Randomised phase III study in elderly patients with a multiple myeloma on the value of Thalidomide added to Melphalan plus Prednisone
| ISRCTN | ISRCTN90692740 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN90692740 |
| Secondary identifying numbers | NTR232; Ho49 |
- Submission date
- 20/12/2005
- Registration date
- 20/12/2005
- Last edited
- 04/02/2011
- 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 P.W. Wijermans
Scientific
Scientific
Haga Hospital, location Leyenburg Hospital
Department of Hematology
P.O. Box 40551
Den Haag
2504 LN
Netherlands
| Phone | +31 (0)70 3592556 |
|---|---|
| p.wijermans@hagaziekenhuis.nl |
Study information
| Study design | Multicentre randomised open label active controlled parallel trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | |
| Study acronym | HOVON 49 MM |
| Study objectives | The outcome in arm B is better than in arm A. |
| Ethics approval(s) | METC Ziekenhuis Leyenburg on the 23rd April 2002 Ref: 02.012 |
| Health condition(s) or problem(s) studied | Multiple Myeloma |
| Intervention | Patients will be randomized on entry between: Arm A: 8 cycles of Melphalan + Prednisone Arm B: 8 cycles of Melphalan + Prednisone + Thalidomide Non responders will be taken off protocol treatment after 3 cycles of therapy. If after 8 cycles a plateau-phase is reached therapy can be stopped. If after 8 cycles a patient still shows improvement of the disease, therapy will be continued until a plateau phase has been reached. Thalidomide (50 mg/day) in arm B will be continued until disease progression. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Thalidomide, melphalan, prednisone |
| Primary outcome measure | 1. Event free survival (i.e. time from registration to induction failure, death, progression or relapse whichever occurs first) 2. Response rate (complete response [CR] or partial response [PR]) |
| Secondary outcome measures | 1. Quality of life 2. Toxicity of the combination therapy 3. Overall survival measured from time of registration. Patients still alive or lost to follow up are censored at the date they were last known to be alive. 4. Progression free survival measured from the time of achievement of PR (or CR) to date of relapse, progression or death from any cause (whichever occurs first) |
| Overall study start date | 01/08/2002 |
| Completion date | 01/01/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 420 |
| Key inclusion criteria | 1. Patients with a confirmed diagnosis of multiple myeloma stage Ib, II or III according to the Salmon & Durie criteria 2. Age >65 years 3. WHO performance status 0-3 4. Measurable tumorparameter (M-protein or Bence Jones proteïnuria) 5. Written informed consent |
| Key exclusion criteria | 1. Known intolerance to Thalidomide 2. Systemic AL amyloidosis 3. Polyneuropathy 4. Severe cardiac dysfunction (NYHA classification II-IV) 5. Severe pulmonary dysfunction 6. Significant hepatic dysfunction (serum bilirubin ≥30 mmol/l or transaminases ≥25 times normal level), unless related to myeloma 7. Renal failure with dependency on dialysis 8. Patients with active, uncontrolled infections 9. Pre-treatment with cytostatic drug or alpha interferon 10. Patients known to be HIV-positive 11. Patients with a history of active malignancy during the past 5 years with the exception of basal carcinoma of the skin or stage 0 cervical carcinoma |
| Date of first enrolment | 01/08/2002 |
| Date of final enrolment | 01/01/2007 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Haga Hospital, location Leyenburg Hospital,
Den Haag
2504 LN
Netherlands
2504 LN
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
Charity
The National Cancer Fund (Koningin Wilhelmina Fonds [KWF]) (Netherlands)
No information available
Dutch Haemato-oncology Association (Stichting Hemato-Oncologie voor Volwassenen Nederland [HOVON]) (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 | 01/07/2010 | Yes | No | |
| Results article | results | 17/03/2011 | Yes | No |
