|- candidate number||1409|
|- NTR Number||NTR233|
|- Date ISRCTN created||20-dec-2005|
|- date ISRCTN requested||18-okt-2005|
|- Date Registered NTR||6-sep-2005|
|- Secondary IDs||HO57 |
|- Public Title||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.|
|- Scientific Title||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.|
|- ACRONYM||HOVON 50 MM|
|- hypothesis||The hypothesis to be tested is that the outcome in arm B is better than in arm A.|
|- Healt Condition(s) or Problem(s) studied||Multiple myeloma (Kahler's disease)|
|- Inclusion criteria||1. 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 criteria||1. 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 received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||19-apr-2004|
|- planned closingdate||19-apr-2007|
|- Target number of participants||407|
|- Interventions||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 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 outcome||Time to the occurence of the first skeletal related event, from randomization.|
|- Secondary outcome||1. 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.
|- Trial web site||http://www.hovon.nl|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES||Prof. Dr. P. Sonneveld|
|- CONTACT for SCIENTIFIC QUERIES||Prof. 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 |
(Source(s) of Monetary or Material Support)
|Koningin Wilhelmina Fonds (KWF), Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON)|
|- Brief summary||Study phase: |
Evaluation of the effect of zoledronate i.v. treatment duration in addition to chemotherapy.
Patients with multiple myeloma, previously untreated, Salmon & Durie stage II or III, age >= 18 years, included in HOVON 49 or HOVON 50 trial.
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)|
|- RECORD||6-sep-2005 - 27-nov-2009|