Therapy With Zoledronic Acid in Patients With Multiple Myeloma Stage I
Condition: Multiple Myeloma Stage I
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: Zoledronic acid; Calcium / Vitamin D
Intervention description: 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).; Patients on zoledronic acid received 500 mg calcium and 400-500 IU vitamin D combination tablet daily.
Intervention MeSH terms: Vitamin D; Zoledronic Acid; Calcium
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 143.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Multiple Myeloma; Stage I; Zoledronic acid; Progression

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.
    

Eligibility criteria:

        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.