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A randomized phase III study of i.v. zoledronate (administered for 12 versus 36 months) as an adjunct to standard therapies in the treatment of multiple myeloma. A phase III study.


- candidate number1409
- NTR NumberNTR233
- ISRCTNISRCTN23172547
- Date ISRCTN created20-dec-2005
- date ISRCTN requested18-okt-2005
- Date Registered NTR6-sep-2005
- Secondary IDsHO57 
- Public TitleA randomized phase III study of i.v. zoledronate (administered for 12 versus 36 months) as an adjunct to standard therapies in the treatment of multiple myeloma. A phase III study.
- Scientific TitleA randomized phase III study of i.v. zoledronate (administered for 12 versus 36 months) as an adjunct to standard therapies in the treatment of multiple myeloma. A phase III study.
- ACRONYMHOVON 50 MM
- hypothesisThe hypothesis to be tested is that the outcome in arm B is better than in arm A.
- Healt Condition(s) or Problem(s) studiedMultiple myeloma (Kahler's disease)
- Inclusion criteria1. Patients with a confirmed diagnosis of multiple myeloma stage II or III according to the Salmon & 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. Age >=18 years;
7. WHO performance status 0-3;
8. Negative pregnancy test at inclusion if applicable;
9. Written informed consent.
- Exclusion criteria1. Treatment with bisphosphonates at any time during the 12 months prior to registration. Exception: patients may have received up to 3 doses of a bisphosphonate for hypercalcaemia provided this has been administered > 14 days prior to registration;
2. Corrected (adjusted for serum albumin) serum calcium < 2.00 mmol/l or > 2.80 mmol/l;
3. Serum creatinin > 265 micromol/l;
4. Total bilirubin > 30 micromol/l;
5. Patients unwilling or unable to comply with protocol;
6. Severe cardiac dysfunction (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.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 19-apr-2004
- planned closingdate19-apr-2007
- Target number of participants407
- InterventionsAll 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 randomized between:
- Arm A: Off treatment
- Arm B: Zoledronate 4 mg as a 15-minute i.v. infusion every 4 weeks for 24 months.
- Primary outcomeTime to the occurence of the first skeletal related event, from randomization.
- Secondary outcome1. The incidence of SREs per patient in the first 36 months from randomization;
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.
- TimepointsN/A
- Trial web sitehttp://www.hovon.nl
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESProf. Dr. P. Sonneveld
- CONTACT for SCIENTIFIC QUERIESProf. Dr. P. Sonneveld
- Sponsor/Initiator VU University Medical Center, Dutch haemato-oncology association (Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON), Erasmus Medical Center, Daniel den Hoed Cancer Center
- Funding
(Source(s) of Monetary or Material Support)
Koningin Wilhelmina Fonds (KWF), Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON)
- PublicationsN/A
- Brief summaryStudy phase:
Phase III.

Study objectives:
Evaluation of the effect of zoledronate i.v. treatment duration in addition to chemotherapy.

Patient population:
Patients with multiple myeloma, previously untreated, Salmon & Durie stage II or III, age >= 18 years, included in HOVON 49 or HOVON 50 trial.

Study design:
Prospective, multicenter, randomized.

Duration of treatment:
Expected duration of zoledronate treatment is 12 months in arm A and 36 months in arm B.

Number of patients:
244 randomized patients (which corresponds with about 407 registered patients).
- Main changes (audit trail)
- RECORD6-sep-2005 - 27-nov-2009


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