A randomised phase III study of intravenous (i.v.) zoledronate (administered for 12 versus 36 months) as an adjunct to standard therapies in the treatment of multiple myeloma
| ISRCTN | ISRCTN23172547 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN23172547 |
| Secondary identifying numbers | HO57; NTR233 |
- Submission date
- 20/12/2005
- Registration date
- 20/12/2005
- Last edited
- 17/11/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof P Sonneveld
Scientific
Scientific
Erasmus University Medical Centre
Department of Haematology
P.O. Box 2040
Rotterdam
3000 CA
Netherlands
| Phone | +31 (0)10 463 3589 |
|---|---|
| p.sonneveld@erasmusmc.nl |
Study information
| Study design | Multicentre, randomised, active controlled, parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study acronym | HOVON 50 MM |
| Study objectives | Evaluation of the effect of zoledronate i.v. treatment duration in addition to chemotherapy. |
| Ethics approval(s) | Received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | Multiple myeloma |
| Intervention | All patients will receive zoledronate 4 mg as a 15-minute i.v. infusion every 4 weeks for 12 months. After 12 months these patients will be randomised between: 1. Arm A: off treatment 2. Arm B: zoledronate 4 mg as a 15-minute i.v. infusion every 4 weeks for 24 months |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Zoledronate |
| Primary outcome measure | Time to the occurrence of the first skeletal related event, from randomisation. |
| Secondary outcome measures | 1. The incidence of SREs per patient in the first 36 months from randomisation 2. Time to first SRE from registration 3. Time to progression of bone metastasis 4. Time to overall progression of disease 5. Performance status (WHO) 6. Quality of life (QLQ-C30) 7. Bone resorption markers 8. Objective bone lesion response from radiological studies |
| Overall study start date | 19/04/2004 |
| Completion date | 19/04/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 407 |
| Key inclusion criteria | 1. Patients with a confirmed diagnosis of multiple myeloma stage II or III according to the Salmon and Durie criteria 2. Patients with at least one osteolytic bone lesion on conventional radiographs (plain film) 3. Inclusion in HOVON 49 or HOVON 50 trial 4. Inclusion in HOVON 57 at the same time as inclusion in HOVON 49 or HOVON 50 5. Date of inclusion in HOVON 57 trial before date start chemotherapy HOVON 49 or HOVON 50 6. Aged greater than or equal to 18 years 7. World Health Organization (WHO) performance status 0 - 3 8. Negative pregnancy test at inclusion if applicable 9. Written informed consent |
| Key exclusion criteria | 1. Treatment with bisphosphonates at any time during the 12 months prior to registration. Exception: patients may have received up to three doses of a bisphosphonate for hypercalcaemia provided this has been administered greater than 14 days prior to registration 2. Corrected (adjusted for serum albumin) serum calcium less than 200 mmol/l or greater than 280 mmol/l 3. Serum creatinine greater than 265 micromol/l 4. Total bilirubin greater than 30 micromol/l 5. Patients unwilling or unable to comply with protocol 6. Severe cardiac dysfunction (New York Heart Association [NYHA] classification III - IV) 7. Patients with clinically significant hypersensitivity to zoledronic acid or other bisphosphonates 8. Patients who are not willing or capable to use adequate contraception during the therapy (all men, all pre-menopausal women) 9. Lactating patients if applicable |
| Date of first enrolment | 19/04/2004 |
| Date of final enrolment | 19/04/2007 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Erasmus University Medical Centre
Rotterdam
3000 CA
Netherlands
3000 CA
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) (The Netherlands)
No information available
The National Cancer Fund (Koningin Wilhelmina Fonds [KWF]) (The 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 |
