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

May 4, 2023 updated by: Centre Hospitalier Universitaire de Saint Etienne

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Algeria
      • Alger, Algeria
        • Centre Pierre et Marie Curie
      • Oran, Algeria
        • EHU Oran
  • Belgium
      • Liège, Belgium
        • CHU Sart Tilman
  • France
      • Amiens, France
        • Centre Hospitalier Universitaire d'Amiens
      • Angers, France, 49933
        • Centre hospitalier universitaire d'Angers
      • Argenteuil, France, 95100
        • Centre Hospitalier d'Argenteuil
      • Bayonne, France
        • Centre Hospitalier de la Côte Basque
      • Besançon, France
        • Centre Hospitalier Universitaire de Besançon
      • Boulogne, France
        • Centre Hospitalier de Boulogne
      • Brest, France
        • CHU de Brest
      • Caen, France, 14 000
        • Centre Hospitalier Universitaire de Caen
      • Cholet, France
        • Centre Hospitalier de Cholet
      • Clermont-Ferrand, France
        • Centre Hospitalier Universitaire de Clermont Ferrand
      • Dijon, France, 21 079
        • Centre Hospitalier Universitaire de Dijon
      • Grenoble, France, 38 043
        • Centre Hospitalier Universitaire de Grenoble
      • Limoges, France
        • CHU de Limoges
      • Lyon, France, 69 373
        • Centre Leon Berard
      • Montpellier, France, 34 295
        • Hôpital Saint-Eloi
      • Nancy, France, 54 500
        • Centre Hospitalier Universitaire de Nancy
      • Nice, France
        • Hôpital Archet
      • Paris, France
        • Hopital Cochin
      • Paris, France, 75 005
        • Institut Curie
      • Paris, France, 75 013
        • Groupe Hospitalier Pitie-Salpetriere
      • Paris, France, 75 020
        • Hopital Saint-Antoine
      • Paris, France, 75 020
        • Hôpital Tenon
      • Pierre-Bénite, France, 69 495
        • Centre Hospitalier Lyon Sud
      • Poitiers, France, 86 021
        • Hôpital Saint-Bernard
      • Rennes, France
        • CHU de Rennes
      • Roubaix, France
        • Hôpital Victor Provo (Roubaix)
      • Saint-Priest-en-Jarez, France, 42 270
        • Chu de Saint-Etienne
      • Saint-Quentin, France
        • Centre Hospitalier de Saint Quentin
      • Strasbourg, France
        • Hôpitaux Universitaires de Strasbourg
  • Lebanon
      • Beyrouth, Lebanon
        • American University of Beirut

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

66 years and older (Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Myeloma patients with severe renal impairment suseptible of undergoing autologous transplantation.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Myeloma patients with severe renal impairment
Myeloma patients with severe renal impairment. Data collection will concern myeloma patients with severe renal impairment who are susceptible to undergo autologous transplantation.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Non Relapse Mortality post-transplantation
Time Frame: 100 days post-transplantation
Non-relapse mortality at Day +100 post-transplantation will be reported.
100 days post-transplantation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 2 years post-transplantation
Overall survival at 2 years post-transplantation will be reported.
2 years post-transplantation
progression-free survival
Time Frame: 2 years post-transplantation
progression-free survival at 2 years post-transplantation will be reported.
2 years post-transplantation
Number of toxicities
Time Frame: 2 years post-transplantation
Number of hematological and extra-hematological toxicities linked to autologous stem cell transplantation will be reported during 2 years.
2 years post-transplantation
presence of hematological response
Time Frame: 6 months
The presence of hematological response at Day+100 and at 6 months post-transplantation will be reported.
6 months
Level of renal response
Time Frame: 3 months, 6 months and one year
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Collaborators

Institut de Cancérologie de la Loire

Investigators

  • Principal Investigator: Jérôme Cornillon, MD, Chu de Saint-Etienne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 10, 2018

Primary Completion (Actual)

September 29, 2020

Study Completion (Actual)

September 27, 2022

Study Registration Dates

First Submitted

July 26, 2017

First Submitted That Met QC Criteria

July 26, 2017

First Posted (Actual)

July 31, 2017

Study Record Updates

Last Update Posted (Estimate)

May 5, 2023

Last Update Submitted That Met QC Criteria

May 4, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-0702
  • 2017-A02180-53 (Other Identifier: ANSM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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