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A Multiple Myeloma Trial in Patients With Bone Metastases

Primary Purpose

Multiple Myeloma

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
zoledronic acid
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring Z-MAX, multiple myeloma, zoledronic acid, bone metastases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hematology Oncology Specialists
  • Palo Verde Hematology Oncology
  • US Oncology
  • Myeloma Institute For Research Therapy
  • University of Arkansas
  • Pacific Cancer Medical Center
  • Comprehensive Blood and Cancer Center
  • Southbay Oncology Hematology Partners
  • Bay Area Cancer Research Group
  • California Oncology of the Central Valley
  • Dr. Robert P. Brouillard Inc.
  • Antelope Valley Cancer Center
  • Pacific Shores Medical Group
  • North Valley H/O
  • Hematology/Oncology Group of Orange County
  • Desert Hematology Oncology Medical Group
  • Camino Medical Group
  • Oncotherapeutics
  • Greeley Medical Center
  • Florida Cancer Specialists
  • South Florida Oncology Hematology
  • Osceola Cancer Center
  • Miami Cancer Care
  • Pasco Hernado Oncology
  • MetCare Oncology
  • Hematology Oncology Associates PA
  • Hem/Onc Associates of Central Brevard
  • Augusta Oncology Associates
  • Georgia Cancer Specialists
  • Cancer Care Center
  • Hutchinson Clinic, PA
  • Hematology and Oncology Specialists
  • Maine Center for Cancer Medicine - Blood Disorders
  • Center for Cancer and Blood Disorders
  • Oncology Hematology Associates, PA
  • Maryland Oncology-Hematology PA
  • Hematology Oncology Associates of Ohio & Michigan
  • Providence Cancer Center, Clinical Trials Dept
  • Kansas City Cancer Center
  • St. Joseph Oncology, Inc.
  • The Center for Cancer Care and Research
  • Nebraska Methodist Hospital
  • Comprehensive Cancer Centers of Nevada
  • Nevada Cancer Center
  • Center for Cancer & Hematology Disease
  • Central Jersey Oncology Center
  • Hackensack University Medical Center
  • CINJ at Cooper University Hospital
  • New Mexico Cancer Care Associates
  • Hematology Oncology of Western Suffolk
  • New York Presbyterian Hospital
  • Syracuse Hematology/Oncology PC
  • Dayton Oncology & Hematology, PA
  • University of Pennsylvania, Philadelphia
  • Pennsylvania Oncology Associates
  • Berks Oncology and Hematology Associates
  • Hematology & Oncology Associates of RI
  • Roger Williams Hospital Medical Center
  • Charleston Hematology Oncology
  • Baptist Regional Cancer Center
  • Center for Oncology Research & Treatment, PA
  • UT Southwestern Medical Center
  • Joe Arrington Cancer Research and Treatment Center
  • Utah Hematology Oncology
  • Oncology Hematology Associates of Southwest VA
  • Western Washington Oncology
  • Swedish Cancer Institute
  • Fox Valley Hematology Oncology SC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

15 Minute Infusion

30 Minute Infusion

Arm 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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

The Number of Participants With a Significant Increase in Serum Creatinine at 24 Months
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
Median time to event in participants who had a clinically relevant increase in serum creatinine.
Zoledronic Acid Concentrations
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.

Full Information

First Posted
February 22, 2005
Last Updated
June 27, 2011
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00104104
Brief Title
A Multiple Myeloma Trial in Patients With Bone Metastases
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
October 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Z-MAX, multiple myeloma, zoledronic acid, bone metastases

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
179 (Actual)

8. Arms, Groups, and Interventions

Arm Title
15 Minute Infusion
Arm Type
Experimental
Arm 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
Arm Title
30 Minute Infusion
Arm Type
Experimental
Arm 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 Type
Drug
Intervention Name(s)
zoledronic acid
Other Intervention Name(s)
ZOMETA®
Intervention Description
4 mg zoledronic acid in 250 mL of calcium-free solution (i.e., 0.9% sodium chloride or 5% glucose) administered intravenously.
Primary Outcome Measure Information:
Title
The Number of Participants With a Significant Increase in Serum Creatinine at 12 Months
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.
Time Frame
Baseline and 12 Months
Title
The Number of Participants With Disease Progression
Time Frame
24 Months
Secondary Outcome Measure Information:
Title
The Number of Participants With a Significant Increase in Serum Creatinine at 24 Months
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.
Time Frame
Baseline and 24 Months
Title
Time to First Significant Increase in Serum Creatinine
Description
Median time to event in participants who had a clinically relevant increase in serum creatinine.
Time Frame
Up to 24 months
Title
Zoledronic Acid Concentrations
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.
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Chair
Facility Information:
Facility Name
Hematology Oncology Specialists
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Palo Verde Hematology Oncology
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85304
Country
United States
Facility Name
US Oncology
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85710
Country
United States
Facility Name
Myeloma Institute For Research Therapy
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
University of Arkansas
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Pacific Cancer Medical Center
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Comprehensive Blood and Cancer Center
City
Bakersfield
State/Province
California
ZIP/Postal Code
93309
Country
United States
Facility Name
Southbay Oncology Hematology Partners
City
Campbell
State/Province
California
ZIP/Postal Code
95008
Country
United States
Facility Name
Bay Area Cancer Research Group
City
Concord
State/Province
California
ZIP/Postal Code
94520
Country
United States
Facility Name
California Oncology of the Central Valley
City
Fresno
State/Province
California
ZIP/Postal Code
93710
Country
United States
Facility Name
Dr. Robert P. Brouillard Inc.
City
LaJolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Antelope Valley Cancer Center
City
Lancaster
State/Province
California
ZIP/Postal Code
93534
Country
United States
Facility Name
Pacific Shores Medical Group
City
Long Beach
State/Province
California
ZIP/Postal Code
90813
Country
United States
Facility Name
North Valley H/O
City
Mission Hills
State/Province
California
ZIP/Postal Code
91345
Country
United States
Facility Name
Hematology/Oncology Group of Orange County
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Desert Hematology Oncology Medical Group
City
Rancho Mirage
State/Province
California
ZIP/Postal Code
92270
Country
United States
Facility Name
Camino Medical Group
City
Sunnyvale
State/Province
California
ZIP/Postal Code
94086
Country
United States
Facility Name
Oncotherapeutics
City
West Hollywood
State/Province
California
ZIP/Postal Code
90069
Country
United States
Facility Name
Greeley Medical Center
City
Greeley
State/Province
Colorado
ZIP/Postal Code
80631
Country
United States
Facility Name
Florida Cancer Specialists
City
Fort Meyers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Facility Name
South Florida Oncology Hematology
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Osceola Cancer Center
City
Kissimmee
State/Province
Florida
ZIP/Postal Code
34741
Country
United States
Facility Name
Miami Cancer Care
City
Miami
State/Province
Florida
ZIP/Postal Code
33133
Country
United States
Facility Name
Pasco Hernado Oncology
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
Country
United States
Facility Name
MetCare Oncology
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
Hematology Oncology Associates PA
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32501
Country
United States
Facility Name
Hem/Onc Associates of Central Brevard
City
Rockledge
State/Province
Florida
ZIP/Postal Code
32955
Country
United States
Facility Name
Augusta Oncology Associates
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30901
Country
United States
Facility Name
Georgia Cancer Specialists
City
Tucker
State/Province
Georgia
ZIP/Postal Code
30084
Country
United States
Facility Name
Cancer Care Center
City
New Albany
State/Province
Indiana
ZIP/Postal Code
47150
Country
United States
Facility Name
Hutchinson Clinic, PA
City
Hutchinson
State/Province
Kansas
ZIP/Postal Code
67502
Country
United States
Facility Name
Hematology and Oncology Specialists
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
Maine Center for Cancer Medicine - Blood Disorders
City
Scarborough
State/Province
Maine
ZIP/Postal Code
04074
Country
United States
Facility Name
Center for Cancer and Blood Disorders
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Facility Name
Oncology Hematology Associates, PA
City
Clinton
State/Province
Maryland
ZIP/Postal Code
20735
Country
United States
Facility Name
Maryland Oncology-Hematology PA
City
Columbia
State/Province
Maryland
ZIP/Postal Code
21044
Country
United States
Facility Name
Hematology Oncology Associates of Ohio & Michigan
City
Lambertville
State/Province
Michigan
ZIP/Postal Code
48144
Country
United States
Facility Name
Providence Cancer Center, Clinical Trials Dept
City
Southfield
State/Province
Michigan
ZIP/Postal Code
48075
Country
United States
Facility Name
Kansas City Cancer Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64131
Country
United States
Facility Name
St. Joseph Oncology, Inc.
City
St. Joseph
State/Province
Missouri
ZIP/Postal Code
64507
Country
United States
Facility Name
The Center for Cancer Care and Research
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Nebraska Methodist Hospital
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Comprehensive Cancer Centers of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Facility Name
Nevada Cancer Center
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Center for Cancer & Hematology Disease
City
Cherry Hill
State/Province
New Jersey
ZIP/Postal Code
08003
Country
United States
Facility Name
Central Jersey Oncology Center
City
East Brunswick
State/Province
New Jersey
ZIP/Postal Code
08816
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
CINJ at Cooper University Hospital
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08043
Country
United States
Facility Name
New Mexico Cancer Care Associates
City
Santa Fe
State/Province
New Mexico
ZIP/Postal Code
87505
Country
United States
Facility Name
Hematology Oncology of Western Suffolk
City
Bay Shore
State/Province
New York
ZIP/Postal Code
11706
Country
United States
Facility Name
New York Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Syracuse Hematology/Oncology PC
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Dayton Oncology & Hematology, PA
City
Kettering
State/Province
Ohio
ZIP/Postal Code
45409
Country
United States
Facility Name
University of Pennsylvania, Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Pennsylvania Oncology Associates
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19106
Country
United States
Facility Name
Berks Oncology and Hematology Associates
City
West Reading
State/Province
Pennsylvania
ZIP/Postal Code
19611
Country
United States
Facility Name
Hematology & Oncology Associates of RI
City
Cranston
State/Province
Rhode Island
ZIP/Postal Code
02920
Country
United States
Facility Name
Roger Williams Hospital Medical Center
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02908
Country
United States
Facility Name
Charleston Hematology Oncology
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29403
Country
United States
Facility Name
Baptist Regional Cancer Center
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
Center for Oncology Research & Treatment, PA
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
UT Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-9179
Country
United States
Facility Name
Joe Arrington Cancer Research and Treatment Center
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79410
Country
United States
Facility Name
Utah Hematology Oncology
City
Ogden
State/Province
Utah
ZIP/Postal Code
84403
Country
United States
Facility Name
Oncology Hematology Associates of Southwest VA
City
Salem
State/Province
Virginia
ZIP/Postal Code
24153
Country
United States
Facility Name
Western Washington Oncology
City
Lacey
State/Province
Washington
ZIP/Postal Code
98503
Country
United States
Facility Name
Swedish Cancer Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Fox Valley Hematology Oncology SC
City
Appleton
State/Province
Wisconsin
ZIP/Postal Code
54915
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.novartisclinicaltrials.com
Description
Visit NovartisClinicalTrials.com: Pre-qualify for a trial, and view a list of trials and participating study centers.

Learn more about this trial

A Multiple Myeloma Trial in Patients With Bone Metastases

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