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Clinical picture: MM (Multiple Myeloom)

Trial: HOVON 108 MM


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


HO108 news

Closure of study

The study is closed for further inclusion from 05SEP13 onwards.

New documents:

20MAR13: Upload of HO108 specific IMP documentation. Please use these instead of the commercially available version.

20SEP12: New statement of expenses form (with addition of patient numbers)

22MAR12: Update of following documents regarding amendment 3:

- EC approval portfolio

- CA approval portfolio

- Protocol (clean version + summary of changes)

17JAN12: Declaration form (QOL expenses added)

16JAN12: Update of following documents regarding amendment 2:

- EC approval portfolio

- CA approval portfolio

- Protocol (clean version + summary of changes)

- ICF (clean version + summary of changes)

- CRF (clean version + summary of changes)

10JAN12: Addition of Labmanual (version 3 - 10JAN11)

23NOV11: Addition of declaration form

21NOV11: NEW SAE form, changed fax number, please use HO108_SAE form_21NOV11

26OCT11: NEW SAE form, based on template version 03 


1. Overview



Summary

A randomized phase II study for evaluation of T cell depleted non-myeloablative allogeneic stem cell transplantation followed by early consolidation with lenalidomide or lenalidomide combined with bortezomib and subsequent DLI for patients with multiple myeloma in progression or relapse following first line therapy


Status

closed


Members

HOVON



Type of study

Prospective randomized Phase II study


Echelon level

Level A


Echelon level specification

Due to the alloSCT treatment within this trial, only academical centers are allowed to participate within this study.


Type of monitoring for this study

Site evaluation visits


Target number of patients

110


Current number of patients

30


Date of activation

01-Jul-2011


Approved by

EC (CCMO): 19MAY11
CA (VWS): 16SEP10
CKS: 06JUL10


Change history / amendement

AM1: update of insurance certificate
AM2: change in eligibility questions + extra profylaxe
AM3: reduction on amount of IMPs


Study objectives

Assesment of feasibility, toxicity and efficacy of lenalidomide and of lenalidomide combined with bortezomib as early consolidation after T cell depleted non myeloablative Allo-SCT and before DLI; Asssessment of the efficacy of non myeloablative Allo-SCT as treatment of relapsed multiple myeloma in terms of complete remission rate, overall and progression free survival.


2. Patient eligibility criteria



Inclusion criteria

Patients with multiple myeloma with a first relapse after first line therapy;
Relapsed patients have received reinduction therapy before entering this trial;
At least a PR after reinduction treatment
18-65 years, inclusive;
HLA- identical sibling or unrelated donor completely matched (10/10)
WHO-performance status 0-2;
Written informed consent.


Exclusion criteria

Previous Allo-SCT;
Severe pulmonary dysfunction (CTCAE grade III-IV, see appendix D);
Severe neurological or psychiatric disease;
Patients with neuropathy, CTC grade 3 or higher;
Significant hepatic dysfunction (serum bilirubin or transaminases ≥ 3 times upper limit of normal);
Significant renal dysfunction (creatinine clearance < 30 ml/min after rehydration);
Concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes, infection, hypertension, cancer, etc.);
History of active malignancy during the past 5 years with the exception of basal carcinoma of the skin or or carcinoma “in situ” of the cervix or breast;
Patient known to be HIV-positive;
Patients with brain disease with the exception of those patients whose brain disease has been treated with either radiotherapy or surgery and remains asymptomatic, with no active brain disease, as shown by CT scan or MRI, for at least 6 months;
The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide, lenalidomide or borium;
Pregnant or breast-feeding female patients. Negative pregnancy test at study is mandatory for female patients of childbearing potential,
Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule;
Severe cardiac dysfunction (NYHA classification II-IV, see appendix E).


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 10 704 1560 (working days 9.00-17.00)
Fax number: +31 10 704 1028
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
Local patient code (optional)
Sex
Date of birth
Date written informed consent
Specific items patient gives consent for (see ICF)
Eligibility criteria
Stratification factors


4. Participating parties



Principal Investigator(s)

Prof. Dr. H.M. Lokhorst (VUMC)


Co-Investigator(s)

Dr. P.A. von dem Borne (Leids Universitair Medisch Centrum)
Mw. M.J. Kersten (AMC)


Statistician(s)

Dhr. Dr. B. van der Holt (Erasmus MC - Daniel)


Trial Manager(s)

Mw. P.B. Cornelisse (Erasmus MC - Daniel)


Monitor - Site Evaluation Visits

Mw. W.M Keller (Erasmus MC - Daniel)
Mw. L. Sitniakowsky (Erasmus MC - Daniel)
Dhr. T. Volker (Erasmus MC - Daniel)


Other functions

Central Coordinator - Special Investigations - I.S. Nijhof (UMCU)
Central Coordinator - Special Investigations - Researchteam Hema UMCU (UMCU)
Reviewer - Cytogenetics - Dhr. Dr. A. Buijs (UMCU)


5. Participating sites



Site
Included patients *
NL-Amsterdam-AMC
4
NL-Amsterdam-VUMC
5
NL-Leiden-Leids Universitair Medisch Centrum
6
NL-Maastricht-AZ Maastricht
1
NL-Nijmegen-Radboudumc
3
NL-Rotterdam-Erasmus MC - Daniel
3
NL-Utrecht-UMCU
8

* 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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