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A Safety Study of Carfilzomib in Patients With Previously-Treated Systemic Light Chain Amyloidosis

NCT01789242 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2017-10-18

No results posted yet for this study

Summary

This is a dose finding study to evaluate the safety and determine the maximum tolerated dose of carfilzomib in patients with previously treated systemic light-chain amyloidosis.

Conditions

  • Amyloidosis
  • Systemic Light Chain Amyloidosis

Interventions

DRUG

Carfilzomib

IV over 30 minutes on Days 1, 2, 8, 9, 15, and 16 every 28 days.

DRUG

Dexamethasone

Dexamethasone IV or PO on Days 1, 2, 8, 9, 15, and 16 every 28 days in patients with \<VGPR after 4 cycles.

Sponsors & Collaborators

  • Amgen

    collaborator INDUSTRY

  • Criterium, Inc.

    lead INDUSTRY

Principal Investigators

  • Adam Cohen, MD · AMyC; Univ of Penn Perelman Center for Advanced Medicine

  • Brian GM Durie, MD · AMyC

  • Raymond Comenzo, MD · AMyC, Tufts University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2016-12-31
Completion
2017-07-31

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01789242 on ClinicalTrials.gov