Multiple Myeloma Clinical Trial
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
| Verified date | June 2011 |
| Source | Novartis |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 179 |
| Est. completion date | October 2007 |
| Est. primary completion date | October 2007 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Pacific Cancer Medical Center | Anaheim | California |
| United States | Fox Valley Hematology Oncology SC | Appleton | Wisconsin |
| United States | Augusta Oncology Associates | Augusta | Georgia |
| United States | Comprehensive Blood and Cancer Center | Bakersfield | California |
| United States | Hematology Oncology of Western Suffolk | Bay Shore | New York |
| United States | Center for Cancer and Blood Disorders | Bethesda | Maryland |
| United States | Southbay Oncology Hematology Partners | Campbell | California |
| United States | Charleston Hematology Oncology | Charleston | South Carolina |
| United States | Center for Cancer & Hematology Disease | Cherry Hill | New Jersey |
| United States | Oncology Hematology Associates, PA | Clinton | Maryland |
| United States | Maryland Oncology-Hematology PA | Columbia | Maryland |
| United States | Bay Area Cancer Research Group | Concord | California |
| United States | Hematology & Oncology Associates of RI | Cranston | Rhode Island |
| United States | Center for Oncology Research & Treatment, PA | Dallas | Texas |
| United States | UT Southwestern Medical Center | Dallas | Texas |
| United States | Central Jersey Oncology Center | East Brunswick | New Jersey |
| United States | Florida Cancer Specialists | Fort Meyers | Florida |
| United States | California Oncology of the Central Valley | Fresno | California |
| United States | Palo Verde Hematology Oncology | Glendale | Arizona |
| United States | Greeley Medical Center | Greeley | Colorado |
| United States | Hackensack University Medical Center | Hackensack | New Jersey |
| United States | South Florida Oncology Hematology | Hollywood | Florida |
| United States | Hematology Oncology Specialists | Huntsville | Alabama |
| United States | Hutchinson Clinic, PA | Hutchinson | Kansas |
| United States | Kansas City Cancer Center | Kansas City | Missouri |
| United States | Dayton Oncology & Hematology, PA | Kettering | Ohio |
| United States | Osceola Cancer Center | Kissimmee | Florida |
| United States | Baptist Regional Cancer Center | Knoxville | Tennessee |
| United States | Western Washington Oncology | Lacey | Washington |
| United States | Dr. Robert P. Brouillard Inc. | LaJolla | California |
| United States | Hematology Oncology Associates of Ohio & Michigan | Lambertville | Michigan |
| United States | Antelope Valley Cancer Center | Lancaster | California |
| United States | Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada |
| United States | Nevada Cancer Center | Las Vegas | Nevada |
| United States | Myeloma Institute For Research Therapy | Little Rock | Arkansas |
| United States | University of Arkansas | Little Rock | Arkansas |
| United States | Pacific Shores Medical Group | Long Beach | California |
| United States | Joe Arrington Cancer Research and Treatment Center | Lubbock | Texas |
| United States | Miami Cancer Care | Miami | Florida |
| United States | North Valley H/O | Mission Hills | California |
| United States | Cancer Care Center | New Albany | Indiana |
| United States | Hematology and Oncology Specialists | New Orleans | Louisiana |
| United States | Pasco Hernado Oncology | New Port Richey | Florida |
| United States | New York Presbyterian Hospital | New York | New York |
| United States | Utah Hematology Oncology | Ogden | Utah |
| United States | Nebraska Methodist Hospital | Omaha | Nebraska |
| United States | Hematology/Oncology Group of Orange County | Orange | California |
| United States | MetCare Oncology | Ormond Beach | Florida |
| United States | Hematology Oncology Associates PA | Pensacola | Florida |
| United States | Pennsylvania Oncology Associates | Philadelphia | Pennsylvania |
| United States | University of Pennsylvania, Philadelphia | Philadelphia | Pennsylvania |
| United States | Roger Williams Hospital Medical Center | Providence | Rhode Island |
| United States | Desert Hematology Oncology Medical Group | Rancho Mirage | California |
| United States | Hem/Onc Associates of Central Brevard | Rockledge | Florida |
| United States | Oncology Hematology Associates of Southwest VA | Salem | Virginia |
| United States | New Mexico Cancer Care Associates | Santa Fe | New Mexico |
| United States | Maine Center for Cancer Medicine - Blood Disorders | Scarborough | Maine |
| United States | Swedish Cancer Institute | Seattle | Washington |
| United States | Providence Cancer Center, Clinical Trials Dept | Southfield | Michigan |
| United States | St. Joseph Oncology, Inc. | St. Joseph | Missouri |
| United States | The Center for Cancer Care and Research | St. Louis | Missouri |
| United States | Camino Medical Group | Sunnyvale | California |
| United States | Syracuse Hematology/Oncology PC | Syracuse | New York |
| United States | Georgia Cancer Specialists | Tucker | Georgia |
| United States | US Oncology | Tucson | Arizona |
| United States | CINJ at Cooper University Hospital | Voorhees | New Jersey |
| United States | Oncotherapeutics | West Hollywood | California |
| United States | Berks Oncology and Hematology Associates | West Reading | Pennsylvania |
| Lead Sponsor | Collaborator |
|---|---|
| Novartis Pharmaceuticals |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | Baseline and 12 Months | No |
| Primary | The Number of Participants With Disease Progression | 24 Months | No | |
| Secondary | 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. | Baseline and 24 Months | No |
| Secondary | Time to First Significant Increase in Serum Creatinine | Median time to event in participants who had a clinically relevant increase in serum creatinine. | Up to 24 months | No |
| Secondary | 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. | 24 months | No |
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