A randomised phase III study on the effect of thalidomide combined with Adriamycin®, dexamethasone and high dose melphalan in patients with multiple myeloma
| ISRCTN | ISRCTN06413384 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN06413384 |
| ClinicalTrials.gov number | NCT00028886 |
| Secondary identifying numbers | HO50 |
- Submission date
- 20/12/2005
- Registration date
- 20/12/2005
- Last edited
- 03/10/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr H M Lokhorst
Scientific
Scientific
University Medical Centre Utrecht
Department of Haematology
PO Box 85500
Utrecht
3508 GA
Netherlands
| Phone | +31 (0)30 250 7230 |
|---|---|
| h.lokhorst@digd.azu.nl |
Study information
| Study design | Multicentre randomised active controlled parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | A randomised phase III study on the effect of thalidomide combined with Adriamycin®, dexamethasone and high dose melphalan in patients with multiple myeloma |
| Study acronym | HOVON 50 MM/GMMG-HD3 |
| Study objectives | Study objectives: Evaluation of the effect of thalidomide in addition to Adriamycin, Dexamethasone (AD) and high dose melphalan. The hypothesis to be tested is that the outcome in arm B is better than in arm A. |
| Ethics approval(s) | Ethics approval received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | Multiple myeloma |
| Intervention | Patients with multiple myeloma, meeting all eligibility criteria will be randomised on entry between: Arm A: Standard Vincristine, Adriamycin and Dexamethasone (VAD) induction, followed by intensive chemotherapy with High-dose Melphalan, followed by maintenance therapy with alpha-interferon Arm B: Induction chemotherapy with Thalidomide, Adriamycin and Dexamethasone (TAD) followed by intensive chemotherapy with High-dose Melphalan, followed by maintenance with Thalidomide |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Standard Vincristine, Doxorubicin (Adriamycin®) and Dexamethasone (VAD) induction, thalidomide, Adriamycin®, dexamethasone, melphalan, alpha-interferon |
| Primary outcome measure | Event-free survival (i.e. time from registration to induction failure, progression or death, whichever occurs first); the time to failure of patients with induction failure is set at one day. Patients are considered induction failure when they have not achieved at least a Partial response (PR) and are not eligible for further treatment according to protocol. |
| Secondary outcome measures | 1. Response (PR and Complete Response [CR]) 2. Overall survival measured form the time of registration. Patient still alive or lost to follow up are censored at the date they were last known to be alive 3. Progression free survival (duration of the first response [PR or CR]) measured from the time of achievement of PR (or CR) to date of progression or death from any cause (whichever occurs first) 4. Toxicities of thalidomide and chemotherapy |
| Overall study start date | 27/11/2001 |
| Completion date | 01/06/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 450 |
| Key inclusion criteria | 1. Patients with a confirmed diagnosis of multiple myeloma stage II or III according to the Salmon and Durie criteria 2. Age 18 to 65 years inclusive 3. World Health Organisation (WHO) performance status zero to three 4. Negative pregnancy test at inclusion if applicable 5. Written informed consent |
| Key exclusion criteria | 1. Known intolerance to thalidomide 2. Systemic AL amyloidosis 3. Previous chemotherapy or radiotherapy except two cycles of melphalan/prednisone or local radiotherapy in case of local myeloma progression 4. Severe cardiac dysfunction (New York Heart Association [NYHA] classification II to IV) 5. Significant hepatic dysfunction (serum bilirubin greater than or equal to 30 micromol/l or transaminases greater than or equal to 25 times normal level), unless related to myeloma 6. Patients known to be Human Immunodeficiency Virus (HIV)-positive 7. Patients with active, uncontrolled infections 8. Patients with a history of active malignancy during the past five years with the exception of basal carcinoma of the skin or stage 0 cervical carcinoma 9. Patients who are not willing or capable to use adequate contraception during the therapy (all men, all pre-menopausal women) 10. Patients less than or equal to 55 years with a Human Leukocyte Antigen (HLA)-identical sibling who will undergo myeloablative Allogeneic Stem Cell Transplantation (AlloSCT) |
| Date of first enrolment | 27/11/2001 |
| Date of final enrolment | 01/06/2005 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
University Medical Centre Utrecht
Utrecht
3508 GA
Netherlands
3508 GA
Netherlands
Sponsor information
Dutch Haemato-Oncology Association (Stichting Hemato-Oncologie Volwassenen Nederland) (HOVON) (Netherlands)
Research organisation
Research organisation
Vrije University Medical Centre (VUMC)
PO Box 7057
Amsterdam
1007 MB
Netherlands
| Phone | +31 (0)20 444 2693 |
|---|---|
| hdc@hovon.nl | |
| Website | http://www.hovon.nl/ |
"ROR" |
https://ror.org/056kpdx27 |
Funders
Funder type
Research organisation
Dutch Haemato-Oncology Association (Stichting Hemato-Oncologie Volwassenen Nederland) (HOVON) (Netherlands)
No information available
The National Cancer Fund (Koningin Wilhelmina Fonds [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? |
|---|---|---|---|---|---|
| Protocol article | protocol | 01/10/2003 | Yes | No | |
| Results article | results | 01/06/2007 | Yes | No | |
| Results article | results | 11/02/2010 | Yes | No | |
| Results article | results | 01/12/2015 | Yes | No |
Editorial Notes
03/10/2016: Publication reference added.
