Conditions: Multiple Myeloma Stage I
Keywords: Multiple Myeloma Stage I Zoledronic acid Progression
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 143
Healthy volunteers: no

Brief summary:
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.

Detailed description:

Arms:
arm 1: Participants received intravenous infusion of Zoledronic acid every 4 weeks for 48 weeks, and calcium and Vitamin D daily. arm 2: No treatment with study medication.

Interventions: intervention 1: Zoledronic acid intervention 2: Calcium / Vitamin D
Intervention descriptions: intervention 1: 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). intervention 2: Patients on zoledronic acid received 500 mg calcium and 400-500 IU vitamin D combination tablet daily.

Protocol document: