drugset / Trial / NCT01728259

First-line Pomalidomide, Bortezomib, and Dexamethasone For AL Amyloidosis or LCDD

NCT01728259 ↗

Phase 1 Terminated 18 enrolled Barbara Ann Karmanos Cancer Institute
NaSingle-groupOpen-labelTreatment

Summary

This phase I trial studies the side effects and best dose of pomalidomide and bortezomib when given together with dexamethasone in treating patients with amyloid light-chain amyloidosis or light chain deposition disease. Biological therapies, such as pomalidomide, may stimulate the immune system in different ways and stop abnormal cells from growing. Bortezomib may stop the growth of abnormal cells by blocking some of the enzymes needed for cell growth. Giving pomalidomide and bortezomib together with dexamethasone may be an effective treatment for amyloid light-chain amyloidosis or light chain deposition disease

Timeline

Start
2013-03
Primary completion
2018-10-31
Completion
2018-10-31

Outcome

Outcome not reported

Stopped: “FDA placed the study on a clinical hold, due to the concerns by the FDA and Health Canada, Celgene decided to permanently close the study.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Bortezomib Small molecule — Intravenous
Subject Pomalidomide Other / unclassified — Oral
Background Dexamethasone Small molecule — Oral