Therapy With Zoledronic Acid in Patients With Multiple Myeloma Stage I

Phase 3

Terminated

• Conditions: Multiple Myeloma Stage I
• Interventions: Drug: Zoledronic acid; Dietary Supplement: Calcium / Vitamin D

• Registration Number: NCT00171925
• Lead Sponsor: Novartis Pharmaceuticals

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 the aim of this study to investigate whether zoledronic acid has an influence on the progression of multiple myeloma.

Detailed Description

Not available

Study Timeline

• Study Start: 2000-08
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-15
• Primary Completion: 2008-11
• Study Completion: 2008-11
• Results First Submitted: 2011-01-20
• Results First Submitted QC: 2011-03-25
• Results First Posted: 2011-04-20
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-05
• Last Update Posted: 2012-04-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 143

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Zoledronic acid (ZOL446)	Calcium / Vitamin D	Participants received intravenous infusion of Zoledronic acid every 4 weeks for 48 weeks, and calcium and Vitamin D daily.
Zoledronic acid (ZOL446)	Zoledronic acid	Participants received intravenous infusion of Zoledronic acid every 4 weeks for 48 weeks, and calcium and Vitamin D daily.

Primary Outcome Measures

Name	Time	Method
Days of Progression Free Survival	48 months	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.

Secondary Outcome Measures

Name	Time	Method
Number of Patients With Progression by Individual Criteria	48 months	Number of patients with progression by individual criteria consisting of Progression of disease overall, Skeletal-related events (including pathological fracture, initiation of radiotherapy or surgery on bone, spinal cord compression or Hypercalcemia), Progression to stage II or III according to Salmon \& Durie classification, and unequivocal progression of osteolytic lesion. Patients are counted separately for every type of progression, but only once for Overall Progression.
The Number of Participants With the Development of Skeletal Complications	48 months	* Pathologic fracture: bone fractures that occur spontaneously or from trivial trauma. New vertebral compression fracture defined as a decrease in vertebral height of 25% from baseline; * Spinal cord compression: the impingement of tumor on the spinal cord confirmed by radiography; * Bone Radiotherapy: Bone irradiation to palliate painful lesions, treat or prevent pathologic fractures or spinal cord compression; * Surgery on bone: surgical procedures performed to set, stabilize or prevent pathologic fractures or areas of spinal cord compression; * Hypercalcemia: Corrected serum calcium ≥ 12.0 mg/dl

Trial Locations

Locations (1)

Novartis Investigative Site; 🇩🇪 Berlin, Germany