Phase 4
N=179
A Multiple Myeloma Trial in Patients With Bone Metastases
Multiple Myeloma
Bottom Line
View on ClinicalTrials.gov: NCT00104104 ↗Enrolled (actual)
179
Serious AEs
38.5%
Results posted
Jun 2011
Primary outcome: Primary: The Number of Participants With a Significant Increase in Serum Creatinine at 12 Months — 17; 13 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- zoledronic acid (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Oct 2007
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 | — |
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.
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.