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Denosumab Compared to Zoledronic Acid in the Treatment of Bone Disease in Subjects With Multiple Myeloma

This study is currently recruiting participants.
Verified May 2013 by Amgen
Sponsor:
Collaborator:
Daiichi Sankyo Inc.
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01345019
First received: April 28, 2011
Last updated: May 6, 2013
Last verified: May 2013
History of Changes
  Purpose

The purpose of this study is to determine if denosumab is non-inferior to zoledronic acid in the treatment of bone disease from multiple myeloma.


Condition Intervention Phase
Cancer
Hematologic Malignancies
Multiple Myeloma
Oncology
Bone Metastases
Multiple Myeloma Bone Lesions
 Drug: Denosumab
Drug: Zoledronic acid
 Phase 3

Study Type: 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
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Amgen:

Primary Outcome Measures:
  • Time to the first on-study skeletal related event (SRE) (non-inferiority test) [ Time Frame: Approximately 48 months ] [ Designated as safety issue: No ]
    Until approximately 800 subjects have experienced at least one on-study SRE (anticipated to be approximately 48 months).


Secondary Outcome Measures:
  • Time to the first-and-subsequent SRE (superiority test, using multiple event analysis) [ Time Frame: Approximately 48 months ] [ Designated as safety issue: No ]
    Until approximately 800 subjects have experienced at least one on-study SRE (anticipated to be approximately 48 months)

  • Time to the first on-study SRE (superiority test) [ Time Frame: Approximately 48 months ] [ Designated as safety issue: No ]
    Until approximately 800 subjects have experienced at least one on-study SRE (anticipated to be approximately 48 months)


Estimated Enrollment: 1520
Study Start Date: March 2012
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Zoledronic acid 4 mg IV and Placebo SC
Zoledronic acid 4 mg (adjusted for renal function) IV over at least 15 minutes + Placebo SC Q4W (n = 760)
 Drug: Zoledronic acid
Zoledronic acid 4 mg (adjusted for renal function) IV over at least 15 minutes Q4W (n = 760)
Experimental: Denosumab 120 mg SC and Placebo IV
Denosumab 120 mg SC + Placebo IV over 15 minutes Q4W (n = 760)
 Drug: Denosumab
Denosumab 120 mg SC

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01345019

Contacts
Contact: Amgen Call Center 866-572-6436

  Show 246 Study Locations
Sponsors and Collaborators
Amgen
Daiichi Sankyo Inc.
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
AmgenTrials clinical trials website  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01345019     History of Changes
Other Study ID Numbers: 20090482
Study First Received: April 28, 2011
Last Updated: May 6, 2013
Health Authority: Switzerland: Swissmedic (Swiss Agency for Therapeutic Products)
Taiwan: Taiwan Provincial Department of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration
Australia: Therapeutic Goods Administration
Czech Republic: State Institute for Drug Control
France and Sweden: European Medicines Agency
France: Ministry of Health
Germany: Federal Institute for Drugs and Medical Devices
Greece: Ministry of Health & Social Solidarity, National Organization for Medicines
Hungary: National Institute of Pharmacy
Ireland: Irish Medicines Board
Italy: Ministry of Health
Japan: Pharmaceuticals and Medical Devices Evaluation Center
New Zealand: Medicines and Medical Devices Safety Authority
Poland: Central Ethics Committee
Poland: Ministry of Health
Portugal: Instituto Nacional da Farmácia e do Medicamento (INFARMED)
Portugal: National Institute of Pharmacy and Medicines
Spain: Spanish Agency of Medicines
Austria: Agency for Health and Food Safety
Canada: Ethics Review Committee
Canada: Health Canada
Bulgaria: Bulgarian Drug Agency
Bulgaria: Ministry of Health
Russia: Ethics Committee
Russia: Pharmacological Committee, Ministry of Health
Russia: FSI Scientific Center of Expertise of Medical Application
Turkey: Ethics Committee
Turkey: Ministry of Health
Hong Kong: Ethics Committee
Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee
Malaysia: Ministry of Health
Singapore: Clinical Trials & Epidemiology Research Unit (CTERU)
Singapore: Domain Specific Review Boards
Singapore: Health Sciences Authority
South Korea: Institutional Review Board
South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Amgen:
myeloma
multiple myeloma
zoledronic acid
hematologic malignancies
SRE
skeletal-related event
blood cancer
lytic bone lesions
bone metastases
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
denosumab
Neoplastic Processes
Bone Diseases
Diphosphonates
Bone Density Conservation Agents

Additional relevant MeSH terms:
Multiple Myeloma
Bone Diseases
Neoplasms
Neoplasms, Plasma Cell
Neoplasm Metastasis
Bone Neoplasms
Bone Marrow Diseases
Hematologic Neoplasms
Musculoskeletal Diseases
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
 Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Neoplastic Processes
Pathologic Processes
Neoplasms by Site
Zoledronic acid
Diphosphonates
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013