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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



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