None listed
Conditions
Interventions
IV Melphalan will be dosed according to a risk-adapted schedule. Those who can safely receive high-dose IV Melphalan (=Transplant candidates) must have minimal cardiac disease (BNP<300, BP >90, no CCF/arrhythmias, O2 sats >94%, EF >40%), age < 65, ECOG performance status < 2, organs involved < 2 and bilirubin < 30mmol/L). Patients unsuitable for high-dose Melphalan (Non-transplant candidates) will receive intermediate-dose IV Melphalan and dexamethasone.Transplant candidates:Peripheral blood ste
IV Melphalan will be dosed according to a risk-adapted schedule. Those who can safely receive high-dose IV Melphalan (=Transplant candidates) must have minimal cardiac disease (BNP<300, BP >90, no CCF/arrhythmias, O2 sats >94%, EF >40%), age < 65, ECOG performance status < 2, organs involved < 2 and bilirubin < 30mmol/L). Patients unsuitable for high-dose Melphalan (Non-transplant candidates) will receive intermediate-dose IV Melphalan and dexamethasone.Transplant candidates:Peripheral blood stem cell collection with filgrastim alone (10µg/kg)Autologous stem cell transplantation with melphalan (140mg/m2 if CrCl < 50 mls/min or age > 60 yrs or ECOG performance status=2, otherwise 200mg/m2). Non-transplant candidates:Melphalan 20mg/m2 iv + dexamethasone 40mg d1-4 every 4 weeks for 2 cycles beyond free light chain plateau
Sponsors
Australasian Leukaemia and Lymphoma Group
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Confirmed diagnosis of AL amyloidosis (must have biopsy-proven amyloidosis and identification of a monoclonal light chain in the serum, urine or in a bone marrow where a monoclonal light chain is identified by immunohistochemical staining or flow cytometry). Positive immunohistochemistry of amyloid deposits or exclusion of hereditary mutations is required if there is uncertainty as to the type of amyloid. 2. Evidence of cardiac, renal, liver or neurologic involvement or other symptomatic organ involvement (asymptomatic gastrointestinal or marrow involvement alone are not indications for study inclusion). 3. ECOG performance status 0 to 3 inclusive. 4. Written informed consent prior to study registration.
Exclusion criteria
1. Clinically overt multiple myeloma with > 30% plasma cells in the bone marrow or the presence of lytic bone lesions or hypercalaemia2. B-cell lymphoproliferative disease3. Prior intravenous melphalan4. Therapy to reduce plasma cell dyscrasia within the previous four weeksNote: Prior stem cell mobilisation with G-CSF is not an exclusion criteria5. Absolute neutrophil count < 1.5 x 109 /L and platelet count < 100 x 109/L6. Concurrent or previous malignancy except adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix or other solid tumors treated for cure with no evidence of disease for at least 2 years7. Known HIV positivity8. Likely inability of the patient to comply with treatment assessments9. Pregnancy and lactation. Adults of reproductive potential must agree to use an effective method of birth control during treatment and for at least 3 months thereafter.
Outcome results
None listed