Multiple Myeloma Clinical Trial
— Z-MARKOfficial title:
Bone Marker-directed Dosing of ZOMETA® (Zoledronic Acid) for the Prevention of Skeletal Complications in Patients With Advanced Multiple Myeloma.
| Verified date | May 2021 |
| Source | Novartis |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This study evaluated the effectiveness and safety of a dosing method for zoledronic acid in preventing skeletal complications in multiple myeloma participants who have been on an intravenous (IV) bisphosphonate for about one to two years.
| Status | Completed |
| Enrollment | 121 |
| Est. completion date | April 3, 2012 |
| Est. primary completion date | April 3, 2012 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Confirmed diagnosis of multiple myeloma - Have been on zoledronic acid or pamidronate for 1-2 years and therapy must have been initiated for osteolytic lesion, bone fracture, spinal compression, or osteopenia due to multiple myeloma - Stable renal function Exclusion Criteria: - Known sensitivity to bisphosphonates - Receiving investigational drugs considered not safe for co-administration or have a significant effect on bone turnover - Current active dental problems - Had bone marrow transplant or blood stem cell transplant within 2 months before study entry or planned transplant within 2 months following enrollment Other protocol-defined inclusion/exclusion criteria may apply. |
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Colorado U of Colorado Cancer Center | Aurora | Colorado |
| United States | University of Maryland Greenebaum Cancer Center | Baltimore | Maryland |
| United States | Center for Cancer & Blood Disorders | Bethesda | Maryland |
| United States | Boston VA Healthcare Boston VA | Boston | Massachusetts |
| United States | Dana Farber Cancer Institute Clinical Research Coordinator | Boston | Massachusetts |
| United States | Palm Beach Institute of Hematology Oncology | Boynton Beach | Florida |
| United States | TriValley Cancer Research and Treatment Center | Casa Grande | Arizona |
| United States | Medical Associates, PA | Charleston | South Carolina |
| United States | Oncology - Hematology Associates, PA Oncology Hematology Assoc | Clinton | Maryland |
| United States | Carolina Oncology Specialists, PC | Hickory | North Carolina |
| United States | Wilshire Oncology Medical Group | La Verne | California |
| United States | Regional Hematology-Oncology Associates PC | Langhorne | Pennsylvania |
| United States | Cedars Sinai Medical Center Outpatient Cancer Ctr. (4) | Los Angeles | California |
| United States | Loyola University Medical Center /Cardinal Bernardin Cancer Loyola Univ Med Ctr | Maywood | Illinois |
| United States | Innovative Medical Research of South Florida Innovative Med Research | Miami Shores | Florida |
| United States | West Virginia University Health Research Center Clinical Trial Research Unit | Morgantown | West Virginia |
| United States | Low Country Hematology Oncology Dept of Lowcountry Hem/Onc | Mount Pleasant | South Carolina |
| United States | Palo Alto Medical Foundation Hematology/Oncology | Mountain View | California |
| United States | Peninsula Cancer Institute | Newport News | Virginia |
| United States | Cancer Centers of Florida PA Cancer Centers of Central FL | Ocoee | Florida |
| United States | Northern Utah Cancer Associates Dept.ofNorthernUtahAssoc. | Ogden | Utah |
| United States | Hematology & Oncology Consultants, PC Hematology & Oncology | Omaha | Nebraska |
| United States | Integrated Community Oncology Network Florida Oncology Associates | Orange Park | Florida |
| United States | Temple University Temple University | Philadelphia | Pennsylvania |
| United States | Berkshire Hematology Oncology | Pittsfield | Massachusetts |
| United States | Central Utah Clinic Central Utah Clinic (8) | Provo | Utah |
| United States | Rochester General Hospital / Lipson Cancer Center Lipson Cancer Center | Rochester | New York |
| United States | University of Rochester MC / James P. Wilmot Cancer Center James P. Wilmot Cancer Center | Rochester | New York |
| United States | Oncology Care Medical Associates | San Gabriel | California |
| United States | Santa Clara Valley Health & Hospital System | San Jose | California |
| United States | Swedish Cancer Institute | Seattle | Washington |
| United States | Avera Research Institute | Sioux Falls | South Dakota |
| United States | Somerset Hematology Oncology Associates Somerset Hema Oncol Assoc (2) | Somerset | New Jersey |
| United States | Hematology Oncology PC | Stamford | Connecticut |
| United States | SUNY - Upstate Medical University Div. of Hematology-Oncology | Syracuse | New York |
| United States | N MS Hematology & Oncology | Tupelo | Mississippi |
| United States | Blood and Cancer Center of East Texas | Tyler | Texas |
| United States | East Texas Medical Center Cancer Institute | Tyler | Texas |
| United States | Cooper Cancer Center | Voorhees | New Jersey |
| United States | Washington Hospital Center | Washington | District of Columbia |
| United States | Lexington Oncology Associates | West Columbia | South Carolina |
| United States | Cleveland Clinic Florida | Weston | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Novartis Pharmaceuticals |
United States,
Raje N, Vescio R, Montgomery CW, Badros A, Munshi N, Orlowski R, Hadala JT, Warsi G, Argonza-Aviles E, Ericson SG, Anderson KC. Bone Marker-Directed Dosing of Zoledronic Acid for the Prevention of Skeletal Complications in Patients with Multiple Myeloma: — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage of Participants With =1 SRE at the End of 1 Year on Study | SRE was defined as pathological bone fracture, initiation of radiotherapy or surgery on bone, spinal cord compression, or hypercalcemia of malignancy (HCM). SRE was assessed by centrally read radiographic bone surveys. | 1 year | |
| Secondary | Time to First SRE on Study | The time to first SRE is defined as the date of enrollment to the date of the first occurrence of any SRE on the study. SRE includes pathological fracture, initiation of radiotherapy or surgery on bone, spinal cord compression, or HCM. Participants who drop-out was treated as censored observations. Time to first SRE on the study was assessed by the Kaplan-Meier method. | Up to 2 years | |
| Secondary | Percentage of Participants Who Experienced Pathologic Bone Fracture | Pathologic bone fractures are defined as bone fractures that occur spontaneously or as a result of trivial trauma. | Years 1 and 2 | |
| Secondary | Percentage of Participants Who Experienced Spinal Cord Compression | Spinal cord compression is caused by the impingement of a tumor on the spinal cord and is associated with neurologic impairment and/or back pain. | Years 1 and 2 | |
| Secondary | Percentage of Participants Who Experienced Radiation to Bone | Radiation therapy to bone events includes irradiation of bone to palliate painful lesions, to treat or prevent pathologic fractures, or to treat or prevent spinal cord compression. | Years 1 and 2 | |
| Secondary | Percentage of Participants Who Experienced Surgery to Bone | Surgery to bone events includes surgical procedures that are performed to set or stabilize pathologic fractures or areas of spinal cord compression and surgical procedures that are performed to prevent an imminent pathologic fracture or spinal cord compression. | Years 1 and 2 | |
| Secondary | Percentage of Participants Who Experienced HCM | HCM is defined as corrected serum calcium = 12.0 milligrams per deciliter (mg/dL) (3.00 millimoles per liter [mmol/L]), or a lower level of hypercalcemia that was symptomatic and required active treatment other than rehydration. | Years 1 and 2 | |
| Secondary | Skeletal Related Event (SRE) Rate | The SRE rate for each participant was calculated as the number of SREs/total follow-up time. SRE included pathological bone fracture, initiation of radiotherapy or surgery on bone, spinal cord compression, or HCM. | Years 1 and 2 | |
| Secondary | Change From Baseline in Urinary N-telopeptide of Type 1 Collagen (uNTx) | uNTx is a biomarker used to measure the rate of bone turnover found in urine. | Baseline and Weeks 12, 24, 36, 48, 60, 72, 84 and 100/End of Study (EOS) | |
| Secondary | Time to Death | Time to death was defined as the time from the date of enrollment to the date of death. Participants who dropped out or completed the study were considered censored observations. Time to death was assessed by Kaplan-Meier method. | Up to 2 years |
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