To evaluate the efficacy and safety of the combination treatment melpharan, dexamethasone and bortezomib (BMD treatment) for relapsed or refractory systemic AL amyloidosis.
Conditions
Interventions
Patients receive oral melphalan 8 mg/m2 on days 1-4, bortezomib SC (IV) on days 1, 4, 8 and 11, and dexamethasone orally on days 1-2, 4-5 8-9 11 and 12. Treatment repeats every 4 weeks (28 days) for u
Sponsors
Japan Community Health care Organization Kyoto kuramaguchi Medical Center, Department of Hematology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Confirmed diagnosis of AL amyloidosis 2)20 to 65 years old 3)Previously treated (within 3 courses of chemotherapy) 4)Transplant ineligible 5)Meeting all of the following *Serum creatinine =< 2 mg/dL *Serum ALT and AST =< 2.5 times upper limit of normal *Serum AlP =< 3 times upper limit of normal *Serum direct bilirubin =<2 mg/dL *WBC >= 3000/micro L (neutrophi count>=/micro L) *Platelet count >= 75000/micro L *HB >=8g/dL 6)No chronic disease (respiratory, neurological disease, or severe diabetes mellitus) that may disturb therapy. 7)No carriers of hepatitis virus, HTLVI virus or HIV virus
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hematological response rate post 6 months treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactChihiro Shimazaki
Japan Community Health care Organization Kyoyo kuramaguchi Medical Center Department of Hematology
Outcome results
None listed