Phase 4
Completed N=179
A Multiple Myeloma Trial in Patients With Bone Metastases
Source: ClinicalTrials.gov NCT00104104 ↗Enrolled (actual)
179
Serious AEs
38.5%
Results posted
Jun 2011
Primary outcomePrimary: The Number of Participants With a Significant Increase in Serum Creatinine at 12 Months — 17; 13 Participants
Summary
The purpose of this trial is to study the safety of treating patients with multiple myeloma and at least one bone lesion with zoledronic acid 4mg intravenously (IV) every 3 - 4 weeks for 2 years. Patients will receive a zoledronic acid infusion for 15 minutes or 30 minutes.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Number of Participants With a Significant Increase in Serum Creatinine at 12 Months |
17; 13 | — |
| PRIMARY The Number of Participants With Disease Progression |
28; 20 | — |
| SECONDARY The Number of Participants With a Significant Increase in Serum Creatinine at 24 Months |
24; 23 | — |
| SECONDARY Time to First Significant Increase in Serum Creatinine |
21.6; 24.4 | — |
| SECONDARY Zoledronic Acid Concentrations |
231.1; 186.3; 248.8; 172.0 | — |
Eligibility Criteria
Inclusion Criteria
- Patients 18 years of age or older
- Confirmed diagnosis of Multiple Myeloma
- Stable renal function defined as two serum creatinine determinations of < 3 mg/dL
- Calculated creatinine clearance of greater than or equal to 30 mL/min
- ECOG Performance Status of 0 or 1
- Life expectancy of greater than or equal to 9 months
- If the patient is of child-bearing potential, a negative pregnancy test is required at screening, while postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential.
- Ability to comply with trial requirements and give informed consent.
Exclusion Criteria
- IV Bisphosphonate therapy for more than 3 years.
- Patients with a diagnosis of amyloidosis.
- Known hypersensitivity to zoledronic acid or other bisphosphonates
- Pregnant patients or lactating patients.
- Women of childbearing potential not on a medically recognized form of contraception
- Patients with uncontrolled cardiovascular disease, hypertension, and Type 2 diabetes mellitus.
Data sourced from ClinicalTrials.gov (NCT00104104). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.