Therapy With Zoledronic Acid in Patients With Multiple Myeloma Stage I
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.
Multiple Myeloma Stage I
Drug: Zoledronic acid
Dietary Supplement: Calcium / Vitamin D
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Therapy With Zoledronic Acid in Patients With Multiple Myeloma Stage I|
- Days of Progression Free Survival [ Time Frame: 48 months ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]
- 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
|Study Start Date:||August 2000|
|Study Completion Date:||November 2008|
|Primary Completion Date:||November 2008 (Final data collection date for primary outcome measure)|
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.