Phase 2
Completed N=70
Open-Label Phase 1/2 Study of VELCADE for Injection in Patients With Light-chain (AL)-Amyloidosis
Amyloidosis
Source: ClinicalTrials.gov NCT00298766 ↗
Enrolled (actual)
70
Serious AEs
35.7%
Results posted
Aug 2010
Primary outcomePrimary: Maximum Tolerated Dose — 2 participants with DLT
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.
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 | — |
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. Informational only — not medical advice.