Clinical trial · Interventional
A Multiple Myeloma Trial in Patients With Bone Metastases
A Multicenter,Open Label, Randomized Trial Evaluating the Duration of Infusion of Zoledronic Acid 4 mg IV in Multiple Myeloma Patients With Bone Metastases
NCT00104104CI-TRIAL-00005120completedPhase 4Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| zoledronic acid | Drug | Zoledronic Acid | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 15 Minute Infusion
- description
- Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3-4 weeks for up to 24 months, over a 15-minute infusion time, but increasing to a 30-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12 weeks
- interventionNames
- Drug: zoledronic acid
- type
- EXPERIMENTAL
- label
- 30 Minute Infusion
- description
- Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3-4 weeks for up to 24 months, over a 30-minute infusion time, but increasing to a 45-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12-weeks.
- interventionNames
- Drug: zoledronic acid
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.