Bortezomib, Pomalidomide, Dexamethasone for Systemic AL Amyloidosis

ConditionSystemic Amyloidosis

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18-90

SponsorJin Lu, MD

About this trial

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.

Eligibility criteria

Qualifiers

Diagnosis of AL amyloidosis, confirmed by histology and typed with immunohistochemistry, immunoelectron microscopy or mass spectrometry.

Newly diagnosed or previous treated AL amyloidosis

Patients must be ≥ 18 years of age.

ECOG performance status 0, 1 or 2.

Disqualifiers

Fulfill with the criteria of active multiple myeloma or active lymphoplasmacytic lymphoma.

Presence of other tumors which is/are in advanced malignant stage and has/have systemic metastasis;

Severe or persistent infection that cannot be effectively controlled;

Presence of severe autoimmune diseases or immunodeficiency disease;

Trial design

Treatments tested in this trial

Bortezomib
Pomalidomide
Dexamethasone

Treatment groups

40 Participants

are divided into 1 treatment group

Sponsors and collaborators

Jin Lu, MD

Lead sponsor

Peking University People's Hospital

Sponsor institution

Source ClinicalTrials.gov