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Clinical picture: MM (Multiple Myeloom)
Trial: HOVON 86 MM
News
1. Overview
Study details
2. Patient eligibility criteria
3. Registration (& randomization) of patients
4. Participating parties
5. Participating sites
6. Instruction videos
7. Download documentation / forms
News
HO86 news
De HOVON 86 MM studie is op 23JAN12 gesloten.
Ik dank u allen hartelijk voor inzet en de eindspurt die er gemaakt is.
De planning is om de resultaten van de eerste 40 patiënten te publiceren op de komende EHA, de resultaten van alle patiënten zal worden ingediend op de komende ASH.
New and updated documents on this website:
-New Insurance certificate for BE sites is available (runs till 31DEC13) (11JUN13)
-New WMO insurance certificate for NL sites is available (runs till 01DEC13) (29JAN13)
-New WMO insurance certificate for NL sites is available (runs till 01JUL12) (dd 20JUN11)
-News letter 5 is available (18MAY11)
-New PPP (Pregnancy Prevention Program is available. please use version 3 instead of version 2)
-CRFs are updated (new version is 09FEB11) due to extraction of patient name code
In relation with the approval of amendment 2, the following documents have been updated on 23DEC10:
-Protocol (dd 11OCT10)
-Protocol amendments
-CRF (dd 11OCT10)
-Patient information & IC form (NL)
-PI&ICF amendment(s)
-CCMO response
-METC approval
-Signature page of protocol
- Registration (&randomisation) form
- Site documents checklist amendment 2
From the CRF set the cytogenetic pages were distracted and a new MM cytogenetic CRF was placed as a separate file under 'other documents' (22JUL10).
There is a new flowchart available that summarises the BM and PB sampling time, called: HO86_flowchart afname materiaal.pdf (added on 02FEB10)
Please find a new version of the WMO insurance certificate for this study below the study documents (added on 28DEC09)
In relation with the approval of amendment 1, the following documents have been updated on 03DEC09:
- Protocol (dd 07OCT09)
- Protocol amendments
- CRF (dd 07OCT09)
- Patient Information & IC form (NL)
- PI & ICF amendment(s)
- CCMO response
- MEC approval
- ABR form
- Signature page of protocol
- Registration (&randomisation) form
- SAE form
- Site documents checklist amendment 1
- Summary of canges ABR form
Previous updated documents:
- Medication Order Form, update June 2009
- Drug accountability form
- Instructions Central Lab, update June 2009
- WMO subject insurance
- HO86 Newsletter 3
In contrast with earlier communications we inform you that compensation of 20% for Velcade costs in this study will not be provided.
For the latest newsletter click under heading 'general' > 'news'
Previous newsletters can be found under 'other documents'
1. Overview
Summary
Phase I/II trial of Lenalidomide plus Bortezomib combined with Dexamethasone in patients in 1st relapse or primary refractory after first line therapy for Multiple Myeloma
Status
closed
Members
HOVON (NL + BE)
Study details
Type of study
Prospective Phase I/II study
Echelon level
Level C-HIC & C-SCT
Type of monitoring for this study
Site evaluation visits
Target number of patients
72
Current number of patients
81
Date of activation
15-Sep-2008
Approved by
EudraCTnr.: 2007-002533-37
Original approval:
NL_CA: 02APR08
NL_EC: METC Erasmus MC, 2008-115, 02JUN08
NL_CKTO: 2007-09/2007-4221, 21NOV07
BE_CA: 16OCT09
BE_EC: 30APR09
Change history / amendement
Amendment 1:
NL_CA: 11NOV09
NL_EC: 04NOV09
BE_CA: 27APR10
BE_EC: 18NOV10
Amendment 2:
NL_CA: 22DEC10
NL_EC: 31DEC10
Study objectives
Phase 1:
Primary objective
To determine the maximum tolerated dose (MTD) and recommended phase II dose level (RDL) of Bortezomib administered once weekly, and of Lenalidomide administered for 3 weeks when combined with Dexamethasone in a 28-days schedule. See paragraph 14 for definitions of MTD and RDL
Secondary objective
To evaluate toxicity, especially myelosuppression, polyneuropathy and thrombosis
Phase 2:
Primary objective
To investigate the efficacy of a maximum of 8 cycles of Bortezomib plus Lenalidomide with Dexamethasone at the RDL, as determined by the (s)CR+VGPR rate
Secondary objectives
To evaluate the effect of maintenance treatment with Lenalidomide in patients who have achieved any response (sCR, CR, VGPR, or PR) upon treatment with the combination of Bortezomib plus Lenalidomide with Dexamethasone
To evaluate toxicity, especially myelosuppression, polyneuropathy and thrombosis
To evaluate progression free survival
To evaluate overall survival
2. Patient eligibility criteria
Inclusion criteria
Multiple Myeloma Salmon/Durie stage II/III A+B
Primary refractory to or first relapse after previous objective response (PR, VGPR, CR) on standard first-line treatment
Age >=18 years inclusive
Not a candidate for high-dose therapy
Measurable disease, i.e., serum M-component (>10 g/l), or urinary light-chain excretion (>200mg/24h),or abnormal FLC ratio with involved free light chain (FLC) > 100 mg/l or proven plasmacytoma by biopsy
Able and/or willing to use adequate contraceptives (especially male patients)
Written informed consent
Exclusion criteria
Prior therapy with Bortezomib or Lenalidomide
History of allergic reaction attributable to compounds containing boron or mannitol.
Peripheral neuropathy or neuropathic pain Grade 2 or higher as defined by NCI CTCAE version 3.
AL amyloidosis
Uncontrolled or severe cardiovascular disease:
*New York Heart Association (NYHA) Class III or IV heart failure
*Myocardial infarction within the last 6 months of study entry
*Reduced left ventricular function with an ejection fraction < 50% as measured by MUGA scan or echocardiogram (another method for measuring cardiac function is acceptable)
*Unstable angina
*Unstable cardiac arrhythmias
*Clinically significant pericardial disease
Impaired hepatic or renal function as defined by:
*ALT and/or AST > 3 x normal value
*Bilirubin > 3 x normal value
*Serum creatinin > 3 x normal value (after adequate hydration)
Concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes, infection, hypertension, etc.)
Known HIV positivity
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
Phone number.: +31.10.7041560 (working days 9.00-17.00)
Fax number.....: +31.10.7041028
TOP address...: http://www.hdc.hovon.nl/top
Registration criteria
The following information will be requested:Protocol number
Institution name
Name of caller/responsible investigator
Patient's initials or code
Patient's hospital record number
Sex
Date of birth
Eligibility criteria
PLEASE NOTE:
DURING PHASE I PATIENTS CAN ONLY BE REGISTERED VIA TELEPHONE OR FAX.
4. Participating parties
Principal Investigator(s)
Prof. Dr. P. Sonneveld (Erasmus MC - Centrum)
Co-Investigator(s)
Prof. Dr. H.M. Lokhorst (VUMC)
Prof.Dr. E. Vellenga (UMCG)
Statistician(s)
Dr. W. Ghidey Alemayehu (Erasmus MC - Daniel)
Monitor - Site Evaluation Visits
Mw. W.M Keller (Erasmus MC - Daniel)
Mw. J. Kloezeman (Erasmus MC - Daniel)
Mw. T. van de Klundert (Erasmus MC - Daniel)
Dhr. T. Volker (Erasmus MC - Daniel)
T.F. van Wingerden (Erasmus MC - Daniel)
Other functions
Central Coordinator - Special Investigations - Dhr. Dr. M. van Duin (Erasmus MC - Daniel)
Central Coordinator - Special Investigations - Mw. Y. de Knegt (Erasmus MC - Centrum)
Central Coordinator - Special Investigations - Dhr. M. Schoester (Erasmus MC - Centrum)
Central Coordinator - Special Investigations - Mw. J. Veth (Erasmus MC - Centrum)
Reviewer - Cytogenetics - Mw. Dr. H.B. Beverloo (Erasmus MC - Medische Faculteit)
Other functions
Cytogenetic reviewers:
Daniel OldeWeghuis, Arjan Buijs, Marian Stevens-Kroef
5. Participating sites
* Please note that if TOP is not used to register patients for a study, the number of patients shown is zero.
