Study Stopped
Recruitment in study could not be reached after 8 yrs of recruiting
Therapy With Zoledronic Acid in Patients With Multiple Myeloma Stage I
1 other identifier
interventional
143
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Aug 2000
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2000
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 15, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2008
CompletedResults Posted
Study results publicly available
April 20, 2011
CompletedApril 11, 2012
April 1, 2012
8.3 years
September 13, 2005
January 20, 2011
April 5, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Days of Progression Free Survival
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.
48 months
Secondary Outcomes (2)
Number of Patients With Progression by Individual Criteria
48 months
The Number of Participants With the Development of Skeletal Complications
48 months
Study Arms (2)
Zoledronic acid (ZOL446)
EXPERIMENTALParticipants received intravenous infusion of Zoledronic acid every 4 weeks for 48 weeks, and calcium and Vitamin D daily.
Control
NO INTERVENTIONNo treatment with study medication.
Interventions
Zoledronic acid administered via normal saline intravenous infusion (over 15 minutes) every 4 weeks. Dosage was according to calculated creatinine clearance: patients with baseline creatinine clearance \> 60 ml/min received 4 mg; for patients with mild to moderate renal impairment, doses were calculated to achieve the same AUC as that achieved in patients with creatinine clearance of 75 ml/min, assuming target AUC of 0.66 (mg\*hr/l).
Patients on zoledronic acid received 500 mg calcium and 400-500 IU vitamin D combination tablet daily.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Novartis Investigative Site
Berlin, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Only exploratory analyses were performed as the trial was terminated early due to lack of obtaining the required sample size. Secondary Outcomes for Quality of Life and Bone Markers not posted due to sparse data.
Results Point of Contact
- Title
- Study Director
- Organization
- Novartis Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 15, 2005
Study Start
August 1, 2000
Primary Completion
November 1, 2008
Study Completion
November 1, 2008
Last Updated
April 11, 2012
Results First Posted
April 20, 2011
Record last verified: 2012-04