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Clinical picture: MM (Multiple Myeloom)

Trial: HOVON 104 AL AMYLOIDOSIS


News
1. Overview
2. Patient eligibility criteria
3. Registration (& randomization) of patients
4. Participating parties
5. Participating sites
6. Instruction videos
7. Download documentation / forms


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News


HO104 news

01APR2016: The study is closed for inclusion of new patients because the target number has been reached. Included patients will be followed until 5 years after registration.

 

21JUL2015: Please note that the target of study patients is 57 (50 patients registered for Bortezemib, 7 'arm A' patients of the primary phase III study). Sites will be notified by email once the study is almost closed. 

 

2012: Please be aware that there is a restriction on the number of sites that can participate in this study, due to study-specific monitoring. At the moment, no extra sites can be added. If you have any questions, please contact the HOVON Data Center.

 

 

New documents:

22MAR2017: new version CRFs (v7)

15JUL2015: All mentioned documents are updated in relation to amendment 05

 - Protocol (clean + summary of changes)

 - ICF (clean + summary of changes)

 - Pre-study ICF

 - Echo review information

 - Belgium specific portfolio


1. Overview



Status

closed



Type of study

Prospective Phase II study


Echelon level specification

Limited site selection


Type of monitoring for this study

Study specific


Target number of patients

57


Current number of patients

57


Date of activation

03-Jan-2012


Date closed

01-Apr-2016


Approved by

NL:
CKTO: UU 2010-4884, 30NOV2010
CCMO: NL 33641.041.10 BI, 22NOV2010
cEC (UMCU): 10-426/G-O, 31AUG2011

B:
cEC(UZ Brussel): 2011/224, 25JUN2012
FAGG: 23NOV2011

D:
cEC: 09MAY2012
CA: 03MAY2012


Change history / amendement

Amendment 1 , protocol v5_18OCT2011 was submitted and approved before start inclusion d.d 20DEC2011.

Amendment 2 (a.o. protocol v6-08JUN2012) is submitted and approved in The Netherlands only, implementation date 24JUL2012.

Amendment 4 (protocol v8 04NOV2013) approved in The Netherlands only, implementation date 28APR2014
Approved in Belgium, implemantation date 08JUL2014
Germany will follow after approval.


Study objectives

To determine the efficacy of bortezomib plus dexamethasone induction therapy followed by
HDM and auto-SCT in patients with newly diagnosed AL amyloidosis who are 18-70 years
inclusive.

To asses the safety of bortezomib plus dexamethasone as induction treatment followed by
HDM and auto-SCT in patients with newly diagnosed AL amyloidosis who are 18-70 years
inclusive.


2. Patient eligibility 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 stage 1-2,
• Negative pregnancy test at inclusion for women of childbearing potential,
• Written informed consent.


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 orthostatic hypotension defined as a decrease in systolic blood pressure on standing of >20 mmHg 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 senstitivity
assay) or NT proBNP level > 5000 pg/ml and Troponin I > 2 times ULN,
• Positive for HIV or infectious hepatitis, B or C (screening obligatory),
• Bilirubin > 2x upper limit of normal,
• Creatinine 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-cell NHL or B-CLL,
• Previous organ transplantation,
• Unwilling or unable to use adequate contraception.


3. Registration (& randomization) of patients



Registration

Central registration at the HOVON Data Center:
Erasmus MC Cancer Institute, Clinical Trial Center (Hs-423)
P.O. Box 2040
NL-3000 CA Rotterdam

TOP address: https://www.hdc.hovon.nl/top
Fax number: +31.10.7041028
Phone number: +31.10.7041560 (working days 9.00 - 17.00)


Registration criteria

The following information will be requested:



Protocol number
Institution name
Name of caller
Responsible physician
Sex
Date of birth and
Patient separate consents
Eligibility criteria


4. Participating parties



Principal Investigator(s)

Mw. Dr. M.C. Minnema (UMCU)


Co-Investigator(s)

Dhr. Dr. B.P.C. Hazenberg (UMCG)
Dr. U. Hegenbart (Universität Heidelberg)
Dr. S. Schoenland (Universität Heidelberg)
Dhr. Dr. K.L. Wu (ZNA Stuivenberg)


Coordinating Investigator(s)

Dr. S. Schoenland (Universität Heidelberg)
Dr. R. Schots (Universitair Ziekenhuis Brussel)


Statistician(s)

Dhr. K. Nasserinejad (Erasmus MC - Centrum)


Monitor - Study Specific

MonitorTeamCTC (Erasmus MC - Daniel)


Other functions

Central Coordinator - MRD - Lab celdiagnostiek (UMCU)
Central Coordinator - MRD - J. van Velzen (UMCU)
Central Coordinator - Special Investigations - Dhr. J. Bijzet (UMCG)


Trial manager

N. (Nicole) Thuss (n.thuss@erasmusmc.nl)


5. Participating sites



Site
Included patients *
BE-Antwerpen-ZNA Stuivenberg
1
BE-Gent-UZ Gent
3
BE-Yvoir-Cliniques Universitaires de Mont-Godinne
0
DE-Hamburg-UMC Hamburg-Eppendorf
1
DE-Heidelberg-Universität Heidelberg
7
NL-Amsterdam-AMC
2
NL-Amsterdam-VUMC
5
NL-Den Haag-Hagaziekenhuis, locatie Leyweg
6
NL-Eindhoven-Maxima Medisch Centrum
3
NL-Enschede-Medisch Spectrum Twente
1
Show 8 more...
* Please note that if TOP is not used to register patients for a study, the number of patients shown is zero.

6. Instruction videos



7. Download documentation / forms


 Protocol



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