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

Completed

• Conditions: Multiple myeloma; Cancer; Multiple myeloma and malignant plasma cell neoplasms

• Registration Number: ISRCTN23172547
• Lead Sponsor: Dutch Haemato-Oncology Association (Stichting Hemato-Oncologie Volwassenen Nederland) (HOVON) (Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-12-20
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 407

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to the occurrence of the first skeletal related event, from randomisation.

Secondary Outcome Measures

Name	Time	Method
1. The incidence of SREs per patient in the first 36 months from randomisation<br>2. Time to first SRE from registration<br>3. Time to progression of bone metastasis<br>4. Time to overall progression of disease<br>5. Performance status (WHO)<br>6. Quality of life (QLQ-C30)<br>7. Bone resorption markers<br>8. Objective bone lesion response from radiological studies