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

Phase 1/Phase 2
18 Years
Not Enrolling

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Trial Information

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

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum Tolerated Dose

Outcome Description:

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.

Outcome Time Frame:

5 weeks in once weekly (QW) dose cohorts and 3 weeks in twice weekly (BIW) dose cohorts

Safety Issue:


Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Millennium Pharmaceuticals, Inc.


United States: Food and Drug Administration

Study ID:




Start Date:

June 2005

Completion Date:

September 2009

Related Keywords:

  • Amyloidosis
  • Amyloidosis



Boston Medical CenterBoston, Massachusetts  02118
Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer InstituteLos Angeles, California  90049
Winship Cancer Center - Emory Clinic School of MedicineAtlanta, Georgia  30322
MSKCCNew York, New York  10017