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

Amyloidosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00298766
• Other study ID #: 26866138-CAN-2007
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: March 1, 2006
• Last updated: June 19, 2012
• Start date: June 2005
• Est. completion date: September 2009

Study information

• Verified date: June 2012
• Source: Millennium Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: September 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Amyloidosis

Intervention

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

Locations

Country	Name	City	State
United States	Winship Cancer Center - Emory Clinic School of Medicine	Atlanta	Georgia
United States	Boston Medical Center	Boston	Massachusetts
United States	Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute	Los Angeles	California
United States	MSKCC	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Millennium Pharmaceuticals, Inc.	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Tolerated Dose	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.	5 weeks in once weekly (QW) dose cohorts and 3 weeks in twice weekly (BIW) dose cohorts	Yes
Primary	Subjects With Treatment Emergent Adverse Events	Treatment emergent adverse events observed during outcome measure time frame	from first study-related procedure to 30 days after last dose of study medication	Yes
Primary	Subjects With Serious Treatment Emergent Adverse Events	Serious treatment emergent adverse events observed during outcome measure time frame	from first study-related procedure to 30 days after last dose of study medication	Yes
Primary	Subjects Grade 3/4/5 Treatment Emergent Adverse Events	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.	from first study-related procedure to 30 days after last dose of study medication	Yes
Primary	Subjects With Treatment Emergent Adverse Events Leading to Treatment Termination	Treatment emergent adverse events observed during outcome measure time frame leading to treatment termination	from first study-related procedure to 30 days after last dose of study medication	Yes
Secondary	Best Confirmed Hematologic Responders	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.	from first dose of study medication to end of study visit	No