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

Centre Hospitalier Universitaire de Saint Etienne

Status: Completed

Conditions: Renal Failure; Multiple Myeloma

Treatments: Other: Data collection

Study type: Observational

Funder types: Other

Identifiers

NCT03234335

2017-0702

2017-A02180-53 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 66+ years old

Volunteers: No Healthy Volunteers

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

Trial design

50 participants in 1 patient group

Myeloma patients with severe renal impairment

Description:

Myeloma patients with severe renal impairment. Data collection will concern myeloma patients with severe renal impairment who are susceptible to undergo autologous transplantation.

Treatment:

Other: Data collection