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Therapy With Zoledronic Acid in Patients With Multiple Myeloma Stage I

Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Multiple Myeloma Stage I

Intervention: Zoledronic acid (Drug); Calcium / Vitamin D (Dietary Supplement)

Phase: Phase 3

Status: Terminated

Sponsored by: Novartis Pharmaceuticals

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis Pharmaceuticals

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.

Clinical Details

Official title: Therapy With Zoledronic Acid in Patients With Multiple Myeloma Stage I

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

Primary outcome: Days of Progression Free Survival

Secondary outcome:

Number of Patients With Progression by Individual Criteria

The Number of Participants With the Development of Skeletal Complications

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Novartis Investigative Site, Berlin, Germany
Additional Information

Starting date: August 2000
Last updated: April 5, 2012

Page last updated: August 23, 2015

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