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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:
Collaborator:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by (Responsible Party):
Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00298766
First received: March 1, 2006
Last updated: June 19, 2012
Last verified: June 2012
History of Changes
  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: 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:

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

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 ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Millennium Pharmaceuticals, Inc.

Additional 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
Study First Received: March 1, 2006
Results First Received: July 16, 2010
Last Updated: June 19, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Amyloidosis
Proteostasis Deficiencies
Metabolic Diseases
Bortezomib
Antineoplastic Agents
 Therapeutic Uses
Pharmacologic Actions
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013