Multiple Myeloma, Renal Failure
Conditions
Keywords
Multiple Myeloma, Renal Failure, Autologous Hematopoietic Stem Cell Transplantation (ASCT), Melphalan
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.
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.
Interventions
OTHERData 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.
Sponsors
Institut de Cancérologie de la Loire
Centre Hospitalier Universitaire de Saint Etienne
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
66 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Non Relapse Mortality post-transplantation | 100 days post-transplantation | Non-relapse mortality at Day +100 post-transplantation will be reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 2 years post-transplantation | Overall survival at 2 years post-transplantation will be reported. |
| progression-free survival | 2 years post-transplantation | progression-free survival at 2 years post-transplantation will be reported. |
| Number of toxicities | 2 years post-transplantation | Number of hematological and extra-hematological toxicities linked to autologous stem cell transplantation will be reported during 2 years. |
| presence of hematological response | 6 months | The presence of hematological response at Day+100 and at 6 months post-transplantation will be reported. |
| Level of renal response | 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. |
Countries
Algeria, Belgium, France, Lebanon
Outcome results
None listed