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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 16 August 2016
Main ID:  EUCTR2010-022395-31-DK
Date of registration: 09/06/2011
Prospective Registration: Yes
Primary sponsor: E.M.N. - EUROPEAN MYELOMA NETWORK
Public title: A randomized open-label multicenter phase III trial of Melphalan and Dexamethasone (MDex) versus Bortezomib, Melphalan and Dexamethasone (BMDex) for untreated patients with systemic light-chain (AL) amyloidosis
Scientific title: A randomized open-label multicenter phase III trial of Melphalan and Dexamethasone (MDex) versus Bortezomib, Melphalan and Dexamethasone (BMDex) for untreated patients with systemic light-chain (AL) amyloidosis
Date of first enrolment: 14/11/2011
Target sample size: 110
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-022395-31
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: Combination of IMPs Number of treatment arms in the trial: 2  
Phase:  Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no
Countries of recruitment
Czech Republic Denmark Germany Greece Italy Norway Spain Sweden
United Kingdom
Contacts
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Key inclusion & exclusion criteria
Inclusion criteria:
1. Histologic diagnosis of amyloidosis. 2. Genetic testing must be negative for transthyretin mutations associated with hereditary amyloidosis or immunohistochemistry of amyloid deposits must provide clear evidence of K or ? light chains in those who present with peripheral neuropathy or heart as the dominant organ involvement. 3. Not eligible for ASCT with melphalan 200 mg/m2 . Patients who are eligible for SCT with melphalan 200 mg/m2 but decline the procedure, can be enrolled in the study, but are stratified in a separate stratum before randomization. 4. Patients must be = 18 years of age. 5. ECOG performance status 0,1 or 2. 6. Measurable disease; al least one of the following criteria: • monoclonal protein >10 g/L in serum • amyloid-forming (involved) FLC >75 mg/L with an abnormal K/? ratio • difference between involved and uninvolved FLC >50 mg/L • bone marrow with a clonal predominance 7. Symptomatic organ involvement 8. Hemoglobin =11 g/dL, absolute neutrophil count =1500/mcL, platelets =140,000/mcL. 9. Total bilirubin <2.5 mg/dL, alkaline phosphatase <5 × u.l.n., ALT <3 × u.l.n.. 10. Estimated glomerular filtration rate (eGFR) by the MDRD formula >30 ml/min. 11. Only patients who are informed of the investigational nature of this study and sign and give written informed consent in accordance with institutional, national and European guidelines are eligible to participate. 12. Women must be either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control 13. Men must agree to use an acceptable method for contraception for the duration of the study.

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:
1. Amyloid-specific syndrome 2. Isolated soft tissue involvement. 3. Presence of non-AL amyloidosis. 4. Previous treatment for plasma cell disease. 5. Bone marrow plasma cells >30%. 6. Cardiac stage III disease: both cTnT > 0.035 ng/mL (or in place of cTnT the cTnI > 0.10 ng/mL) and simultaneous NT-proBNP >332 ng/L. 7. Repetitive ventricular arrhythmias on 24h Holter ECG in spite of anti-arrhythmic treatment or chronic atrial fibrillation 8. Supine systolic blood pressure <100 mmHg or symptomatic orthostatic hypotension or clinically important autonomic disease 9. Grade 3 sensory or grade 1 painful peripheral neuropathy. 10. Patients with AL who are eligible for ASCT with 200 mg/m2 of melphalan. These are patients <65 years of age, without cardiac involvement (determined according to the consensus criteria), with eGFR >51mL/min, left ventricular ejection fraction >45%, and bilirubin <2.0 mg/dL. 11. Pregnant or nursing women. 12. Clinically overt multiple myeloma with lytic bone lesions 13. Patients with uncontrolled infection or active malignancy with the exception of adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years. 14. Patients with medically documented cardiac syncope, uncompensated NYHA Class 3 or 4 congestive heart failure, or myocardial infarction within the previous 6 months are not eligible. 15. HIV positive. 16. Patients with serious medical or psychiatric illness likely to interfere with participation in this clinical study. 17. Patients with hypersensitivity to bortezomib, boron or mannitol.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
AL Amyloidosis
MedDRA version: 14.1 Level: HLGT Classification code 10035227 Term: Plasma cell neoplasms System Organ Class: 10005329 - Blood and lymphatic system disorders
Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Intervention(s)

Trade Name: VELCADE
Product Name: bortezomib
Pharmaceutical Form: Powder and solvent for solution for injection

Product Name: Dexamethasone
Pharmaceutical Form: Tablet

Trade Name: Alkeran
Product Name: Melphalan
Pharmaceutical Form: Film-coated tablet

Product Name: Dexamethasone
Pharmaceutical Form: Tablet

Product Name: Melphalan
Pharmaceutical Form: Film-coated tablet

Primary Outcome(s)
Main Objective: To compare the hematologic response after 3 cycles of therapy
Primary end point(s): Hematologic response after 3 cycles of therapy.
Secondary Objective: 1. Complete hematologic response rate after 3 cycles and after completion of therapy; 2. Hematologic response rate at completion of therapy; 3. Organ response rates at 3, 6, 9 and 12 months; 4. Treatment-related mortality; 5. Toxicity; 6. Overall and progression-free survival; 7. Time to hematologic and organ response; 8. Quality of life.
Secondary Outcome(s)
Secondary end point(s): To compare in patients treated with MDex or BMDex:
1)complete hematologic response rate after 3 cycles and after completion of therapy;
2)hematologic response rate at completion of therapy;
3)organ response rates at 3, 6, 9 and 12 months;
4)treatment-related mortality;
5)toxicity;
6)overall and progression-free survival;
7)time to hematologic and organ response;
8)quality of life.
Secondary ID(s)
2010-022395-31-IT
AC-004-EU
Source(s) of Monetary Support
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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