World Health Organization site
Skip Navigation Links

Main
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: 5 June 2018
Main ID:  EUCTR2010-021445-42-BE
Date of registration: 10/10/2011
Prospective Registration: Yes
Primary sponsor: HOVON Foundation
Public title: A study in which is investigated if the medicine bortezomib is effective in patietns with AL amylodosis.
Scientific title: A multicenter, randomized phase II study of bortezomib and dexamethasone as induction treatment followed by high dose melphalan (HDM) and autologous stem cell transplantation (SCT) in patients with de novo amyloid light chain (AL) amyloidosis. - HOVON 104 AL amyloidosis
Date of first enrolment: 10/05/2012
Target sample size: 50
Recruitment status: Authorised-recruitment may be ongoing or finished
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-021445-42
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: no
Randomised: no
Open: yes
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: no
Number of treatment arms in the trial: 1
 
Phase:  Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no
Countries of recruitment
Belgium Germany Netherlands
Contacts
Name: HOVON Data Center   
Address:  ´s Gravendijkwal 230 3015 CE Rotterdam Netherlands
Telephone: +31107041560
Email: hdc@erasmusmc.nl
Affiliation:  Erasmus MC
Name: HOVON Data Center   
Address:  ´s Gravendijkwal 230 3015 CE Rotterdam Netherlands
Telephone: +31107041560
Email: hdc@erasmusmc.nl
Affiliation:  Erasmus MC
Key inclusion & exclusion criteria
Inclusion criteria:
• Biopsy proven, systemic, untreated AL amyloidosis requiring systemic chemotherapy,
• Age 18 -70 years inclusive at the time of signing the informed consent form,
• Measurable plasma cell dyscrasia, defined as a detectable M-protein with serum electrophoresis and/or level of involved FLC> 50 mg/L,
• Life expectancy > 3 months,
• WHO performance status 0-2,
• NYHA 1-2,
• Negative pregnancy test at inclusion for women of childbearing potential,
• 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 44
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6

Exclusion criteria:
• Multiple Myeloma stage II and III (Durie and Salmon),
• Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form,
• Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule,
• Previous treatment for plasma cell dyscrasia
• Pregnant or breast feeding females.
• Presence of other active malignancy or a history of active malignancy during the past 5 years, with the exception of nonmelanoma skin cancer, stage 0 cervical carcinoma, or treated early-stage prostate cancer provided that prostate-specific antigen is within normal limits,
• Hypersensitivity to boron or mannitol,
• Uncontrolled infection,
• Symptomatic othostatic hypotension defined as a decrease in systolic blood pressure on standing of >20mmHg combined with symptoms like dizziness, cerebral and/or cardial ischemia,
• Symptomatic effusions, defined as pleural effusion or ascites needing drainage therapy,
•NT pro BNP level > 5000 pg/ml and troponin T>0.06 microgram/L (not high sensitivity assay) or NT proBNP level>5000 pg/ml and Troponin I > 2 times ULN.
- Positive for HIV or infectious hepatitis, B or C,
• Bilirubin > 2x upper limit of normal,
• Creatinin clearance < 30 ml/min (after rehydration),
• Absolute neutrophil count < 1.0 × 109/L,
• NCI CTCAE grade peripheral sensory neuropathy > grade 2,
• NCI CTCAE grade peripheral sensory neuropathy > grade 1 in the presence of neuropathic pain,
• NCI CTCAE grade peripheral motor neuropathy > grade 2
• Concurrent diagnosis of B-cel NHL or B-CLL,
• Previous organ transplantation.
• Unwilling or unable to use adeaquate contraception




Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
AL Amyloidosis
MedDRA version: 20.0 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
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: BORTEZOMIB
CAS Number: 179324-69-7
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 3.5-

Primary Outcome(s)
Main Objective: To determine the efficacy of bortezomib plus dexamethasone followed by HDM and auto-SCT in patients with newly diagnosed AL amyloidosis who are 18-70 years inclusive.
Primary end point(s): • Hematological CR rate 6 months after auto-SCT.
Patients are considered a success if they received HDM and auto-SCT and are in CHR at 6 months, all other patients are considered a failure.
Secondary Objective: To asses the safety of bortezomib plus dexamethasone in the induction regimen followed by HDM and auto-SCT in patients with newly diagnosed AL amyloidosis who are 18-70 years inclusive.
Timepoint(s) of evaluation of this end point: About 10 months after inclusion of last patient
Secondary Outcome(s)
Secondary end point(s): • OS
• PFS
• Hematological response rate after induction therapy
• Response rate, hematological and organ
• Time to response, hematological and organ
• Duration of hematological and organ response
• Time to next AL amyloidosis therapy
• Safety (type, frequency, and severity of adverse events (AE) and relationship of AE to study drug)
• Exploratory assessment of multiparameter flow cytometry quantification of bone marrow plasma cells and change in amyloid depostition in abdominal fat aspiration samples
• Evaluation of prognostic factors for survival included in te hematological and organ response criteria
Timepoint(s) of evaluation of this end point: About 10 months after inclusion of last patient. May be repeated at later analysis.
Secondary ID(s)
2010-021445-42-NL
HO104
Source(s) of Monetary Support
Janssens Pharma NV
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.
Copyright - World Health Organization - Version 3.6 - Version history