An observational study in Multiple Myeloma and Renal Failure, sponsored by Centre Hospitalier Universitaire de Saint Etienne. Completed at 33 sites in 4 countries. Open to participants aged 66 Years and older. Per ClinicalTrials.gov, last updated 2023-05-06.
Sponsored by Centre Hospitalier Universitaire de Saint Etienne · Observational
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.
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.
Myeloma patients with severe renal impairment suseptible of undergoing autologous transplantation.
Exclusion Criteria:
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
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.
Non Relapse Mortality post-transplantation
Non-relapse mortality at Day +100 post-transplantation will be reported.
Time frame: 100 days post-transplantation
Overall survival
Overall survival at 2 years post-transplantation will be reported.
Time frame: 2 years post-transplantation
progression-free survival
progression-free survival at 2 years post-transplantation will be reported.
Time frame: 2 years post-transplantation
Number of toxicities
Number of hematological and extra-hematological toxicities linked to autologous stem cell transplantation will be reported during 2 years.
Time frame: 2 years post-transplantation
presence of hematological response
The presence of hematological response at Day+100 and at 6 months post-transplantation will be reported.
Time frame: 6 months
Level of renal response
Level of renal response at 3 months, 6 months and one year post-transplantation will be quantified and reported.
Time frame: 3 months, 6 months and one year
This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier Universitaire de Saint Etienne