Phase 2
N=70
Open-Label Phase 1/2 Study of VELCADE for Injection in Patients With Light-chain (AL)-Amyloidosis
Amyloidosis
Bottom Line
View on ClinicalTrials.gov: NCT00298766 ↗Enrolled (actual)
70
Serious AEs
35.7%
Results posted
Aug 2010
Primary outcome: Primary: Maximum Tolerated Dose — 2 participants with DLT
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- VELCADE (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Millennium Pharmaceuticals, Inc.
- Primary completion
- Jul 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Tolerated Dose |
2 | — |
| PRIMARY Subjects With Treatment Emergent Adverse Events |
70 | — |
| PRIMARY Subjects With Serious Treatment Emergent Adverse Events |
25 | — |
| PRIMARY Subjects Grade 3/4/5 Treatment Emergent Adverse Events |
43 | — |
| PRIMARY Subjects With Treatment Emergent Adverse Events Leading to Treatment Termination |
23 | — |
| SECONDARY Best Confirmed Hematologic Responders |
33 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00298766). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.