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.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON26780

Enrollment

407

Registered

2005-09-06

Start date

2004-04-19

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Myeloma

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: Zoledr

Eligibility

Inclusion criteria

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

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 2.80 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.

Design outcomes

Primary

Measure	Time frame
Time to the occurence of the first skeletal related event, from randomization.	—

Secondary

Measure	Time frame
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.	—

Contacts

Public ContactP. Sonneveld

P.O. Box 2040

p.sonneveld@erasmusmc.nl+31 (0)10 7033589

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)