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Clinical picture: MM (Multiple Myeloom)

Trial: HOVON 41 AL Amyloidosis


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


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News


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1. Overview



Summary

Autologous Stem Cell Transplantation for Patients with AL Amyloidosis: A Prospective Phase II Study.


Status

closed



Study details



Type of study

Prospective Phase II study


Target number of patients

50


Date of activation

04-Sep-2002


Date closed

31-Jan-2006


Approved by

CKVO: CKVO 2000-03


Study objectives

To determine in a prospective phase II study the efficacy of intensive treatment including peripheral blood stem cell transplantation with regard to clonal response rate, clinical response rate and overall survival.
To assess the feasibility of this approach i.e. percentage of patients who will receive an autologous transplantation
To assess the value of risk factors at diagnosis, like performance status and organ involvement, for individual patients with AL amyloidosis in relation with dose intensive treatment


2. Patient eligibility criteria



Inclusion criteria

Age under 66 years
MGUS, multiple myeloma stage I
Histologically documented systemic AL amyloidosis (see appendix C)
Untreated or previously treated with maximal 3 courses of melphalan and prednisone
The patient must give informed consent according to the rules of the hospital.


Exclusion criteria

Prior malignancies diagnosed less than 5 years ago, except non-melanoma skin tumours or stage 0 (in situ) cervical carcinoma. Note: Prior malignancies diagnosed and treated longer than 5 years ago, and in which case it is likely that the patient is cured, are no exclusion criteria.
Patients with familial variants of systemic amyloidosis.
Severe pulmonary, neurologic, psychiatric, cardiac, liver or metabolic disease not related to AL amyloidosis.


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
Patientís initials or code
Patientís hospital record number
Sex
Date of birth
Eligibility criteria


4. Participating parties



Principal investigator

H.M. Lokhorst (H.Lokhorst@digd.azu.nl)


Coordinating investigator(s)

A.J. Croockewit
B. Hazenberg


Statistician(s)

B. van der Holt (b.vanderholt@erasmusmc.nl)


Trial manager

M.C.J. Testroote (m.testroote@erasmusmc.nl)


Central data management

M.C.J. Testroote (m.testroote@erasmusmc.nl)


5. Participating sites



6. Instruction videos



7. Download documentation / forms


 Protocol



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