Therapy With Zoledronic Acid in Patients With Multiple Myeloma Stage I
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|ClinicalTrials.gov Identifier: NCT00171925|
Recruitment Status : Terminated (Recruitment in study could not be reached after 8 yrs of recruiting)
First Posted : September 15, 2005
Results First Posted : April 20, 2011
Last Update Posted : April 11, 2012
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma Stage I||Drug: Zoledronic acid Dietary Supplement: Calcium / Vitamin D||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||143 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Therapy With Zoledronic Acid in Patients With Multiple Myeloma Stage I|
|Study Start Date :||August 2000|
|Actual Primary Completion Date :||November 2008|
|Actual Study Completion Date :||November 2008|
Experimental: Zoledronic acid (ZOL446)
Participants received intravenous infusion of Zoledronic acid every 4 weeks for 48 weeks, and calcium and Vitamin D daily.
Drug: Zoledronic acid
Zoledronic acid administered via normal saline intravenous infusion (over 15 minutes) every 4 weeks. Dosage was according to calculated creatinine clearance: patients with baseline creatinine clearance > 60 ml/min received 4 mg; for patients with mild to moderate renal impairment, doses were calculated to achieve the same AUC as that achieved in patients with creatinine clearance of 75 ml/min, assuming target AUC of 0.66 (mg*hr/l).
Dietary Supplement: Calcium / Vitamin D
Patients on zoledronic acid received 500 mg calcium and 400-500 IU vitamin D combination tablet daily.
No Intervention: Control
No treatment with study medication.
- Days of Progression Free Survival [ Time Frame: 48 months ]
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.
- Number of Patients With Progression by Individual Criteria [ Time Frame: 48 months ]Number of patients with progression by individual criteria consisting of Progression of disease overall, Skeletal-related events (including pathological fracture, initiation of radiotherapy or surgery on bone, spinal cord compression or Hypercalcemia), Progression to stage II or III according to Salmon & Durie classification, and unequivocal progression of osteolytic lesion. Patients are counted separately for every type of progression, but only once for Overall Progression.
- The Number of Participants With the Development of Skeletal Complications [ Time Frame: 48 months ]
- Pathologic fracture: bone fractures that occur spontaneously or from trivial trauma. New vertebral compression fracture defined as a decrease in vertebral height of 25% from baseline
- Spinal cord compression: the impingement of tumor on the spinal cord confirmed by radiography
- Bone Radiotherapy: Bone irradiation to palliate painful lesions, treat or prevent pathologic fractures or spinal cord compression
- Surgery on bone: surgical procedures performed to set, stabilize or prevent pathologic fractures or areas of spinal cord compression
- Hypercalcemia: Corrected serum calcium ≥ 12.0 mg/dl
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00171925
|Novartis Investigative Site|
|Study Director:||Novartis Pharmaceuticals||Novartis Pharmaceuticals|