Daratumumab for the Treatment of Patients With AL Amyloidosis

Status Completed

Clinical Trial Summary

Participants with AL Amyloidosis will receive the drug daratumumab by IV infusion once weekly for two months, then every 2 weeks for four months, then once each month. Study treatment may continue until disease progression, unacceptable toxicity, or decision to withdraw from the trial. Disease evaluations will be performed every three months until disease progression.

Clinical Trial Description

This Phase I/II study is intended to evaluate the safety and tolerability of infusion of daratumumab in AL amyloidosis, specifically with respect to infusion reactions. In addition, the investigators would like to assess organ response with respect to cardiac biomarkers and proteinuria, as well as hematologic response and time to next treatment. Participants with AL Amyloidosis will receive the drug daratumumab by IV infusion once weekly for two months, then every 2 weeks for four months, then once each month. Study treatment may continue until disease progression, unacceptable toxicity, or decision to withdraw from the trial. Disease evaluations will be performed every three months until disease progression. ;

Study Design

Related Conditions & MeSH terms

AL Amyloidosis
Amyloidosis
Immunoglobulin Light-chain Amyloidosis

Clinical Trial Details

NCT number	NCT02841033
Study type	Interventional
Source	Boston Medical Center
Contact
Status	Completed
Phase	Phase 1/Phase 2
Start date	March 20, 2017
Completion date	July 17, 2020

View Details

See also
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