Orthotopic heart transplantation followed by autologous stem cell transplantation in patients with cardiac AL amyloidosis - a Phase II study

Not Applicable

Recruiting

• Conditions: AL amyloidosis with cardiac involvement; Cancer - Myeloma; Cardiovascular - Other cardiovascular diseases

• Registration Number: ACTRN12617000215325
• Lead Sponsor: St Vincent's Hospital Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-02-09
• Last Update Posted: 26 October 2021

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1.Cardiac AL Amyloidosis, Stage III (a) or (b) prior to heart transplantation
2.received orthotopic heart transplantation
3.adequate cardiac function: Ejection fraction > 50%, no restrictive cardiomyopathy in echocardiogram or cardiac MRI
4.absence of cardiac rejection
5.no evidence of amyloid infiltration to the cardiac allograft
6.Measurable light chains prior to induction chemotherapy (FLC > 1.5xULN with abnormal kappa:lambda ratio)
7.MeasureableNT-ProBNPandTroponin-Tpriortoinduction chemotherapy
8.ECOG status of less than 2 or Karnofsky score less than 60 (see appendix B)
9.Able to provide informed consent

Exclusion Criteria

1.Amyloidosis other than AL Amyloidosis. This includes AA amyloidosis, senile amyloidosis, heritable amyloidosis (including but not limited to transerythin (ATTR) cardiac amyloidosis). Patients will require a negative genetic screen for heritable amyloidosis at Westmead Hospital Amyloid unit.
2.Diagnosis of multiple myeloma with more than 20% bone marrow plasma cells with end-organ involvement
3.Diagnosis of other haematological or solid organ malignancies
4.Other Amyloidosis-related end-organ diseases including renal disease (creatinine greater than 2x ULN), hepatic failure (AST, ALT greater than 3x ULN, Bilirubin > 2x ULN)
5.Significant cytopenias: Haemoglobin level <80g/L, neutrophil count <1x109/L, platelet count <75x109/L
6.Hepatitis B, C or HIV seropositivity
7.Pregnancy or breastfeeding
8.Patient with other serious medical or psychiatric illness likely to interfere with participation in this clinical study
9.Greater than grade 1 peripheral neuropathy
10.Smoking or intravenous drug use within 6 months of potential cardiac transplant

Study & Design

• Study Type: Interventional
• Study Design: Not specified