NCT00104104 · REGISTRY CONDITION SEARCH

A Multiple Myeloma Trial in Patients With Bone Metastases

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE4
Status at capture: COMPLETED
Registry last update: 2011-06-29

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

The Number of Participants With a Significant Increase in Serum Creatinine at 12 Months

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outcome · POSTED

The Number of Participants With a Significant Increase in Serum Creatinine at 24 Months

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outcome · POSTED

Time to First Significant Increase in Serum Creatinine

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outcome · POSTED

Zoledronic Acid Concentrations

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outcome · POSTED

The Number of Participants With Disease Progression

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility 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.
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
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
intervention Names
Drug: zoledronic acid
label
15 Minute Infusion
type
EXPERIMENTAL
description
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.
intervention Names
Drug: zoledronic acid
label
30 Minute Infusion
type
EXPERIMENTAL

interventions

arm Group Labels
15 Minute Infusion
30 Minute Infusion
description
4 mg zoledronic acid in 250 mL of calcium-free solution (i.e., 0.9% sodium chloride or 5% glucose) administered intravenously.
name
zoledronic acid
other Names
ZOMETA®
type
DRUG

Study design

allocation

RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 179
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
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.
measure
The Number of Participants With a Significant Increase in Serum Creatinine at 12 Months
time Frame
Baseline and 12 Months
measure
The Number of Participants With Disease Progression
time Frame
24 Months

secondary Outcomes

description
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.
measure
The Number of Participants With a Significant Increase in Serum Creatinine at 24 Months
time Frame
Baseline and 24 Months
description
Median time to event in participants who had a clinically relevant increase in serum creatinine.
measure
Time to First Significant Increase in Serum Creatinine
time Frame
Up to 24 months
description
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.
measure
Zoledronic Acid Concentrations
time Frame
24 months

Full study description

brief Summary: 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.

Source references