Contact information
Type
Scientific
Primary contact
Prof P Sonneveld
ORCID ID
Contact details
Erasmus University Medical Centre
Department of Haematology
P.O. Box 2040
Rotterdam
3000 CA
Netherlands
+31 (0)10 463 3589
p.sonneveld@erasmusmc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HO57; NTR233
Study information
Scientific title
Acronym
HOVON 50 MM
Study hypothesis
Evaluation of the effect of zoledronate i.v. treatment duration in addition to chemotherapy.
Ethics approval
Received from the local medical ethics committee
Study design
Multicentre, randomised, active controlled, parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Phase III
Drug names
Zoledronate
Primary outcome measures
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 trial start date
19/04/2004
Overall trial end date
19/04/2007
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
407
Participant 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
Recruitment start date
19/04/2004
Recruitment end date
19/04/2007
Locations
Countries of recruitment
Netherlands
Trial participating centre
Erasmus University Medical Centre
Rotterdam
3000 CA
Netherlands
Sponsor information
Organisation
Dutch Haemato-Oncology Association (Stichting Hemato-Oncologie Volwassenen Nederland) (HOVON) (Netherlands)
Sponsor details
Vrije University Medical Centre (VUMC)
PO Box 7057
Amsterdam
1007 MB
Netherlands
+31 (0)20 444 2693
hdc@hovon.nl
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
Dutch Haemato-Oncology Association (Stichting Hemato-Oncologie Volwassenen Nederland) (HOVON) (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
The National Cancer Fund (Koningin Wilhelmina Fonds [KWF]) (The 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