High Dose Therapy Followed by Autologous Transplantation for Myeloma Patients With Severe Renal Impairment

Multiple Myeloma Clinical Trial

— IRMYG  

Official title:

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 (IRMYG Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03234335
• Other study ID #: 2017-0702
• Secondary ID: 2017-A02180-53
• Status: Completed
• Start date: April 10, 2018
• Est. completion date: September 27, 2022

Study information

• Verified date: May 2023
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 27, 2022
• Est. primary completion date: September 29, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 66 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Patient without at least a partial hematological response following the induction 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

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell
• Renal Failure
• Renal Insufficiency

Intervention

Other:
• Data collection
Myeloma patients with severe renal impairment who are susceptible to undergo autologous transplantation will be followed in this study, and data related to the pathology, treatments and transplantation will be reported.

Locations

Country	Name	City	State
Algeria	Centre Pierre et Marie Curie	Alger
Algeria	EHU Oran	Oran
Belgium	CHU Sart Tilman	Liège
France	Centre Hospitalier Universitaire d'Amiens	Amiens
France	Centre Hospitalier Universitaire d'Angers	Angers
France	Centre Hospitalier d'Argenteuil	Argenteuil
France	Centre Hospitalier de la Côte Basque	Bayonne
France	Centre Hospitalier Universitaire de Besançon	Besançon
France	Centre Hospitalier de Boulogne	Boulogne
France	CHU de Brest	Brest
France	Centre Hospitalier Universitaire de Caen	Caen
France	Centre Hospitalier de Cholet	Cholet
France	Centre Hospitalier Universitaire de Clermont Ferrand	Clermont-Ferrand
France	Centre Hospitalier Universitaire de Dijon	Dijon
France	Centre Hospitalier Universitaire de Grenoble	Grenoble
France	CHU de Limoges	Limoges
France	Centre Léon Bérard	Lyon
France	Hôpital Saint-Eloi	Montpellier
France	Centre Hospitalier Universitaire de Nancy	Nancy
France	Hôpital Archet	Nice
France	Groupe Hospitalier Pitié-Salpétrière	Paris
France	Hôpital Cochin	Paris
France	Hôpital Saint-Antoine	Paris
France	Hôpital Tenon	Paris
France	Institut Curie	Paris
France	Centre Hospitalier Lyon Sud	Pierre-Bénite
France	Hôpital Saint-Bernard	Poitiers
France	CHU de Rennes	Rennes
France	Hôpital Victor Provo (Roubaix)	Roubaix
France	CHU de Saint-Etienne	Saint-Priest-en-Jarez
France	Centre Hospitalier de Saint Quentin	Saint-Quentin
France	Hôpitaux Universitaires de Strasbourg	Strasbourg
Lebanon	American University of Beirut	Beyrouth

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne	Institut de Cancérologie de la Loire

Countries where clinical trial is conducted

Algeria,  Belgium,  France,  Lebanon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Non Relapse Mortality post-transplantation	Non-relapse mortality at Day +100 post-transplantation will be reported.	100 days post-transplantation
Secondary	Overall survival	Overall survival at 2 years post-transplantation will be reported.	2 years post-transplantation
Secondary	progression-free survival	progression-free survival at 2 years post-transplantation will be reported.	2 years post-transplantation
Secondary	Number of toxicities	Number of hematological and extra-hematological toxicities linked to autologous stem cell transplantation will be reported during 2 years.	2 years post-transplantation
Secondary	presence of hematological response	The presence of hematological response at Day+100 and at 6 months post-transplantation will be reported.	6 months
Secondary	Level of renal response	Level of renal response at 3 months, 6 months and one year post-transplantation will be quantified and reported.	3 months, 6 months and one year