A Pilot study of Response to Velcade combination chemotherapy in AL amyloidosis (REVEAL) - REVEAL

• Register: EUCTR
• Last refreshed on: 4 August 2015
• Main ID: EUCTR2009-014906-33-GB
• Date of registration: 18/06/2010
• Prospective Registration: Yes
• Primary sponsor: University College London
• Public title: A Pilot study of Response to Velcade combination chemotherapy in AL amyloidosis (REVEAL) - REVEAL
• Scientific title: A Pilot study of Response to Velcade combination chemotherapy in AL amyloidosis (REVEAL) - REVEAL
• Date of first enrolment: 17/09/2010
• Target sample size: 52
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-014906-33
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: Open: Single blind: Double blind: Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: Placebo: Other:

Countries of recruitment

United Kingdom

Contacts

• Name: REVEAL Trial Coordinator
• Affiliation: CR UK & UCL Cancer Trials Centre

• Name: REVEAL Trial Coordinator
• Affiliation: CR UK & UCL Cancer Trials Centre

Key inclusion & exclusion 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:
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 < 50x109/l)
i. Neutropenia (neutrophil count < 1x109/l)
j. Liver involvement by amyloid causing bilirubin >2 times or alkaline uthorized >4 times upper limit of normal
k. eGFR <20ml/min but not on dialysis (patients on dialysis are not excluded)
l. Significant ventricular arrhythmias
m. NYHA class IV heart failure
n. ECOG performance status >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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Systemic AL amyloidosis
MedDRA version: 14.1 Level: PT Classification code 10002022 Term: Amyloidosis System Organ Class: 10021428 - Immune system disorders

Therapeutic area: Diseases [C] - Cancer [C04]

Intervention(s)

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
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 3.5-

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
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 3.5-

Primary Outcome(s)

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.

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 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

Secondary Outcome(s)

Secondary end point(s): 1. Improvement in amyloidotic organ function
2. Overall Survival
3. Relapse free surviva

Secondary ID(s)

UCL/08/0254

Source(s) of Monetary Support

Cancer Research UK