Status:
COMPLETED
High Dose Therapy Followed by Autologous Transplantation for Myeloma Patients With Severe Renal Impairment
Lead Sponsor:
Centre Hospitalier Universitaire de Saint Etienne
Collaborating Sponsors:
Institut de Cancérologie de la Loire
Conditions:
Multiple Myeloma
Renal Failure
Eligibility:
All Genders
66+ years
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 le...
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 deci...
Eligibility Criteria
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
Exclusion
- 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
Key Trial Info
Start Date :
April 10 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 27 2022
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03234335
Start Date
April 10 2018
End Date
September 27 2022
Last Update
May 6 2023
Active Locations (33)
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1
Centre Pierre et Marie Curie
Algiers, Algeria
2
EHU Oran
Oran, Algeria
3
CHU Sart Tilman
Liège, Belgium
4
Centre Hospitalier Universitaire d'Amiens
Amiens, France