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

This study is currently recruiting participants.
Verified April 2014 by Amgen
Sponsor:
Collaborator:
Daiichi Sankyo Inc.
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01345019
First received: April 28, 2011
Last updated: April 16, 2014
Last verified: April 2014

April 28, 2011
April 16, 2014
May 2012
May 2016   (final data collection date for primary outcome measure)
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).
Time to the first on-study skeletal related event (SRE) (non-inferiority test) [ Time Frame: until approximately 800 subjects have experienced at least one on-study SRE (anticipated to be approximately 48 months) ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01345019 on ClinicalTrials.gov Archive Site
  • 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)
  • Time to the first-and-subsequent SRE (superiority test, using multiple event analysis) [ Time Frame: until approximately 800 subjects have experienced at least one on-study SRE (anticipated to be approximately 48 months) ] [ Designated as safety issue: No ]
  • Time to the first on-study SRE (superiority test) [ Time Frame: until approximately 800 subjects have experienced at least one on-study SRE (anticipated to be approximately 48 months) ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Denosumab Compared to Zoledronic Acid in the Treatment of Bone Disease in Subjects With Multiple Myeloma
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
  • Cancer
  • Hematologic Malignancies
  • Multiple Myeloma
  • Oncology
  • Bone Metastases
  • Multiple Myeloma Bone Lesions
  • Drug: Denosumab
    Denosumab 120 mg SC
  • Drug: Zoledronic acid
    Zoledronic acid 4 mg (adjusted for renal function) IV over at least 15 minutes Q4W (n = 760)
  • 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)
    Intervention: Drug: Zoledronic acid
  • Experimental: Denosumab 120 mg SC and Placebo IV
    Denosumab 120 mg SC + Placebo IV over at least 15 minutes Q4W (n = 760)
    Intervention: Drug: Denosumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1520
October 2018
May 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Documented evidence of multiple myeloma
  • Monoclonal plasma cells in the bone marrow greater than or equal to 10% and/or presence of a biopsy-proven plasmacytoma
  • Monoclonal protein present in the serum and/or urine
  • Radiographic (ie, 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
  • 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
  • More than 1 previous dose of IV bisphosphonate administration
  • Use of oral bisphosphonates with a cumulative exposure of more than 1 year
  • 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
  • Subject is pregnant or breast feeding, or planning to become pregnant within 7 months after end of treatment
  • Subject has known sensitivity to any of the products to be administered during the study (eg, mammalian derived products, calcium or vitamin D)
  • Other criteria may apply
Both
18 Years and older
No
Contact: Amgen Call Center 866-572-6436
United States,   Australia,   Austria,   Bulgaria,   Canada,   Czech Republic,   France,   Germany,   Greece,   Hong Kong,   Hungary,   Ireland,   Italy,   Japan,   Korea, Republic of,   Lithuania,   Malaysia,   New Zealand,   Poland,   Portugal,   Russian Federation,   Singapore,   Slovakia,   Spain,   Switzerland,   Taiwan,   Turkey,   United Kingdom
 
NCT01345019
20090482
Yes
Amgen
Amgen
Daiichi Sankyo Inc.
Study Director: MD Amgen
Amgen
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP