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.
- Conditions
- To evaluate the efficacy and safety of the combination treatment melpharan, dexamethasone and bortezomib (BMD treatment) for relapsed or refractory systemic AL amyloidosis.
- Registration Number
- JPRN-UMIN000006604
- Lead Sponsor
- Japan Community Health care Organization Kyoto kuramaguchi Medical Center, Department of Hematology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 21
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Hematological response rate post 6 months treatment
- Secondary Outcome Measures
Name Time Method Maximum tolerant dose, Organ response rate post 6 months treatment, Plasma free light chain level change from baseline, Average progression free survival, Average overall survival, Adverse event rate