Know Cancer

forgot password

Therapy With Zoledronic Acid in Patients With Multiple Myeloma Stage I

Phase 3
18 Years
Not Enrolling
Multiple Myeloma Stage I

Thank you

Trial Information

Therapy With Zoledronic Acid in Patients With Multiple Myeloma Stage I

Inclusion 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

- 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

- 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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Days of Progression Free Survival

Outcome Description:

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.

Outcome Time Frame:

48 months

Safety Issue:


Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals


United States: Institutional Review Board

Study ID:

CZOL446 DE01



Start Date:

August 2000

Completion Date:

November 2008

Related Keywords:

  • Multiple Myeloma Stage I
  • Multiple Myeloma
  • Stage I
  • Zoledronic acid
  • Progression
  • Multiple Myeloma
  • Neoplasms, Plasma Cell