A Multiple Myeloma Trial in Patients With Bone Metastases
This study has been completed.
Sponsor:
Novartis Pharmaceuticals
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00104104
First received: February 22, 2005
Last updated: June 27, 2011
Last verified: June 2011
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Purpose
The purpose of this trial is to study the safety of treating patients with multiple myeloma and at least one bone lesion with zoledronic acid 4mg intravenously (IV) every 3 - 4 weeks for 2 years. Patients will receive a zoledronic acid infusion for 15 minutes or 30 minutes.
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Myeloma |
Drug: zoledronic acid |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Multicenter,Open Label, Randomized Trial Evaluating the Duration of Infusion of Zoledronic Acid 4 mg IV in Multiple Myeloma Patients With Bone Metastases |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- The Number of Participants With a Significant Increase in Serum Creatinine at 12 Months [ Time Frame: Baseline and 12 Months ] [ Designated as safety issue: No ]The primary renal safety endpoint was the number of participants with a clinically relevant increase in serum creatinine at 12 months. Serum creatinine was determined prior to each zoledronic acid infusion for all Participants and was considered to be significantly increased if there was an increase of 0.5 mg/dL or more or a doubling of the baseline serum creatinine value.
- The Number of Participants With Disease Progression [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- The Number of Participants With a Significant Increase in Serum Creatinine at 24 Months [ Time Frame: Baseline and 24 Months ] [ Designated as safety issue: No ]Serum Creatinine was considered to be significantly increased if there was an increase of 0.5 mg/dL or more or a doubling of the baseline serum creatinine value.
- Time to First Significant Increase in Serum Creatinine [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]Median time to event in participants who had a clinically relevant increase in serum creatinine.
- Zoledronic Acid Concentrations [ Time Frame: 24 months ] [ Designated as safety issue: No ]Samples for drug concentration analysis were drawn at 10 and 15 minutes into the infusion for participants in the 15-minute infusion group and at 25 and 30 minutes into the infusion for patients in the 30-minute infusion group. The mean and median zoledronic acid concentrations were greater in the 15-minute group than in the 30-minute group at both sampling timepoints.
| Enrollment: | 179 |
| Study Start Date: | October 2004 |
| Study Completion Date: | October 2007 |
| Primary Completion Date: | October 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 15 Minute Infusion
Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3-4 weeks for up to 24 months, over a 15-minute infusion time, but increasing to a 30-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12 weeks
|
Drug: zoledronic acid
4 mg zoledronic acid in 250 mL of calcium-free solution (i.e., 0.9% sodium chloride or 5% glucose) administered intravenously.
Other Name: ZOMETA®
|
|
Experimental: 30 Minute Infusion
Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3-4 weeks for up to 24 months, over a 30-minute infusion time, but increasing to a 45-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12-weeks.
|
Drug: zoledronic acid
4 mg zoledronic acid in 250 mL of calcium-free solution (i.e., 0.9% sodium chloride or 5% glucose) administered intravenously.
Other Name: ZOMETA®
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients 18 years of age or older
- Confirmed diagnosis of Multiple Myeloma
- Stable renal function defined as two serum creatinine determinations of < 3 mg/dL
- Calculated creatinine clearance of greater than or equal to 30 mL/min
- ECOG Performance Status of 0 or 1
- Life expectancy of greater than or equal to 9 months
- If the patient is of child-bearing potential, a negative pregnancy test is required at screening, while postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential.
- Ability to comply with trial requirements and give informed consent.
Exclusion Criteria:
- IV Bisphosphonate therapy for more than 3 years.
- Patients with a diagnosis of amyloidosis.
- Known hypersensitivity to zoledronic acid or other bisphosphonates
- Pregnant patients or lactating patients.
- Women of childbearing potential not on a medically recognized form of contraception
- Patients with uncontrolled cardiovascular disease, hypertension, and Type 2 diabetes mellitus.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00104104
Show 68 Study Locations
Show 68 Study LocationsSponsors and Collaborators
Novartis Pharmaceuticals
Investigators
| Study Chair: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
More Information
Additional Information:
No publications provided
| Responsible Party: | External Affairs, Novartis Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00104104 History of Changes |
| Other Study ID Numbers: | CZOL446EUS97, US97 |
| Study First Received: | February 22, 2005 |
| Results First Received: | January 6, 2011 |
| Last Updated: | June 27, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Novartis:
|
Z-MAX, multiple myeloma, zoledronic acid, bone metastases |
Additional relevant MeSH terms:
|
Multiple Myeloma Neoplasms, Plasma Cell Neoplasm Metastasis Bone Neoplasms Bone Marrow Diseases Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders |
Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases Neoplastic Processes Pathologic Processes Neoplasms by Site Bone Diseases Musculoskeletal Diseases Zoledronic acid Diphosphonates Bone Density Conservation Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013