Multiple MyelomaPhase 4NCT00104104
A Multiple Myeloma Trial in Patients With Bone Metastases
A Phase 4 study testing zoledronic acid in people with Multiple Myeloma, run by Novartis Pharmaceuticals at 68 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- zoledronic acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 179 participants
- Where
- 68 sitesUnited States
- Study dates
- Oct 2004to Oct 2007
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
68 sites in 1 country.
68 sites in 1 country
United States68 sites
Pacific Cancer Medical Center
Anaheim, California, 92801
Fox Valley Hematology Oncology SC
Appleton, Wisconsin, 54915
Augusta Oncology Associates
Augusta, Georgia, 30901
Comprehensive Blood and Cancer Center
Bakersfield, California, 93309
Hematology Oncology of Western Suffolk
Bay Shore, New York, 11706
Center for Cancer and Blood Disorders
Bethesda, Maryland, 20817
Southbay Oncology Hematology Partners
Campbell, California, 95008
Charleston Hematology Oncology
Charleston, South Carolina, 29403
Center for Cancer & Hematology Disease
Cherry Hill, New Jersey, 08003
Oncology Hematology Associates, PA
Clinton, Maryland, 20735
Maryland Oncology-Hematology PA
Columbia, Maryland, 21044
Bay Area Cancer Research Group
Concord, California, 94520
Hematology & Oncology Associates of RI
Cranston, Rhode Island, 02920
Center for Oncology Research & Treatment, PA
Dallas, Texas, 75230
UT Southwestern Medical Center
Dallas, Texas, 75390-9179
Central Jersey Oncology Center
East Brunswick, New Jersey, 08816
Florida Cancer Specialists
Fort Meyers, Florida, 33901
California Oncology of the Central Valley
Fresno, California, 93710
Palo Verde Hematology Oncology
Glendale, Arizona, 85304
Greeley Medical Center
Greeley, Colorado, 80631
Hackensack University Medical Center
Hackensack, New Jersey, 07601
South Florida Oncology Hematology
Hollywood, Florida, 33021
Hematology Oncology Specialists
Huntsville, Alabama, 35801
Hutchinson Clinic, PA
Hutchinson, Kansas, 67502
Kansas City Cancer Center
Kansas City, Missouri, 64131
Dayton Oncology & Hematology, PA
Kettering, Ohio, 45409
Osceola Cancer Center
Kissimmee, Florida, 34741
Baptist Regional Cancer Center
Knoxville, Tennessee, 37920
Dr. Robert P. Brouillard Inc.
La Jolla, California, 92037
Western Washington Oncology
Lacey, Washington, 98503
Hematology Oncology Associates of Ohio & Michigan
Lambertville, Michigan, 48144
Antelope Valley Cancer Center
Lancaster, California, 93534
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89109
Nevada Cancer Center
Las Vegas, Nevada, 89128
Myeloma Institute For Research Therapy
Little Rock, Arkansas, 72205
University of Arkansas
Little Rock, Arkansas, 72205
Pacific Shores Medical Group
Long Beach, California, 90813
Joe Arrington Cancer Research and Treatment Center
Lubbock, Texas, 79410
Miami Cancer Care
Miami, Florida, 33133
North Valley H/O
Mission Hills, California, 91345
Cancer Care Center
New Albany, Indiana, 47150
Hematology and Oncology Specialists
New Orleans, Louisiana, 70115
Pasco Hernado Oncology
New Port Richey, Florida, 34652
New York Presbyterian Hospital
New York, New York, 10021
Utah Hematology Oncology
Ogden, Utah, 84403
Nebraska Methodist Hospital
Omaha, Nebraska, 68114
Hematology/Oncology Group of Orange County
Orange, California, 92868
MetCare Oncology
Ormond Beach, Florida, 32174
Hematology Oncology Associates PA
Pensacola, Florida, 32501
University of Pennsylvania, Philadelphia
Philadelphia, Pennsylvania, 19104
Pennsylvania Oncology Associates
Philadelphia, Pennsylvania, 19106
Roger Williams Hospital Medical Center
Providence, Rhode Island, 02908
Desert Hematology Oncology Medical Group
Rancho Mirage, California, 92270
Hem/Onc Associates of Central Brevard
Rockledge, Florida, 32955
St. Joseph Oncology, Inc.
Saint Joseph, Missouri, 64507
Oncology Hematology Associates of Southwest VA
Salem, Virginia, 24153
New Mexico Cancer Care Associates
Santa Fe, New Mexico, 87505
Maine Center for Cancer Medicine - Blood Disorders
Scarborough, Maine, 04074
Swedish Cancer Institute
Seattle, Washington, 98104
Providence Cancer Center, Clinical Trials Dept
Southfield, Michigan, 48075
The Center for Cancer Care and Research
St Louis, Missouri, 63141
Camino Medical Group
Sunnyvale, California, 94086
Syracuse Hematology/Oncology PC
Syracuse, New York, 13210
Georgia Cancer Specialists
Tucker, Georgia, 30084
US Oncology
Tucson, Arizona, 85710
CINJ at Cooper University Hospital
Voorhees Township, New Jersey, 08043
Oncotherapeutics
West Hollywood, California, 90069
Berks Oncology and Hematology Associates
West Reading, Pennsylvania, 19611
About this study
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
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.
- Conditions
- Multiple Myeloma
- Being tested
- zoledronic acid
- Keywords
- Z-MAX, multiple myeloma, zoledronic acid, bone metastases
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
zoledronic acidDrug
Also called ZOMETA®
4 mg zoledronic acid in 250 mL of calcium-free solution (i.e., 0.9% sodium chloride or 5% glucose) administered intravenously.
| Study group | Role | What they receive |
|---|---|---|
| 15 Minute Infusion | Experimental | 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 Receives: Drug: zoledronic acid |
| 30 Minute Infusion | Experimental | 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. Receives: Drug: zoledronic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 12 Months
The Number of Participants With Disease Progression
Measured: 24 Months
Secondary outcomes (3)
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.
Measured: Baseline and 24 Months
Time to First Significant Increase in Serum Creatinine
Median time to event in participants who had a clinically relevant increase in serum creatinine.
Measured: Up to 24 months
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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2005 (estimated)
- Study startOct 2004
- Primary completionOct 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 179 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis Pharmaceuticals, Study chair, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00104104
- Sponsor's protocol ID
- CZOL446EUS97
- Other IDs
- US97
- Status last verified
- Jun 2011
- First submitted
- 22 Feb 2005
- Last updated
- 29 Jun 2011
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00104104
- Acronym / sponsor ID
- CZOL446EUS97
- Conditions
- Multiple Myeloma
- Keywords
- Z-MAX, multiple myeloma, zoledronic acid, bone metastases
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 179 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Oct 2004
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 23 Feb 2005 (estimated)
- Results
- Posted 6 Jun 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 15 Minute Infusion | Experimental | Drug: zoledronic acidParticipants 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 |
| 30 Minute Infusion | Experimental | Drug: zoledronic acidParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| zoledronic acidAlso: ZOMETA®4 mg zoledronic acid in 250 mL of calcium-free solution (i.e., 0.9% sodium chloride or 5% glucose) administered intravenously. | Drug | 15 Minute Infusion, 30 Minute Infusion |
Primary outcome
The Number of Participants With a Significant Increase in Serum Creatinine at 12 Months
Time frame: Baseline and 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
Time frame: 24 Months
3 secondary outcomes
The Number of Participants With a Significant Increase in Serum Creatinine at 24 Months
Time frame: Baseline and 24 Months
Time to First Significant Increase in Serum Creatinine
Time frame: Up to 24 months
Zoledronic Acid Concentrations
Time frame: 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Visit NovartisClinicalTrials.com: Pre-qualify for a trial, and view a list of trials and participating study centers.Link provided by the sponsor.
Related trials for Multiple Myeloma
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study chair
Novartis Pharmaceuticals
68 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing zoledronic acid in people with Multiple Myeloma, run by Novartis Pharmaceuticals at 68 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 68 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jun 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Number of Participants With a Significant Increase in Serum Creatinine at 12 Months (time frame: Baseline and 12 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2011.