Therapy With Zoledronic Acid in Patients With Multiple Myeloma Stage I

Novartis

Status and phase: Terminated; Phase 3

Conditions: Multiple Myeloma Stage I

Treatments: Drug: Zoledronic acid; Dietary Supplement: Calcium / Vitamin D

Study type: Interventional

Funder types: Industry

Identifiers

NCT00171925

CZOL446 DE01

Details and patient eligibility

About

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.

Enrollment: 143 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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143 participants in 2 patient groups

Zoledronic acid (ZOL446)

Experimental group

Description:

Participants received intravenous infusion of Zoledronic acid every 4 weeks for 48 weeks, and calcium and Vitamin D daily.

Treatment:

Dietary Supplement: Calcium / Vitamin D

Drug: Zoledronic acid

Control

No Intervention group

Description:

No treatment with study medication.