JPRN-UMIN000006604
Completed
Phase 1
Phase I/II study to evaluate the efficacy and safety of the combination treatment of melpharan, dexamethasone and bortezomib for relapsed or refractory systemic AL amyloidosis. - BMD treatment for relapsed or refractory systemic AL amyloidosis.
Japan Community Health care Organization Kyoto kuramaguchi Medical Center, Department of Hematology0 sites21 target enrollmentOctober 24, 2011
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- To evaluate the efficacy and safety of the combination treatment melpharan, dexamethasone and bortezomib (BMD treatment) for relapsed or refractory systemic AL amyloidosis.
- Sponsor
- Japan Community Health care Organization Kyoto kuramaguchi Medical Center, Department of Hematology
- Enrollment
- 21
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •1\)Untreated patients 2\)History of botezomib exposure 3\)Poor\-risk patients (Skinner et al.Ann Intern Med140:85,2004\) i)Decompensated heart failure (NYHA\>\=3\) ii)Ejection fraction \< 0\.40 iii)Persistent pleural effusion iv)Systolic blood pressure \< 90 mmHg v)Oxygen saturation \< 95%,room air vi)Performance Status \>\= 3 4\)Neurological disorders (peripheral neuropathy, orthostatic hypotension, or paralytic ileus) excluding carpal tunnel syndrome 5\)Gastrointestinal symptoms 6\)NT\-proBNP \>\= 332 pg/mL (BNP \>\=50 pg/mL) 7\)A case with pulmonary complication (interstitial pneumonia, lung fibrosis, lung amyloidosis, etc.): Check abnormalities by evaluation by CT, utilize KL\-6, SP\-D, and SP\-A laboratory data auxiliary, and judge synthetically. 8\)Subject was pregnant or potential
Outcomes
Primary Outcomes
Not specified
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