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OpenTrials
Completed

NCT Number: NCT00298766

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

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.

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Key information

Conditions

Amyloidosis Metabolic Diseases Nutritional and Metabolic Diseases Proteostasis Deficiencies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute, Los Angeles, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Hypersensitivity to boron or mannitol
  • Prior treatment with VELCADE
  • Patient requires other concomitant chemotherapy, radiotherapy or ancillary therapy considered investigational
  • Uncontrolled infection

Treatment and study plan

Velcade

Drug

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 names: Bortezomib

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Millennium Pharmaceuticals, Inc.

Industry

Collaborators

  • Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2009
Study completion
2009
First posted
Mar 3, 2006
Registry last updated
Jun 25, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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