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

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.

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