Status:
TERMINATED
Therapy With Zoledronic Acid in Patients With Multiple Myeloma Stage I
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Multiple Myeloma Stage I
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 th...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
August 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
143 Patients enrolled
Trial Details
Trial ID
NCT00171925
Start Date
August 1 2000
End Date
November 1 2008
Last Update
April 11 2012
Active Locations (1)
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1
Novartis Investigative Site
Berlin, Germany