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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
N/A
Open (Enrolling)
Both
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
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 SiteMesa, Arizona  
Research SiteBentonville, Arkansas  
Research SiteAnaheim, California  
Research SiteWashington, District of Columbia  
Research SiteBoca Raton, Florida  
Research SiteAlbany, Georgia  
Research SiteArlington Heights, Illinois  
Research SiteBloomington, Indiana  
Research SiteAmes, Iowa  
Research SiteAshland, Kentucky  
Research SiteBaton Rouge, Louisiana  
Research SiteBangor, Maine  
Research SiteBaltimore, Maryland  
Research SiteBattle Kreek, Michigan  
Research SiteBranson, Missouri  
Research SiteBillings, Montana  
Research SiteGrand Island, Nebraska  
Research SiteLas Vegas, Nevada  
Research SiteBelleville, New Jersey  
Research SiteAlbany, New York  
Research SiteAsheville, North Carolina  
Research SiteBismarck, North Dakota  
Research SiteEnid, Oklahoma  
Research SiteAllentown, Pennsylvania  
Research SiteCharleston, South Carolina  
Research SiteAberdeen, South Dakota  
Research SiteChattanooga, Tennessee  
Research SiteAbington, Virginia  
Research SiteAuburn, Washington  
Research SiteAppleton, Wisconsin