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Open-Label Phase 1/2 Study of VELCADE for Injection in Patients With Light-chain (AL)-Amyloidosis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00298766
First Posted: March 3, 2006
Last Update Posted: June 25, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by (Responsible Party):
Millennium Pharmaceuticals, Inc.
  Purpose
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.

Condition Intervention Phase
Amyloidosis Drug: VELCADE Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Phase 1/2 Study of VELCADE for Injection in Subjects With Light-Chain (AL)-Amyloidosis

Resource links provided by NLM:


Further study details as provided by Millennium Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Maximum Tolerated Dose [ Time Frame: 5 weeks in once weekly (QW) dose cohorts and 3 weeks in twice weekly (BIW) dose cohorts ]

    Maximum Tolerated Dose (MTD) was defined as the highest dose level that has 0/1 out of 6 patients experiences Dose Limited Toxicity (DLT). MTD is defined separately for QW and BIQ dose cohorts.

    DLT was defined as adverse events occurring during Cycle 1 and: (1) related to VELCADE, (2) Grade 4 thrombocytopenia or neutropenia, (3) Grade 3 or higher nonhematologic toxicity.


  • Subjects With Treatment Emergent Adverse Events [ Time Frame: from first study-related procedure to 30 days after last dose of study medication ]
    Treatment emergent adverse events observed during outcome measure time frame

  • Subjects With Serious Treatment Emergent Adverse Events [ Time Frame: from first study-related procedure to 30 days after last dose of study medication ]
    Serious treatment emergent adverse events observed during outcome measure time frame

  • Subjects Grade 3/4/5 Treatment Emergent Adverse Events [ Time Frame: from first study-related procedure to 30 days after last dose of study medication ]

    Grade 3/4/5 treatment emergent adverse events observed during outcome measure time frame.

    Grade is determined according to Common Terminology Criteria for Adverse Event (CTCAE) Version 3.0.


  • Subjects With Treatment Emergent Adverse Events Leading to Treatment Termination [ Time Frame: from first study-related procedure to 30 days after last dose of study medication ]
    Treatment emergent adverse events observed during outcome measure time frame leading to treatment termination


Secondary Outcome Measures:
  • Best Confirmed Hematologic Responders [ Time Frame: from first dose of study medication to end of study visit ]
    Hematologic response was determined by the investigator per the response criteria for immunoglobulin light chain amyloidosis by Gertz (2005). It include Complete and Partial Responders (CR+PR). CR requires serum and urine negative for a monoclonal protein by immunofixation and free light chain ratio normal. PR requires: 1. reduction in quantitative serum M-protein by 50% if baseline value is at least 0.5 g/dL, 2. if light chain is detected in the urine (with a consistent peak and >100 mg/ 24 hours), then 50% reduction is required, 3. if free light chain >10 mg/dL, reduction by 50% is required.


Enrollment: 70
Study Start Date: June 2005
Study Completion Date: September 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
VELCADE
Drug: VELCADE

Once weekly at: 0.7, 1.0, 1.3 or 1.6 mg/m2

Or

Twice-weekly at: 0.7, 1.0, or 1.3 mg/m2

Other Name: Bortezomib

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or Female 18 y/o and older
  2. Female patients must be practicing an effective method of birth control
  3. Biopsy-proven AL-amyloidosis
  4. Must have been previously treated (failed at least 1 previous treatment) and in the opinion of the physician, patient requires further treatment

Exclusion Criteria:

  1. Hypersensitivity to boron or mannitol
  2. Prior treatment with VELCADE
  3. Patient requires other concomitant chemotherapy, radiotherapy or ancillary therapy considered investigational
  4. Uncontrolled infection
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00298766


Locations
United States, California
Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute
Los Angeles, California, United States, 90049
United States, Georgia
Winship Cancer Center - Emory Clinic School of Medicine
Atlanta, Georgia, United States, 30322
United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
United States, New York
MSKCC
New York, New York, United States, 10017
Sponsors and Collaborators
Millennium Pharmaceuticals, Inc.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Investigators
Study Director: Medical Monitor Millennium Pharmaceuticals, Inc.
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00298766     History of Changes
Other Study ID Numbers: 26866138-CAN-2007
First Submitted: March 1, 2006
First Posted: March 3, 2006
Results First Submitted: July 16, 2010
Results First Posted: August 13, 2010
Last Update Posted: June 25, 2012
Last Verified: June 2012

Additional relevant MeSH terms:
Amyloidosis
Proteostasis Deficiencies
Metabolic Diseases
Bortezomib
Antineoplastic Agents