Condition category
Nutritional, Metabolic, Endocrine
Date applied
26/10/2010
Date assigned
11/11/2010
Last edited
13/02/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.hovon.nl

Contact information

Type

Scientific

Primary contact

Prof Henk Lokhorst

ORCID ID

Contact details

Dept. of Hematology
UMCU
P.O. box 85500
Utrecht
3508 GA
Netherlands

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Ho41

Study information

Scientific title

Autologous stem cell transplantation for patients with AL amyloidosis. A prospective phase II study

Acronym

HOVON 41 AL AMYLOIDOSIS

Study hypothesis

Treatment with myelo-ablative chemotherapy and autologous stem cell transplantation in patients with AL amyloidosis is feasible and efficacy meets the expectations as described in the protocol.

Further reading:
New Eng.J.Med. 2008 Jan3; 358(1):92: author reply 92-3.
High-dose melphalan versus melphalan plus dexamethasone for AL amyloidosis.
Lokhorst HM, Hazenberg BP, Croockewit A.
http://www.ncbi.nlm.nih.gov/pubmed/18172953

Ethics approval

The Ethics Committee of University Medical Centre (UMC) Utrecht approved on the 1st of August 2000

Study design

Prospective multicentre single arm non-randomised trial

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details below to request a patient information sheet

Condition

Amyloid light-chain (AL) amyloidosis

Intervention

Patients will be undergo the following treatments:
1. VAD induction treatment (3-4 weeks) courses, consisting of vincristine, doxorubicin (Adriamycin®), dexamethasone
2. Stem cell mobilization with G-CSF
3. Melphalan 200 mg/m2 treatment, followed by peripheral blood stem cell transplantation or unprocessed G-CSF-primed whole blood reinfusion

Intervention type

Drug

Phase

Phase II

Drug names

VAD (Vincristine, doxorubicin [Adriamycin®], dexamethasone)

Primary outcome measures

1. Response (clonal and clinical)
2. Overall survival.

Secondary outcome measures

Percentage of patients that will ultimately receive an autologous transplant.

Overall trial start date

04/09/2000

Overall trial end date

01/01/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age 18-65 years incl.
2. Monoclonal Gammopathy of Undetermined Significance (MGUS), multiple myeloma stage I
3. Histologically documented systemic AL amyloidosis
4. Untreated or previously treated with maximal 3 courses of melphalan and prednisone
5. The patient must give informed consent according to the rules of the hospital

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

70

Participant exclusion criteria

1. Prior malignancies diagnosed less than 5 years ago, except non-melanoma skin tumours or stage 0 (in situ) cervical carcinoma
2. Patients with familial variants of systemic amyloidosis
3. Severe pulmonary, neurologic, psychiatric, cardiac, liver or metabolic disease not related to AL amyloidosis

Recruitment start date

04/09/2000

Recruitment end date

01/01/2011

Locations

Countries of recruitment

Belgium, Netherlands

Trial participating centre

Dept. of Hematology
Utrecht
3508 GA
Netherlands

Sponsor information

Organisation

Dutch Haemato-Oncology Association (Stichting Hemato-Oncologie Volwassenen Nederland) (HOVON) (Netherlands)

Sponsor details

P/a HOVON Data Center
Erasmus MC - Daniel den Hoed
P.O. box 5201
Rotterdam
3008 AE
Netherlands

Sponsor type

Research organisation

Website

http:\\www.hovon.nl

Funders

Funder type

Research organisation

Funder name

Dutch-Belgian Cooperative Trial Group for Hematology Oncology (HOVON) (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Dutch Cancer Fund (KWF) (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25661441

Publication citations

Additional files

Editorial Notes