Autologous stem cell transplantation for patients with amyloid light chain (AL) amyloidosis
| ISRCTN | ISRCTN01207094 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN01207094 |
| Secondary identifying numbers | Ho41 |
- Submission date
- 26/10/2010
- Registration date
- 11/11/2010
- Last edited
- 13/02/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Henk Lokhorst
Scientific
Scientific
Dept. of Hematology
UMCU
P.O. box 85500
Utrecht
3508 GA
Netherlands
Study information
| Study design | Prospective multicentre single arm non-randomised trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details below to request a patient information sheet |
| Scientific title | Autologous stem cell transplantation for patients with AL amyloidosis. A prospective phase II study |
| Study acronym | HOVON 41 AL AMYLOIDOSIS |
| Study objectives | 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(s) | The Ethics Committee of University Medical Centre (UMC) Utrecht approved on the 1st of August 2000 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | VAD (Vincristine, doxorubicin [Adriamycin®], dexamethasone) |
| Primary outcome measure | 1. Response (clonal and clinical) 2. Overall survival. |
| Secondary outcome measures | Percentage of patients that will ultimately receive an autologous transplant. |
| Overall study start date | 04/09/2000 |
| Completion date | 01/01/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 70 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 04/09/2000 |
| Date of final enrolment | 01/01/2011 |
Locations
Countries of recruitment
- Belgium
- Netherlands
Study participating centre
Dept. of Hematology
Utrecht
3508 GA
Netherlands
3508 GA
Netherlands
Sponsor information
Dutch Haemato-Oncology Association (Stichting Hemato-Oncologie Volwassenen Nederland) (HOVON) (Netherlands)
Research organisation
Research organisation
P/a HOVON Data Center
Erasmus MC - Daniel den Hoed
P.O. box 5201
Rotterdam
3008 AE
Netherlands
| Website | http:\\www.hovon.nl |
|---|---|
"ROR" |
https://ror.org/056kpdx27 |
Funders
Funder type
Research organisation
Dutch-Belgian Cooperative Trial Group for Hematology Oncology (HOVON) (Netherlands)
No information available
Dutch Cancer Fund (KWF) (Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/05/2015 | Yes | No |
