Systemic AL amyloidosis MedDRA version: 14.1 Level: PT Classification code 10002022 Term: Amyloidosis System Organ Class: 10021428 - Immune system disorders
Conditions
Interventions
Trade Name: Velcade
Product Name: bortezomib
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: bortezomib
CAS Number: 179324-69-7
Current Sponsor code: bortezomib
Concentrat
Sponsors
University College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1 - Aged 18 years or greater. 2 - Systemic AL amyloidosis who fulfil all the following criteria: (i) Measurable clonal disease in the serum as defined by either a serum paraprotein of >7g/L or the abnormal component of the serum free light chain >75mg/L or dFLC >50 mg/L(only dFLC in case of renal failure), (ii) Amyloid related organ dysfunction or organ syndrome, (iii) Untreated Mayo Stage II or III patients 3- Capable of providing written, informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: a. Overt symptomatic non-amyloid manifestations of multiple myeloma b. Amyloidosis of unknown or non AL type c. 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) d. Trivial or incidental AL amyloid deposits in the absence of a significant amyloid related organ syndrome (e.g., isolated carpal tunnel syndrome) e. Allogeneic stem cell transplantation f. Solid organ transplantation g. Severe peripheral neuropathy or autonomic neuropathy causing significant functional impairment. h. Thrombocytopenia (platelet count 2 times or alkaline uthorized >4 times upper limit of normal k. eGFR 3 o. Estimated life expectancy of less than 3 months p. Concurrent active malignancies, except surgically removed basal cell carcinoma of the skin or other in situ carcinomas q. Pregnant, lactating or unwilling to use adequate contraception r. Intolerance / sensitivity to any of the study drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The REVEAL Trial aims to assess the efficacy, safety and tolerability of two bortezomib-based combination chemotherapy regimens: VD (bortezomib [Velcade], and dexamethasone) and CVD (cyclophosphamide, bortezomib [Velcade] and dexamethasone) in a randomized parallel phase II design in patients with AL amyloidosis who have Mayo stage II or III disease.;Secondary Objective: Primary objectives: 1. Clonal response to VD and CVD 2. safety and tolerability of VD and CVD The secondary research questions are to assess the following: 1. Amyloidotic organ response 2. Overall Survival 3. Relapse free survival ;Primary end point(s): 1. Clonal response of the underlying plasma cell dyscrasia to VD and to CVD. 2. Safety and toxicity of VD and CVD. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Improvement in amyloidotic organ function 2. Overall Survival 3. Relapse free surviva | — |
Countries
United Kingdom
Contacts
Public ContactREVEAL Trial Coordinator
CR UK & UCL Cancer Trials Centre
Outcome results
None listed