Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Daiichi Sankyo Inc.
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01345019
First received: April 28, 2011
Last updated: August 17, 2016
Last verified: August 2016
  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 in the Treatment of Bone Disease in Subjects With Newly Diagnosed Multiple Myeloma

Resource links provided by NLM:


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 50 months ] [ Designated as safety issue: No ]
    Until approximately 676 subjects have experienced at least one on-study SRE (anticipated to be approximately 50 months).


Secondary Outcome Measures:
  • Time to the first-and-subsequent SRE (superiority test, using multiple event analysis) [ Time Frame: Approximately 50 months ] [ Designated as safety issue: No ]
    Until approximately 676 subjects have experienced at least one on-study SRE (anticipated to be approximately 50 months)

  • Time to the first on-study SRE (superiority test) [ Time Frame: Approximately 50 months ] [ Designated as safety issue: No ]
    Until approximately 676 subjects have experienced at least one on-study SRE (anticipated to be approximately 50 months)


Enrollment: 1718
Study Start Date: May 2012
Estimated Study Completion Date: March 2019
Primary Completion Date: July 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 at least 15 minutes Q4W (n = 760)
Drug: Denosumab
Denosumab 120 mg SC

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Documented evidence of multiple myeloma (per local assessment; see section 7.2):
  • Monoclonal plasma cells in the bone marrow greater than or equal to 10% and/or presence of a biopsy-proven plasmacytoma, and
  • Monoclonal protein present in the serum and/or urine
  • Radiographic (X-ray, or computer tomography [CT]) evidence of at least 1 lytic bone lesion (or at least 1 focal lesion per magnetic resonance imaging [MRI])
  • Plan to receive or is receiving primary frontline anti-myeloma therapies
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
  • Age ≥ 18 years
  • Adequate organ function, as defined by the following criteria (per central or local laboratory values; see section 7.2): Serum aspartate aminotransferase (AST) ≤ 2.0 x upper limit of normal (ULN)/ Serum alanine aminotransferase ≤ (ALT) 2.0 x ULN/ Serum total bilirubin ≤ 2.0 x ULN/ Creatinine clearance ≥ 30 mL/min/ Serum calcium or albumin-adjusted serum calcium 2.0 mmol/L (8.0 mg/dL) and 2.9 mmol/L (11.5 mg/dL)
  • Written informed consent before any study-specific procedure is performed

Exclusion Criteria:

  • Nonsecretory multiple myeloma based upon standard M-component criteria (ie, measurable serum/urine M-component) unless the baseline serum free light chain level is elevated
  • POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
  • Plasma cell leukemia
  • More than 30 days of previous treatment (before screening) with anti-myeloma therapy (does not include radiotherapy or a single short course of steroid [ie, less than or equal to the equivalent of dexamethasone 60 mg/day for 4 days]).
  • Planned radiation therapy or surgery to the bone (does not include procedures performed before randomization)
  • Prior administration of denosumab
  • Use of oral bisphosphonates with a cumulative exposure of more than 1 year
  • More than 1 previous dose of IV bisphosphonate administration
  • Prior history or current evidence of osteonecrosis/osteomyelitis of the jaw
  • Active dental or jaw condition which requires oral surgery, including tooth extraction
  • Non-healed dental/oral surgery, including tooth extraction
  • Planned invasive dental procedures
  • Evidence of any of the following conditions per subject self-report or medical chart review: Any prior invasive malignancy within 5 years before randomization/ Any non-invasive malignancy not treated with curative intent or with knownactive disease within 5 years before randomization/ Major surgery or significant traumatic injury occurring within 4 weeks before randomization/ Active infection with Hepatitis B virus or Hepatitis C virus/ Known infection with human immunodeficiency virus (HIV)/ Active infection requiring IV anti-infective therapy
  • Subject is pregnant or breast feeding, or planning to become pregnant within 5 months after end of treatment
  • Female subject of child bearing potential is not willing to use highly effective contraception during treatment and for 5 months after the end of treatment (see section 6.3)
  • Known sensitivity to any of the products to be administered during the study (eg, mammalian derived products, calcium or vitamin D)
  • Subject is receiving or is less than 30 days since ending other experimental device or drug (no marketing authorization for any indication)
  • Subject will not be available for follow-up assessment
  • Any major medical or psychiatric disorder that in the opinion of the investigator, might prevent the subject from completing the study or interfere with the interpretation of the study results
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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Dnipropetrovsk, Ukraine, 49102
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Ivano-Frankivsk, Ukraine, 76008
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Khmelnitskiy, Ukraine, 29000
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Kyiv, Ukraine, 04107
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Lviv, Ukraine, 79031
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Poltava, Ukraine, 36024
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Inverness, United Kingdom, IV2 3UJ
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London, United Kingdom, NW3 2QG
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London, United Kingdom, SW17 0RE
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Oxford, United Kingdom, OX3 7LJ
Sponsors and Collaborators
Amgen
Daiichi Sankyo Inc.
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01345019     History of Changes
Other Study ID Numbers: 20090482 
Study First Received: April 28, 2011
Last Updated: August 17, 2016
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: 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)
Ukraine: Ministry of Health
Ukraine: State Pharmacological Center - Ministry of Health
Slovakia: State Institute for Drug Control
Lithuania: Bioethics Committee
Lithuania: State Medicine Control Agency - Ministry of Health

Keywords provided by Amgen:
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

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasm Metastasis
Neoplasms
Bone 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
Musculoskeletal Diseases
Zoledronic acid
Diphosphonates
Bone Density Conservation Agents
Denosumab
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on December 09, 2016