A Randomized, Double-Blind, Multicenter Study of Denosumab Compared With Zoledronic Acid (Zometa®) in the Treatment of Bone Disease in Subjects With Newly Diagnosed Multiple Myeloma
18 Years
N/A
Both
Cancer, Hematologic Malignancies, Multiple Myeloma, Oncology, Bone Metastases, Multiple Myeloma Bone Lesions
Trial Information
A Randomized, Double-Blind, Multicenter Study of Denosumab Compared With Zoledronic Acid (Zometa®) in the Treatment of Bone Disease in Subjects With Newly Diagnosed Multiple Myeloma
Inclusion Criteria:
- Adults with newly diagnosed multiple myeloma
- Radiographic evidence of at least 1 bone lesion
- Plan to receive primary frontline anti-myeloma therapies
- Adequate organ function
- Written informed consent
Exclusion Criteria:
- Nonsecretory multiple myeloma (unless baseline serum free light chain level is
elevated)
- Plasma cell leukemia
- POEMS syndrome
- Previous treatment with anti-myeloma therapy
- Prior administration of denosumab
- Prior or current IV bisphosphonate administration
- Use of oral bisphosphonates within the past 1 year
- Prior history or current evidence of osteonecrosis/ osteomyelitis of the jaw
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
Outcome Measure:
Time to the first on-study skeletal related event (SRE) (non-inferiority test)
Outcome Description:
Until approximately 800 subjects have experienced at least one on-study SRE (anticipated to be approximately 48 months).
Outcome Time Frame:
Approximately 48 months
Safety Issue:
No
Principal Investigator
MD
Investigator Role:
Study Director
Investigator Affiliation:
Amgen
Authority:
Switzerland: Swissmedic (Swiss Agency for Therapeutic Products)
Study ID:
20090482
NCT ID:
NCT01345019
Start Date:
March 2012
Completion Date:
July 2016
Related Keywords:
- Cancer
- Hematologic Malignancies
- Multiple Myeloma
- Oncology
- Bone Metastases
- Multiple Myeloma Bone Lesions
- zoledronic acid
- hematologic malignancies
- SRE
- skeletal-related event
- blood cancer
- lytic bone lesions
- bone metastases
- myeloma
- fractures
- spinal cord compression
- radiation to bone
- surgery to bone
- bisphosphonates
- Neoplasms, Plasma Cell
- Paraproteinemias
- Neoplasms
- Neoplasm Metastasis
- Bone Neoplasms
- Bone Marrow Diseases
- Blood Protein Disorders
- Hematologic Diseases
- multiple myeloma
- denosumab
- Neoplastic Processes
- Bone Diseases
- Diphosphonates
- Bone Density Conservation Agents
- Bone Diseases
- Neoplasms
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Neoplasm Metastasis
- Bone Neoplasms
- Bone Marrow Diseases
- Hematologic Neoplasms
Name | Location |
|---|---|
| Research Site | Mesa, Arizona |
| Research Site | Bentonville, Arkansas |
| Research Site | Anaheim, California |
| Research Site | Washington, District of Columbia |
| Research Site | Boca Raton, Florida |
| Research Site | Albany, Georgia |
| Research Site | Arlington Heights, Illinois |
| Research Site | Bloomington, Indiana |
| Research Site | Ames, Iowa |
| Research Site | Ashland, Kentucky |
| Research Site | Baton Rouge, Louisiana |
| Research Site | Bangor, Maine |
| Research Site | Baltimore, Maryland |
| Research Site | Battle Kreek, Michigan |
| Research Site | Branson, Missouri |
| Research Site | Billings, Montana |
| Research Site | Grand Island, Nebraska |
| Research Site | Las Vegas, Nevada |
| Research Site | Belleville, New Jersey |
| Research Site | Albany, New York |
| Research Site | Asheville, North Carolina |
| Research Site | Bismarck, North Dakota |
| Research Site | Enid, Oklahoma |
| Research Site | Allentown, Pennsylvania |
| Research Site | Charleston, South Carolina |
| Research Site | Aberdeen, South Dakota |
| Research Site | Chattanooga, Tennessee |
| Research Site | Abington, Virginia |
| Research Site | Auburn, Washington |
| Research Site | Appleton, Wisconsin |
