Isatuximab and Bendamustine in Systemic Light Chain Amyloidosis (NCT04943302) | Clinical Trial Compass
WithdrawnPhase 2
Isatuximab and Bendamustine in Systemic Light Chain Amyloidosis
Stopped: PI left institution. Study not moving forward in her absence.
0Started 2022-09-01
Plain-language 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. This study is a phase II clinical trial of isatuximab and bendamustine in newly diagnosed or relapsed/refractory AL amyloidosis. It is hypothesized that this combination will result in a high number of deep hematologic responses.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age ≥ 18
✓. Histopathologically confirmed AL amyloidosis based on detection by polarizing microscopy of green birefringent material in Congo Red stained tissue specimens or characteristic electron microscopy appearance or immunohistohemical stain with anti-light chain anti-sera. Diagnosis cannot be based solely on congo red stain on bone marrow biopsy.
✓. Measurable disease (one of the following):
✓. Serum monoclonal protein ≥ 0.5g/dL
✓. Urine monoclonal protein \>200mg/dL in 24 hour urine collection
✓. Clonal population of plasma cells in the bone marrow
✓. dFLC \> 40mg/L
✓. Mayo Cardiac Amyloid Stage I-IIIA based on the Mayo 2004/European Addition criteria
Exclusion criteria
✕. Resistant to prior anti CD38 antibody therapy as defined as either non-responsive or progression while on or within 60 days of discontinuation of treatment