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

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.
ClinicalTrials.gov Identifier: NCT00298766
Recruitment Status : Completed
First Posted : March 3, 2006
Results First Posted : August 13, 2010
Last Update Posted : June 25, 2012
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Amyloidosis Drug: VELCADE Phase 1 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
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
Study Start Date : June 2005
Primary Completion Date : July 2009
Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Amyloidosis
Drug Information available for: Bortezomib
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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.


  2. 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

  3. 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

  4. 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.


  5. 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 :
  1. 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.


Eligibility Criteria

Information from the National Library of Medicine

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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 Posted: March 3, 2006    Key Record Dates
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