Clinical trial NCT00622505: Zoledronic Acid Treatment (Every 4 or 12 Weeks) to Prevent Skeletal Complications in Advanced Multiple Myeloma Participants
Official title: Bone Marker-directed Dosing of ZOMETA® (Zoledronic Acid) for the Prevention of Skeletal Complications in Patients With Advanced Multiple Myeloma.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Multiple Myeloma
Keywords: Multiple myeloma
zoledronic acid
skeletal complications
bone
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2008-02-25
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants With ≥1 SRE at the End of 1 Year on Study
timeFrame: 1 year
Secondary outcomes:
measure: Time to First SRE on Study
timeFrame: Up to 2 years
measure: Percentage of Participants Who Experienced Pathologic Bone Fracture
timeFrame: Years 1 and 2
measure: Percentage of Participants Who Experienced Spinal Cord Compression
timeFrame: Years 1 and 2
measure: Percentage of Participants Who Experienced Radiation to Bone
timeFrame: Years 1 and 2
measure: Percentage of Participants Who Experienced Surgery to Bone
timeFrame: Years 1 and 2
measure: Percentage of Participants Who Experienced HCM
timeFrame: Years 1 and 2
measure: Skeletal Related Event (SRE) Rate
timeFrame: Years 1 and 2
measure: Change From Baseline in Urinary N-telopeptide of Type 1 Collagen (uNTx)
timeFrame: Baseline and Weeks 12, 24, 36, 48, 60, 72, 84 and 100/End of Study (EOS)
measure: Time to Death
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Casa Grande
country: United States
facility: TriValley Cancer Research and Treatment Center
state: Arizona
city: La Verne
country: United States
facility: Wilshire Oncology Medical Group
state: California
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center Outpatient Cancer Ctr. (4)
state: California
city: Mountain View
country: United States
facility: Palo Alto Medical Foundation Hematology/Oncology
state: California
city: San Gabriel
country: United States
facility: Oncology Care Medical Associates
state: California
city: San Jose
country: United States
facility: Santa Clara Valley Health & Hospital System
state: California
city: Aurora
country: United States
facility: University of Colorado U of Colorado Cancer Center
state: Colorado
city: Stamford
country: United States
facility: Hematology Oncology PC
state: Connecticut
city: Washington
country: United States
facility: Washington Hospital Center
state: District of Columbia
city: Boynton Beach
country: United States
facility: Palm Beach Institute of Hematology Oncology
state: Florida
city: Miami Shores
country: United States
facility: Innovative Medical Research of South Florida Innovative Med Research
state: Florida
city: Ocoee
country: United States
facility: Cancer Centers of Florida PA Cancer Centers of Central FL
state: Florida
city: Orange Park
country: United States
facility: Integrated Community Oncology Network Florida Oncology Associates
state: Florida
city: Weston
country: United States
facility: Cleveland Clinic Florida
state: Florida
city: Maywood
country: United States
facility: Loyola University Medical Center /Cardinal Bernardin Cancer Loyola Univ Med Ctr
state: Illinois
city: Baltimore
country: United States
facility: University of Maryland Greenebaum Cancer Center
state: Maryland
city: Bethesda
country: United States
facility: Center for Cancer & Blood Disorders
state: Maryland
city: Clinton
country: United States
facility: Oncology - Hematology Associates, PA Oncology Hematology Assoc
state: Maryland
city: Boston
country: United States
facility: Dana Farber Cancer Institute Clinical Research Coordinator
state: Massachusetts
city: Boston
country: United States
facility: Boston VA Healthcare Boston VA
state: Massachusetts
city: Pittsfield
country: United States
facility: Berkshire Hematology Oncology
state: Massachusetts
city: Tupelo
country: United States
facility: N MS Hematology & Oncology
state: Mississippi
city: Omaha
country: United States
facility: Hematology & Oncology Consultants, PC Hematology & Oncology
state: Nebraska
city: Somerset
country: United States
facility: Somerset Hematology Oncology Associates Somerset Hema Oncol Assoc (2)
state: New Jersey
city: Voorhees
country: United States
facility: Cooper Cancer Center
state: New Jersey
city: Rochester
country: United States
facility: Rochester General Hospital / Lipson Cancer Center Lipson Cancer Center
state: New York
city: Rochester
country: United States
facility: University of Rochester MC / James P. Wilmot Cancer Center James P. Wilmot Cancer Center
state: New York
city: Syracuse
country: United States
facility: SUNY - Upstate Medical University Div. of Hematology-Oncology
state: New York
city: Hickory
country: United States
facility: Carolina Oncology Specialists, PC
state: North Carolina
city: Langhorne
country: United States
facility: Regional Hematology-Oncology Associates PC
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University Temple University
state: Pennsylvania
city: Charleston
country: United States
facility: Medical Associates, PA
state: South Carolina
city: Mount Pleasant
country: United States
facility: Low Country Hematology Oncology Dept of Lowcountry Hem/Onc
state: South Carolina
city: West Columbia
country: United States
facility: Lexington Oncology Associates
state: South Carolina
city: Sioux Falls
country: United States
facility: Avera Research Institute
state: South Dakota
city: Tyler
country: United States
facility: Blood and Cancer Center of East Texas
state: Texas
city: Tyler
country: United States
facility: East Texas Medical Center Cancer Institute
state: Texas
city: Ogden
country: United States
facility: Northern Utah Cancer Associates Dept.ofNorthernUtahAssoc.
state: Utah
city: Provo
country: United States
facility: Central Utah Clinic Central Utah Clinic (8)
state: Utah
city: Newport News
country: United States
facility: Peninsula Cancer Institute
state: Virginia
city: Seattle
country: United States
facility: Swedish Cancer Institute
state: Washington
city: Morgantown
country: United States
facility: West Virginia University Health Research Center Clinical Trial Research Unit
state: West Virginia
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: 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: Results of the Z-MARK Study. Clin Cancer Res. 2016 Mar 15;22(6):1378-84. doi: 10.1158/1078-0432.CCR-15-1864. Epub 2015 Dec 7.