Open-Label Phase 1/2 Study of VELCADE for Injection in Patients With Light-chain (AL)-Amyloidosis
- Registration Number
- NCT00298766
- Lead Sponsor
- Millennium Pharmaceuticals, Inc.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 70
- 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
- Hypersensitivity to boron or mannitol
- Prior treatment with VELCADE
- Patient requires other concomitant chemotherapy, radiotherapy or ancillary therapy considered investigational
- Uncontrolled infection
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 VELCADE VELCADE
- Primary Outcome Measures
Name Time Method Maximum Tolerated Dose 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.Subjects With Treatment Emergent Adverse Events from first study-related procedure to 30 days after last dose of study medication Treatment emergent adverse events observed during outcome measure time frame
Subjects With Serious Treatment Emergent Adverse Events 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
Subjects Grade 3/4/5 Treatment Emergent Adverse Events 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.Subjects With Treatment Emergent Adverse Events Leading to Treatment Termination 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 Outcome Measures
Name Time Method Best Confirmed Hematologic Responders 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.
Trial Locations
- Locations (4)
Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute
🇺🇸Los Angeles, California, United States
Boston Medical Center
🇺🇸Boston, Massachusetts, United States
MSKCC
🇺🇸New York, New York, United States
Winship Cancer Center - Emory Clinic School of Medicine
🇺🇸Atlanta, Georgia, United States