhibitor and an immunomodulator is the preferred induction treatment for newly diagnosed transplant-eligible MM patients. After induction, high-dose therapy with Autologous Stem Cell Transplant (ASCT) is the standard of care for these patients. However, concerns related to management of comorbidities and treatment side effects question about therapeutic options for patients with severe renal damage. Of interest, recent studies argued that high-dose therapy followed by ASCT could be a feasible and safe method for renal failure MM patients. Yet, these observations on small sample size patients groups need to be confirmed with standardized conditions. This study proposes to evaluate the efficacy and the safety of this therapeutic strategy in MM patients with severe renal impairment.

Phase : NA

Stade : NA

NA
Informations libres de droit
Critères d'inclusion
Critères de non-inclusion
Informations libres de droit
Critères d'inclusion et de non-inclusion
Critères d'inclusion : • Age ≤ 66 years-old
• Patients with symptomatic, measurable and newly diagnosed multiple myeloma associated:
• Severe renal failure at the time of transplantation (creatinine clearance < 40 ml/min/1.73m², CKD-EPI: Chronic Kidney Disease Epidemiology Collaboration)
• Partial response after induction treatment
• For patients who undergo autologous transplantation, absence of known contraindication for transplantation
• Absence of amylose
• Patient affiliated to a social security regimen or beneficiary of the same
• Signed written informed consent form

Critères de non-inclusion : stage
• Medical history of previous malignancy
• Patient under guardianship or deprived of his liberty or any condition that may affect the patient's ability to understand and sign the informed consent (art. L.1121-6, L.112-7, L.1211-8, L.1211-9)
• Pregnant or breastfeeding woman
• Declining participation
NCT
Promoteur
Coordonnateur
Informations relatives au promoteur
NCT :
NCT03234335
Promoteur :
Institut de Cancérologie de la Loire
Type de sponsor : Institutionnel
Lucien Neuwirth - 108 bis Avenue Albert Raimond
42270 ST PRIEST EN JAREZ

Coordonnateur :
Institut de Cancérologie de la Loire
Centre investigateur
Investigateur
TEC / ARC / IDE
État
MÀJ
Informations relatives aux investigateurs
Centre investigateur :
Centre Hospitalier de Roubaix - 11 Boulevard Lacordaire - 59100 ROUBAIX

Investigateur :
Docteur Isabelle DERVITE

TEC / ARC / IDE :
Camille TROUILLET
camille.trouillet@
ch-roubaix.fr
+33 3 20 99 31 31 | DECT 17 047 | POSTE 6907

Ouverture de l'essai : OUVERT

MAJ : 23/10/2019