Velcade™ (bortezomib) combination chemotherapy in AL amyloidosis

Phase 2

Completed

• Conditions: Topic: National Cancer Research Network; Subtopic: Haematological Oncology; Disease: Leukaemia (acute), Leukaemia (acute lymphoblastic); Cancer; AL amyloidosis

• Registration Number: ISRCTN33283585
• Lead Sponsor: niversity College London (UCL) (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-07-30
• Study Completion: 2013-05-31
• Last Update Posted: 8 April 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

1. Aged 18 years or greater, either sex
2. Systemic AL amyloidosis who fulfil all the following criteria:
2.1. Measurable clonal disease in the serum as defined by either a serum paraprotein of greater than 7 g/L or the abnormal component of the serum free light chain greater than 75 mg/L (abnormal ratio only in case of renal failure)
2.2. Amyloid related organ dysfunction or organ syndrome
3. Following prior chemotherapy or prior autologous stem cell transplant, evidence of either:
3.1. Clonal disease relapse
3.2. Refractory clonal disease
3.3. Inadequate clonal response (defined as less than a 90% reduction in serum clonal markers)
4. Capable of providing written informed consent

Exclusion Criteria

1. Overt symptomatic non-amyloid manifestations of multiple myeloma
2. Amyloidosis of unknown or non-AL type
3. Localised AL amyloidosis (in which amyloid deposits are limited to a typical single organ, for example the bladder or larynx, in association with a clonal proliferative disorder within that organ)
4. Trivial or incidental AL amyloid deposits in the absence of a significant amyloid related organ syndrome (e.g., isolated carpal tunnel syndrome)
5. Allogeneic stem cell transplantation
6. Solid organ transplantation
7. Severe peripheral neuropathy or autonomic neuropathy causing significant functional impairment
8. Thrombocytopaenia (platelet count less than 50 x 10^9/l)
9. Neutropaenia (neutrophil count less than 1 x 10^9/l)
10. Liver involvement by amyloid causing bilirubin greater than 2 times or alkaline phosphatase greater than 4 times upper limit of normal
11. Estimated glomerular filtration rate (eGFR) less than 20 ml/min but not on dialysis (patients on dialysis are not excluded)
12. Ejection fraction less than 40%
13. New York Heart Association (NYHA) class IV heart failure
14. Eastern Cooperative Oncology Group (ECOG) performance status greater than 3
15. Estimated life expectancy of less than 3 months
16. Active hepatitis B or C or human immunodeficiency virus (HIV) infection
17. Previous cumulative anthracycline dose of greater than 200 mg/m2
18. Previous treatment with bortezomib combined with anthracycline and/or alkylator and/or immunomodulatory drugs (ImiD)
19. Concurrent active malignancies, except surgically removed basal cell carcinoma of the skin or other in situ carcinomas
20. Pregnant, lactating or unwilling to use adequate contraception
21. Intolerance/sensitivity to any of the study drugs

Study & Design

• Study Type: Interventional
• Study Design: Not specified