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

NCT03234335 | Completed

• 2 other identifiers: 2017-07022017-A02180-53
• Study Type: observational
• Target: 50
• Locations: 4 countries
• Sites: 33

Brief 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.

Conditions

Multiple Myeloma; Renal Failure

Keywords

Multiple Myeloma; Renal Failure; Autologous Hematopoietic Stem Cell Transplantation (ASCT); Melphalan

Outcome Measures

Primary Outcomes (1)

• Non Relapse Mortality post-transplantation

  Non-relapse mortality at Day +100 post-transplantation will be reported.

  100 days post-transplantation

Secondary Outcomes (5)

• Overall survival

  2 years post-transplantation

• progression-free survival

  2 years post-transplantation

• Number of toxicities

  2 years post-transplantation

• presence of hematological response

  6 months

• Level of renal response

  3 months, 6 months and one year

Study Arms (1)

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

Interventions

Data collection OTHER

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.

Myeloma patients with severe renal impairment

Eligibility Criteria

• Age: 66 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead
• Institut de Cancérologie de la Loire: collaborator

Study Sites (33)

Centre Pierre et Marie Curie

Algiers, Algeria

Location

EHU Oran

Oran, Algeria

Location

CHU Sart Tilman

Liège, Belgium

Location

Centre Hospitalier Universitaire d'Amiens

Amiens, France

Location

Centre Hospitalier Universitaire d'Angers

Angers, 49933, France

Location

Centre Hospitalier d'Argenteuil

Argenteuil, 95100, France

Location

Centre Hospitalier de la Côte Basque

Bayonne, France

Location

Centre Hospitalier Universitaire de Besançon

Besançon, France

Location

Centre Hospitalier de Boulogne

Boulogne, France

Location

CHU de Brest

Brest, France

Location

Centre Hospitalier Universitaire de Caen

Caen, 14 000, France

Location

Centre Hospitalier de Cholet

Cholet, France

Location

Centre Hospitalier Universitaire de Clermont Ferrand

Clermont-Ferrand, France

Location

Centre Hospitalier Universitaire de Dijon

Dijon, 21 079, France

Location

Centre Hospitalier Universitaire de Grenoble

Grenoble, 38 043, France

Location

CHU de Limoges

Limoges, France

Location

Centre Léon Bérard

Lyon, 69 373, France

Location

Hôpital Saint-Eloi

Montpellier, 34 295, France

Location

Centre Hospitalier Universitaire de Nancy

Nancy, 54 500, France

Location

Hôpital Archet

Nice, France

Location

Institut Curie

Paris, 75 005, France

Location

Groupe Hospitalier Pitié-Salpétrière

Paris, 75 013, France

Location

Hôpital Saint-Antoine

Paris, 75 020, France

Location

Hôpital Tenon

Paris, 75 020, France

Location

Hôpital Cochin

Paris, France

Location

Centre Hospitalier Lyon Sud

Pierre-Bénite, 69 495, France

Location

Hôpital Saint-Bernard

Poitiers, 86 021, France

Location

CHU de Rennes

Rennes, France

Location

Hôpital Victor Provo (Roubaix)

Roubaix, France

Location

CHU de Saint-Etienne

Saint-Priest-en-Jarez, 42 270, France

Location

Centre Hospitalier de Saint Quentin

Saint-Quentin, France

Location

Hôpitaux Universitaires de Strasbourg

Strasbourg, France

Location

American University of Beirut

Beirut, Lebanon

Location

MeSH Terms

Conditions

Multiple Myeloma; Renal Insufficiency

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Jérôme Cornillon, MD

  CHU de Saint-Etienne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2017
• First Posted: July 31, 2017
• Study Start: April 10, 2018
• Primary Completion: September 29, 2020
• Study Completion: September 27, 2022
• Last Updated: May 6, 2023

Record last verified: 2023-05

Locations

FR (29); AL (2); LE (1); BE (1)