Denosumab Compared to Zoledronic Acid in the Treatment of Bone Disease in Patients With Multiple Myeloma
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
2 other identifiers
interventional
1,718
28 countries
299
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 cancer
Started May 2012
Longer than P75 for phase_3 cancer
299 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 28, 2011
CompletedFirst Posted
Study publicly available on registry
April 29, 2011
CompletedStudy Start
First participant enrolled
May 17, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 19, 2016
CompletedResults Posted
Study results publicly available
March 7, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 29, 2019
CompletedNovember 8, 2022
November 1, 2022
4.2 years
April 28, 2011
January 17, 2018
November 4, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Time to First On-study Skeletal Related Event
A skeletal-related event (SRE) is defined as one of the following: pathologic fracture (vertebral or non-vertebral), radiation therapy to bone (including the use of radioisotopes), surgery to bone, or spinal cord compression. Time to first on-study SRE is defined as the time interval (in days) from the randomization date to the date of first occurrence of on-study SRE. If there was no known event, and the participant was monitored for any one of the four SRE components, time to first on-study SRE was censored at the end of the treatment phase date or the primary analysis data cut-off date, whichever came first.
From randomization until the primary analysis data cut-off date of 19 July 2016 (per protocol); median time on study was 17.6 and 17.3 months in each treatment group respectively.
Percentage of Participants With an On-study Skeletal Related Event
A skeletal-related event (SRE) is defined as one of the following: pathologic fracture (vertebral or non-vertebral), radiation therapy to bone (including the use of radioisotopes), surgery to bone, or spinal cord compression.
From randomization until the primary analysis data cut-off date of 19 July 2016 (per protocol); median time on study was 17.6 and 17.3 months in each treatment group respectively.
Kaplan-Meier Estimate of Percentage of Participants With an On-study Skeletal Related Event
A skeletal-related event (SRE) is defined as one of the following: pathologic fracture (vertebral or non-vertebral), radiation therapy to bone (including the use of radioisotopes), surgery to bone, or spinal cord compression.
From randomization until the primary analysis data cut-off date of 19 July 2016 (per protocol); median time on study was 17.6 and 17.3 months in each treatment group respectively. The Kaplan-Meier estimate at weeks 25, 49 and 109 is reported.
Secondary Outcomes (5)
Time to First On-study Skeletal Related Event - Superiority Analysis
From randomization until the primary analysis data cut-off date of 19 July 2016 (per protocol); median time on study was 17.6 and 17.3 months in each treatment group respectively.
Time to First and Subsequent On-Study Skeletal Related Event - Number of Events Per Patient
From randomization until the primary analysis data cut-off date of 19 July 2016 (per protocol); median time on study was 17.6 and 17.3 months in each treatment group respectively.
Time to First and Subsequent On-Study Skeletal Related Event - Number of Events
From randomization until the primary analysis data cut-off date of 19 July 2016 (per protocol); median time on study was 17.6 and 17.3 months in each treatment group respectively.
Overall Survival
From randomization until the primary analysis data cut-off date of 19 July 2016 (per protocol); median time on study was 17.6 and 17.3 months in each treatment group respectively.
Percentage of Participants Who Died
From randomization until the primary analysis data cut-off date of 19 July 2016 (per protocol); median time on study was 17.6 and 17.3 months in each treatment group respectively.
Study Arms (2)
Zoledronic acid
ACTIVE COMPARATORZoledronic acid 4 mg intravenously plus placebo to denosumab subcutaniously (SC) once every 4 weeks (Q4W) in the double-blind treatment period (Since denosumab was determined to have a positive benefit:risk profile in the primary analysis of the study, per protocol, participants who were still undergoing Q4W scheduled assessments were offered open-label denosumab 120 mg SC Q4W for up to 2 years)
Denosumab
EXPERIMENTALDenosumab 120 mg subcutaniously (SC) plus placebo to zoledronic acid intravenously once every 4 weeks (Q4W) in the double-blind treatment period (Since denosumab was determined to have a positive benefit:risk profile in the primary analysis of the study, per protocol, participants who were still undergoing Q4W scheduled assessments were offered open-label denosumab 120 mg SC Q4W for up to 2 years)
Interventions
Administered by subcutaneous injection once every 4 weeks.
Administered by intravenous infusion over 15 minutes once every 4 weeks
Administered by intravenous infusion over 15 minutes once every 4 weeks
Administered by subcutaneous injection once every 4 weeks.
Eligibility Criteria
You may qualify if:
- Documented evidence of multiple myeloma (per local assessment):
- 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):
- 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
You may not qualify if:
- 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
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
- Daiichi Sankyocollaborator
Study Sites (309)
Research Site
Tucson, Arizona, 85704, United States
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Fayetteville, Arkansas, 72703, United States
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Anaheim, California, 92801, United States
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Campbell, California, 95008, United States
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Encinitas, California, 92024, United States
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Fresno, California, 93720, United States
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Pleasant Hill, California, 94523, United States
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Santa Barbara, California, 93105, United States
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Santa Maria, California, 93454, United States
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Stamford, Connecticut, 06902, United States
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Washington D.C., District of Columbia, 20007, United States
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Washington D.C., District of Columbia, 20010, United States
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Boynton Beach, Florida, 33426, United States
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Boynton Beach, Florida, 33435, United States
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Jacksonville, Florida, 32256, United States
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Columbus, Georgia, 31904, United States
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Savannah, Georgia, 31405, United States
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Chicago, Illinois, 60612, United States
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Joliet, Illinois, 60435, United States
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Maywood, Illinois, 60153, United States
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Niles, Illinois, 60714, United States
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Skokie, Illinois, 60076, United States
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Skokie, Illinois, 60077, United States
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Anderson, Indiana, 46016, United States
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Fort Wayne, Indiana, 46845, United States
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Indianapolis, Indiana, 46202, United States
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Ames, Iowa, 50010, United States
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Iowa City, Iowa, 52242, United States
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Paducah, Kentucky, 42003, United States
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New Orleans, Louisiana, 70121, United States
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Scarborough, Maine, 04074, United States
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Baltimore, Maryland, 21204, United States
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Baltimore, Maryland, 21229, United States
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Baltimore, Maryland, 21237, United States
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Bethesda, Maryland, 20817, United States
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Westminster, Maryland, 21157, United States
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Boston, Massachusetts, 02114, United States
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Boston, Massachusetts, 02215, United States
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Danvers, Massachusetts, 01923, United States
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Fairhaven, Massachusetts, 02719, United States
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Detroit, Michigan, 48201, United States
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Lansing, Michigan, 48910, United States
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Jackson, Mississippi, 39216, United States
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Springfield, Missouri, 65806, United States
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Billings, Montana, 59101, United States
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Lincoln, Nebraska, 68506, United States
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Omaha, Nebraska, 68198, United States
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North Las Vegas, Nevada, 89086, United States
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Hackensack, New Jersey, 07601, United States
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Lake Success, New York, 11042, United States
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New York, New York, 10021, United States
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Rochester, New York, 14621, United States
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Fayetteville, North Carolina, 28304, United States
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Goldsboro, North Carolina, 27534, United States
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High Point, North Carolina, 27262, United States
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Bismarck, North Dakota, 58501, United States
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Oklahoma City, Oklahoma, 73120-8345, United States
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Hershey, Pennsylvania, 17033, United States
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Philadelphia, Pennsylvania, 19106, United States
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Philadelphia, Pennsylvania, 19140, United States
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Philadelphia, Pennsylvania, 19141, United States
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West Reading, Pennsylvania, 19611, United States
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Charleston, South Carolina, 29406, United States
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Charleston, South Carolina, 29414, United States
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Greenville, South Carolina, 29615, United States
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Aberdeen, South Dakota, 57401, United States
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Rapid City, South Dakota, 57701, United States
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Sioux Falls, South Dakota, 57105, United States
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Watertown, South Dakota, 57201, United States
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Memphis, Tennessee, 38120, United States
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Houston, Texas, 77030, United States
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Lubbock, Texas, 79415, United States
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Salt Lake City, Utah, 84106, United States
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Christiansburg, Virginia, 24073, United States
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Spokane, Washington, 99208, United States
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Tacoma, Washington, 98405, United States
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Morgantown, West Virginia, 26506, United States
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Minocqua, Wisconsin, 54548, United States
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Wauwatosa, Wisconsin, 53226, United States
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Liverpool, New South Wales, 2170, Australia
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Tweed Heads, New South Wales, 2485, Australia
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Douglas, Queensland, 4814, Australia
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South Brisbane, Queensland, 4101, Australia
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Hobart, Tasmania, 7000, Australia
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Clayton, Victoria, 3168, Australia
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Epping, Victoria, 3076, Australia
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Malvern, Victoria, 3144, Australia
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Parkville, Victoria, 3050, Australia
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Prahran, Victoria, 3181, Australia
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Graz, 8036, Austria
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Innsbruck, 6020, Austria
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Krems, 3500, Austria
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Salzburg, 5020, Austria
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Vienna, 1090, Austria
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Vienna, 1140, Austria
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Wels, 4600, Austria
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Pleven, 5800, Bulgaria
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Plovdiv, 4002, Bulgaria
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Sofia, 1407, Bulgaria
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Sofia, 1431, Bulgaria
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Sofia, 1606, Bulgaria
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Sofia, 1756, Bulgaria
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Varna, 9010, Bulgaria
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Burnaby, British Columbia, V5G 2X6, Canada
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Winnipeg, Manitoba, R3E 0V9, Canada
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Moncton, New Brunswick, E1C 6Z8, Canada
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St. John's, Newfoundland and Labrador, A1B 3V6, Canada
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Barrie, Ontario, L4M 6M2, Canada
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Newmarket, Ontario, L3Y 2P9, Canada
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Sault Ste. Marie, Ontario, P6B 0A8, Canada
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Toronto, Ontario, M2K 1E1, Canada
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Toronto, Ontario, M3M 0B2, Canada
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Toronto, Ontario, M5B 1W8, Canada
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Toronto, Ontario, M6R 1B5, Canada
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Windsor, Ontario, N8W 2X3, Canada
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Laval, Quebec, H7M 3L9, Canada
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Montreal, Quebec, H1T 2M4, Canada
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Montreal, Quebec, H4J 1C5, Canada
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Québec, Quebec, G1R 2J6, Canada
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Trois-Rivières, Quebec, G8Z 3R9, Canada
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Brno, 625 00, Czechia
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Ostrava-Poruba, 708 52, Czechia
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Pilsen, 304 60, Czechia
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Prague, 100 34, Czechia
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Prague, 128 08, Czechia
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Amiens, 80054, France
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Avignon, 84902, France
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Créteil, 94010, France
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Le Kremlin-Bicêtre, 94270, France
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Le Mans, 72000, France
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Le Mans, 72037, France
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Lille, 59037, France
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Lyon Cédex 3, 69437, France
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Marseille, 13273, France
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Marseille, 13385, France
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Nantes, 44035, France
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Nice, 06202, France
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Paris, 75010, France
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Paris, 75013, France
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Paris, 75015, France
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Paris, 75571, France
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Paris, 75679, France
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Pessac, 33604, France
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Pierre-Bénite, 69495, France
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Pontoise, 95301, France
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Reims, 51056, France
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Rouen, 76038, France
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Saint-Quentin, 02321, France
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Strasbourg, 67000, France
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Villefranche-sur-Saône, 69400, France
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Bonn, 53127, Germany
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Chemnitz, 09113, Germany
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Cologne, 50924, Germany
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Essen, 45239, Germany
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Hamburg, 20246, Germany
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Kassel, 34125, Germany
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Leipzig, 04103, Germany
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Münster, 48149, Germany
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Regensburg, 93049, Germany
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Athens, 11525, Greece
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Athens, 11527, Greece
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Athens, 11528, Greece
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Heraklion, 71110, Greece
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Pátrai, 26500, Greece
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Piraeus, 18537, Greece
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Thessaloniki, 57010, Greece
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Hong Kong, Hong Kong
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New Territories, Hong Kong
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Budapest, 1083, Hungary
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Budapest, 1097, Hungary
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Debrecen, 4032, Hungary
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Győr, 9024, Hungary
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Gyula, 5700, Hungary
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Kaposvár, 7400, Hungary
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Szeged, 6725, Hungary
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Dublin, 24, Ireland
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Dublin, 7, Ireland
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Dublin, 8, Ireland
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Limerick, Ireland
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Tullamore, Ireland
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Ancona, 60126, Italy
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Bari, 70124, Italy
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Brescia, 25125, Italy
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Busto Arsizio, 21052, Italy
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Catania, 95124, Italy
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Florence, 50134, Italy
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Genova, 16132, Italy
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Messina, 98125, Italy
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Milan, 20153, Italy
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Napoli, 80131, Italy
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Napoli, 80136, Italy
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Novara, 28100, Italy
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Palermo, 90146, Italy
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Pescara, 65124, Italy
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Pisa, 56127, Italy
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Roma, 00144, Italy
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Roma, 00161, Italy
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Rozzano MI, 20089, Italy
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Torino, 10126, Italy
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Udine, 33100, Italy
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Vimercate MB, 20871, Italy
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Nagoya, Aichi-ken, 457-8510, Japan
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Akita, Akita, 010-8543, Japan
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Kamogawa-shi, Chiba, 296-8602, Japan
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Fukuoka, Fukuoka, 814-0180, Japan
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Gifu, Gifu, 501-1194, Japan
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Ogaki-shi, Gifu, 503-8502, Japan
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Maebashi, Gunma, 371-8511, Japan
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Shibukawa-shi, Gunma, 377-8511, Japan
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Fukuyama-shi, Hiroshima, 720-0001, Japan
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Kobe, Hyōgo, 650-0047, Japan
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Kumamoto, Kumamoto, 860-0008, Japan
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Kyoto, Kyoto, 603-8151, Japan
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Okayama, Okayama-ken, 701-1192, Japan
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Kawagoe-shi, Saitama, 350-8550, Japan
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Tokushima, Tokushima, 770-8503, Japan
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Shibuya-ku, Tokyo, 150-8935, Japan
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Shinjuku-ku, Tokyo, 162-8655, Japan
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Toyama, Toyama, 930-8550, Japan
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Kaunas, 50009, Lithuania
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Vilnius, LT-08661, Lithuania
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Ipoh, Perak, 30990, Malaysia
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George Town, Pulau Pinang, 10990, Malaysia
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Kuching, Sarawak, 93586, Malaysia
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Ampang, 68000, Malaysia
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Christchurch, 8011, New Zealand
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Grafton, Auckland, 1023, New Zealand
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Legnica, 59-220, Poland
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Lublin, 20-081, Poland
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Słupsk, 76-200, Poland
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Torun, 87-100, Poland
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Warsaw, 02-097, Poland
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Warsaw, 02-776, Poland
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Wroclaw, 53-439, Poland
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Braga, 4710-243, Portugal
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Coimbra, 3000-075, Portugal
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Lisbon, 1169-050, Portugal
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Matosinhos Municipality, 4464-513, Portugal
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Porto, 4200-072, Portugal
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Dzerzhinsk, 606019, Russia
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Moscow, 115478, Russia
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Nizhny Novgorod, 603126, Russia
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Novosibirsk, 630051, Russia
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Penza, 440071, Russia
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Petrozavodsk, 185019, Russia
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Saint Petersburg, 193312, Russia
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Saint Petersburg, 197022, Russia
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Saint Petersburg, 197110, Russia
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Saint Petersburg, 198205, Russia
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Samara, 443099, Russia
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Saratov, 410012, Russia
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Volgograd, 400138, Russia
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Yekaterinburg, 620102, Russia
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Singapore, 119228, Singapore
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Singapore, 169856, Singapore
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Singapore, 308433, Singapore
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Bratislava, 851 07, Slovakia
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Nitra, 950 01, Slovakia
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Nové Zámky, 940 34, Slovakia
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Anyang, 431-070, South Korea
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Busan, 602-739, South Korea
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Daegu, 700-721, South Korea
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Daejeon, 301-721, South Korea
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Gwangju, 519-763, South Korea
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Incheon, 405-760, South Korea
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Seoul, 110-744, South Korea
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Seoul, 120-752, South Korea
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Seoul, 135-710, South Korea
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Seoul, 137-701, South Korea
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Seoul, 158-710, South Korea
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Seville, Andalusia, 41013, Spain
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Palma de Mallorca, Balearic Islands, 07198, Spain
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Donostia / San Sebastian, Basque Country, 20014, Spain
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Salamanca, Castille and León, 37007, Spain
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Badalona, Catalonia, 08916, Spain
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Barcelona, Catalonia, 08036, Spain
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Ourense, Galicia, 32005, Spain
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Valencia, Valencia, 46017, Spain
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Valencia, Valencia, 46026, Spain
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Madrid, 28006, Spain
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Madrid, 28034, Spain
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Chur, 7000, Switzerland
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Zurich, 8032, Switzerland
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Zurich, 8038, Switzerland
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Changhua, 50006, Taiwan
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Kaohsiung City, 83301, Taiwan
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Taichung, 40447, Taiwan
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Taichung, 407, Taiwan
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Tainan, 70403, Taiwan
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Taipei, 10002, Taiwan
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Taoyuan District, 33305, Taiwan
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Adana, 01330, Turkey (Türkiye)
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Ankara, 06100, Turkey (Türkiye)
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Ankara, 06500, Turkey (Türkiye)
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Istanbul, 34452, Turkey (Türkiye)
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Izmir, 35340, Turkey (Türkiye)
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Cherkasy, 18009, Ukraine
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Dnipropetrovsk, 49102, Ukraine
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Ivano-Frankivsk, 76008, Ukraine
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Khmelnitskiy, 29000, Ukraine
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Kyiv, 04107, Ukraine
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Lviv, 79031, Ukraine
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Poltava, 36024, Ukraine
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Harrow, HA1 3UJ, United Kingdom
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Inverness, IV2 3UJ, United Kingdom
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Leeds, LS9 7TF, United Kingdom
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London, NW3 2QG, United Kingdom
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London, SW17 0RE, United Kingdom
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Oxford, OX3 7LJ, United Kingdom
Related Publications (4)
Raje N, Roodman GD, Willenbacher W, Shimizu K, Garcia-Sanz R, Terpos E, Kennedy L, Sabatelli L, Intorcia M, Hechmati G. A cost-effectiveness analysis of denosumab for the prevention of skeletal-related events in patients with multiple myeloma in the United States of America. J Med Econ. 2018 May;21(5):525-536. doi: 10.1080/13696998.2018.1445634. Epub 2018 Mar 5.
PMID: 29480139BACKGROUNDRaje N, Terpos E, Willenbacher W, Shimizu K, Garcia-Sanz R, Durie B, Legiec W, Krejci M, Laribi K, Zhu L, Cheng P, Warner D, Roodman GD. Denosumab versus zoledronic acid in bone disease treatment of newly diagnosed multiple myeloma: an international, double-blind, double-dummy, randomised, controlled, phase 3 study. Lancet Oncol. 2018 Mar;19(3):370-381. doi: 10.1016/S1470-2045(18)30072-X. Epub 2018 Feb 9.
PMID: 29429912BACKGROUNDHuang SY, Yoon SS, Shimizu K, Chng WJ, Chang CS, Wong RS, Gao S, Wang Y, Gordon SW, Glennane A, Min CK. Denosumab Versus Zoledronic Acid in Bone Disease Treatment of Newly Diagnosed Multiple Myeloma: An International, Double-Blind, Randomized Controlled Phase 3 Study-Asian Subgroup Analysis. Adv Ther. 2020 Jul;37(7):3404-3416. doi: 10.1007/s12325-020-01395-x. Epub 2020 Jun 10.
PMID: 32524500BACKGROUNDTerpos E, Raje N, Croucher P, Garcia-Sanz R, Leleu X, Pasteiner W, Wang Y, Glennane A, Canon J, Pawlyn C. Denosumab compared with zoledronic acid on PFS in multiple myeloma: exploratory results of an international phase 3 study. Blood Adv. 2021 Feb 9;5(3):725-736. doi: 10.1182/bloodadvances.2020002378.
PMID: 33560384BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Amgen Inc.
Study Officials
- STUDY DIRECTOR
MD
Amgen
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 28, 2011
First Posted
April 29, 2011
Study Start
May 17, 2012
Primary Completion
July 19, 2016
Study Completion
March 29, 2019
Last Updated
November 8, 2022
Results First Posted
March 7, 2018
Record last verified: 2022-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
- Access Criteria
- Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.