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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

Phase 3
18 Years
Open (Enrolling)
Cancer, Hematologic Malignancies, Multiple Myeloma, Oncology, Bone Metastases, Multiple Myeloma Bone Lesions

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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

- 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:


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:


Principal Investigator


Investigator Role:

Study Director

Investigator Affiliation:



Switzerland: Swissmedic (Swiss Agency for Therapeutic Products)

Study ID:




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



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