Completed

An Open-Label Phase 1/2 Study of VELCADE for Injection in Subjects With Light-Chain (AL)-Amyloidosis

What is being tested

VELCADE

Drug

Who is being recruted

Amyloidosis+1

+ Metabolic Diseases

+ Nutritional and Metabolic Diseases

Over 18 Years

+8 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 1 & 2

Interventional

Study Start: June 2005

See protocol details

Summary

Principal SponsorMillennium Pharmaceuticals, Inc.

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2005

Actual date on which the first participant was enrolled.

This is a phase 1/2 open-label, dose-escalation study investigating single-agent therapy with VELCADE in patients with previously treated systemic AL-amyloidosis who require further treatment.

Official TitleAn Open-Label Phase 1/2 Study of VELCADE for Injection in Subjects With Light-Chain (AL)-Amyloidosis

NCT00298766

Principal SponsorMillennium Pharmaceuticals, Inc.

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

70 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AmyloidosisMetabolic DiseasesNutritional and Metabolic DiseasesProteostasis Deficiencies

Criteria

4 inclusion criteria required to participate

Male or Female 18 y/o and older

Female patients must be practicing an effective method of birth control

Biopsy-proven AL-amyloidosis

Must have been previously treated (failed at least 1 previous treatment) and in the opinion of the physician, patient requires further treatment

4 exclusion criteria prevent from participating

Hypersensitivity to boron or mannitol

Prior treatment with VELCADE

Patient requires other concomitant chemotherapy, radiotherapy or ancillary therapy considered investigational

Uncontrolled infection

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

VELCADE

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 4 locations

Suspended

Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute

Los Angeles, United StatesOpen Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute in Google Maps

Suspended

Winship Cancer Center - Emory Clinic School of Medicine

Atlanta, United States

Suspended

Boston Medical Center

Boston, United States

Suspended

MSKCC

New York, United States

Completed4 Study Centers