Clinical trial · Interventional
Therapy With Zoledronic Acid in Patients With Multiple Myeloma Stage I
NCT00171925CI-TRIAL-00006706terminatedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Recruitment in study could not be reached after 8 yrs of recruiting
Summary
Brief summary (as posted)
Multiple myeloma is a disease of B-lymphocytes producing malignant plasma cells. Malignant plasma cells induce osteolytic lesions, which is characteristic for progression of multiple myeloma. It is the aim of this study to investigate whether zoledronic acid has an influence on the progression of multiple myeloma.
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 Stage I | Multiple Myeloma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Calcium / Vitamin D | Dietary Supplement | — | UNRESOLVED |
| Zoledronic acid | Drug | Zoledronic Acid | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Zoledronic acid (ZOL446)
- description
- Participants received intravenous infusion of Zoledronic acid every 4 weeks for 48 weeks, and calcium and Vitamin D daily.
- interventionNames
- Drug: Zoledronic acid
- Dietary Supplement: Calcium / Vitamin D
- type
- NO_INTERVENTION
- label
- Control
- description
- No treatment with study medication.
Primary outcomes (1)
- measure
- Days of Progression Free Survival
- timeFrame
- 48 months
- description
- Progression-free survival was defined as time from date of randomization to death from any cause or one of the following events: * progression to stage II or III according to Salmon \& Durie classification * skeletal related events (pathologic fracture, initiation of radiotherapy or surgery on bone, spinal cord compression or hypercalcemia) * unequivocal progression of osteolytic lesions (at least a 20% increase in the largest diameter of one existing osteolytic lesion which is measured in at least one dimension as 20 mm with conventional techniques), determined radiologically.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria
* Evidence of myeloma according to the criteria of the British Columbia Cancer Agency (for the diagnosis, 2 of the 3 criteria must be met):
* Evidence of paraprotein in the serum or urine
* Bone marrow infiltration with plasma cells which represent more than 10% of the nucleated cells
* Radiologically, at least one osteolytic lesion
* Asymptomatic patients with Stage I (Durie and Salmon) multiple myeloma
Exclusion criteria:
* Patients with more than one osteolytic lesion on conventional skeletal radiography
* Previous treatment with bisphosphonates
* bilirubin \> 2.5 mg/dl
* Abnormal renal function as evidenced by: A calculated creatinine clearance \< 30 ml/minute. Creatinine clearance (CrCl) is calculated using the Cockcroft-Gault formula:
* CrCl= \[140-age(years)\] x weight(kg)/\[72xserumcreatinine(mg/dL)\] X {0.85 for female patients}
* Patients with other malignant diseases or severe concomitant diseases
* Potentially fertile patients who are not using a reliable and appropriate method of contraception
* Pregnancy or breast-feeding
* Participation in another clinical study with an investigational drug within 12 weeks of study entry
* Current active dental problems including infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw (ONJ), of exposed bone in the mouth, or of slow healing after dental procedures.
* Recent (within 6 weeks) or planned dental or jaw surgery (e.g.. extraction, implants)
Other protocol-defined inclusion and exclusion criteria may apply.References
Publications (0)
Data not yet available
No reference posted for this study.