This is an open-label, multicenter, Phase 2 study in subjects with newly diagnosed or previous treated systemic light chain (AL) amyloidosis. Approximately 40 subjects will receive therapy with bortezomib, pomalidomide, and dexamethasone. The primary outcome is hematologic very good partial response and complete response rate at 6 months.
Proteasome inhibitor and immunmodulators have synergistic effect for plasma cell dyscrasia. Due to the fact that more than 70-80% of patients with amyloidosis have renal involvement, the application of lenalidomide is limited. Thus, the investigators designed this open-label, multicenter, phase 2 study for newly diagnosed or previously treated systemic AL amyloidosis with bortezomib, pomalidomide and dexamethasone regimen.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Bortezomib 1.3mg/m2 sc weekly
4mg per day taken orally on 1-21 of repeated 28-day cycles
Dexamethasone 20mg-40mg weekly
Peking University People's Hospital
Beijing, Beijing Municipality, China
RECRUITINGHematologic VGPR + CR rate at 6 months
Hematologic very good partial response plus complete response rate at 6 months
Time frame: 6 months
Overall Hematologic response rate at 6 months
Overall Hematologic partial response, very good partial response rate and complete response at 6 months
Time frame: 6 months
At least one organ response at 6 months
At least one organ response (cardiac response, renal response, liver response) at 6 months
Time frame: 6 months
TTNT at 2 years
Time to next treatment at 2 years
Time frame: 2 years
Estimated PFS at 2 years
Estimated Progression free survival at 2 years
Time frame: 2 years
Estimated OS at 2 years
Estimated Overall Survival at 2 years
Time frame: 2 years
TRAE
Treatment-related adverse events up to 6 months
Time frame: 6 months
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