NCT02841033

Daratumumab for the Treatment of Patients With AL Amyloidosis

A Phase I-II Trial of Daratumumab for the Treatment of Patients With AL Amyloidosis

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Boston Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• AL Amyloidosis

Interventions

Type	Name	Description
DRUG	daratumumab	Daratumumab by IV infusion once weekly for two months, then every 2 weeks for four months, then once each month until progression or inability to tolerate.

Timeline

• Start date: 2017-03-20
• Primary completion: 2020-05-28
• Completion: 2020-07-17
• First posted: 2016-07-21
• Last updated: 2021-05-07
• Results posted: 2021-05-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study