Isatuximab and Bendamustine in Systemic Light Chain Amyloidosis
Status:
Not yet recruiting
Trial end date:
2026-01-01
Target enrollment:
Participant gender:
Summary
Patients with systemic light chain (AL) amyloidosis, particularly those who are ineligible
for transplant or have relapsed/refractory disease, have limited treatment options. The
combination of bendamustine and dexamethasone is well-tolerated and efficacious in patients
with relapsed/refractory AL amyloidosis. Anti-CD38 antibodies have recently demonstrated
great efficacy in AL amyloidosis. Adding isatuximab, a monoclonal antibody targeting CD38, to
bendamustine would combine two mechanisms of targeting the clonal plasma cell without
significant overlap in toxicity. This would provide a steroid minimizing and neurotoxic-free
regimen for patients with AL amyloidosis. We propose a phase II clinical trial of isatuximab
and bendamustine in newly diagnosed or relapsed/refractory AL amyloidosis. We hypothesize
that this combination will result in a high number of deep hematologic responses.