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
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