Isatuximab, Velcade, and Dexamethasone in Patients With Multiple Myeloma and Severe KIDNEY Disease
Status:
Not yet recruiting
Trial end date:
2030-04-30
Target enrollment:
Participant gender:
Summary
This is a phase Ib study to assess the safety, tolerability, preliminary efficacy, and renal
response of isatuximab, bortezomib, and dexamethasone in newly diagnosed multiple myeloma
patients with severe renal impairment or dialysis-dependent end-stage renal disease. Such
patients have limited therapeutic options due to renal clearance or nephrotoxicity of many
myeloma therapies and are often excluded from clinical trials. Isatuximab in other regimens
has shown efficacy and tolerability in patients with moderate renal impairment, although data
are lacking for regimens containing CD38-targeting immunotherapies in severe renal
impairment/ESRD.