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

Millennium Pharmaceuticals

Status and phase: Completed; Phase 2; Phase 1

Conditions: Amyloidosis

Treatments: Drug: VELCADE

Study type: Interventional

Funder types: Industry

Identifiers

NCT00298766

26866138-CAN-2007

Details and patient eligibility

About

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.

Enrollment: 70 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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70 participants in 1 patient group

1

Experimental group

Description:

VELCADE

Treatment:

Drug: VELCADE