Condition category
Cancer
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
17/11/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.hovon.nl

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

http://www.hovon.nl/

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

Publication citations

Additional files

Editorial Notes