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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01345019




Registration number
NCT01345019
Ethics application status
Date submitted
28/04/2011
Date registered
29/04/2011
Date last updated
31/03/2020

Titles & IDs
Public title
Denosumab Compared to Zoledronic Acid in the Treatment of Bone Disease in Patients With Multiple Myeloma
Scientific 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
Secondary ID [1] 0 0
2010-020454-34
Secondary ID [2] 0 0
20090482
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 0 0
Hematologic Malignancies 0 0
Multiple Myeloma 0 0
Oncology 0 0
Bone Metastases 0 0
Multiple Myeloma Bone Lesions 0 0
Condition category
Condition code
Cancer 0 0 0 0
Other cancer types
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Denosumab
Treatment: Drugs - Zoledronic acid
Treatment: Drugs - Placebo to Denosumab
Treatment: Drugs - Placebo to zoledronic acid
Treatment: Drugs - Denosumab (for the open-label treatment phase)

Active Comparator: Zoledronic acid - Zoledronic 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)

Experimental: Denosumab - Denosumab 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)


Treatment: Drugs: Denosumab
Administered by subcutaneous injection once every 4 weeks.

Treatment: Drugs: Zoledronic acid
Administered by intravenous infusion over 15 minutes once every 4 weeks

Treatment: Drugs: Placebo to Denosumab
Administered by subcutaneous injection once every 4 weeks.

Treatment: Drugs: Placebo to zoledronic acid
Administered by intravenous infusion over 15 minutes once every 4 weeks

Treatment: Drugs: Denosumab (for the open-label treatment phase)
Administered by subcutaneous injection once every 4 weeks.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
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.
Primary outcome [2] 0 0
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.
Timepoint [2] 0 0
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.
Primary outcome [3] 0 0
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.
Timepoint [3] 0 0
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 outcome [1] 0 0
Time to First On-study Skeletal Related Event - Superiority Analysis - 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.
Timepoint [1] 0 0
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.
Secondary outcome [2] 0 0
Time to First and Subsequent On-Study Skeletal Related Event - Number of Events Per Patient - 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. Time to a subsequent SRE is defined, similarly to the time to first on-study SRE, as the time interval from the randomization date to the date of a subsequent occurrence of on-study SRE, which had to be at least 21 days after the previous SRE.
A multiple event analysis was used, which accounts for both the absolute number of SREs and for the time between two consecutive events, and therefore, provides a more sensitive assessment of the risk of experiencing an SRE. The average number of events per patient is reported.
Timepoint [2] 0 0
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.
Secondary outcome [3] 0 0
Time to First and Subsequent On-Study Skeletal Related Event - Number of Events - 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. Time to a subsequent SRE is defined, similarly to the time to first on-study SRE, as the time interval from the randomization date to the date of a subsequent occurrence of on-study SRE, which had to be at least 21 days after the previous SRE.
A multiple event analysis was used, which accounts for both the absolute number of SREs and for the time between two consecutive events, and therefore, provides a more sensitive assessment of the risk of experiencing an SRE. The total number of events is reported.
Timepoint [3] 0 0
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.
Secondary outcome [4] 0 0
Overall Survival - Overall survival was defined as the time interval (in days) from the randomization date to the date of death. If a participant was still alive at the primary analysis data cut-off date or was lost to follow-up by the primary analysis data cut-off date, survival time was censored at their last contact date or the primary analysis data cut-off date, whichever was first.
Timepoint [4] 0 0
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.
Secondary outcome [5] 0 0
Percentage of Participants Who Died
Timepoint [5] 0 0
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.

Eligibility
Key inclusion criteria
- 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Supportive Care
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,TAS,VIC
Recruitment hospital [1] 0 0
Research Site - Liverpool
Recruitment hospital [2] 0 0
Research Site - Tweed Heads
Recruitment hospital [3] 0 0
Research Site - Douglas
Recruitment hospital [4] 0 0
Research Site - South Brisbane
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Research Site - Hobart
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Research Site - Clayton
Recruitment hospital [7] 0 0
Research Site - Epping
Recruitment hospital [8] 0 0
Research Site - Malvern
Recruitment hospital [9] 0 0
Research Site - Parkville
Recruitment hospital [10] 0 0
Research Site - Prahran
Recruitment postcode(s) [1] 0 0
2170 - Liverpool
Recruitment postcode(s) [2] 0 0
2485 - Tweed Heads
Recruitment postcode(s) [3] 0 0
4814 - Douglas
Recruitment postcode(s) [4] 0 0
4101 - South Brisbane
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7000 - Hobart
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3168 - Clayton
Recruitment postcode(s) [7] 0 0
3076 - Epping
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3144 - Malvern
Recruitment postcode(s) [9] 0 0
3050 - Parkville
Recruitment postcode(s) [10] 0 0
3181 - Prahran
Recruitment outside Australia
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Catania
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Messina
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Italy
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Italy
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Italy
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Roma
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Italy
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Rozzano MI
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Italy
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Torino
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Italy
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Udine
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Italy
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Vimercate MB
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Japan
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Aichi
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Japan
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Akita
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Japan
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Chiba
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Fukuoka
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Gifu
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Gunma
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Hiroshima
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Hyogo
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Kumamoto
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Kyoto
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Okayama
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Saitama
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Tokushima
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Tokyo
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Japan
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Toyama
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Korea, Republic of
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Anyang
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Korea, Republic of
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Busan
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Korea, Republic of
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Daegu
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Daejeon
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Gwangju
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Korea, Republic of
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Incheon
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Korea, Republic of
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Seoul
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Lithuania
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Kaunas
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Lithuania
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Vilnius
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Malaysia
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Amgen
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Daiichi Sankyo, Inc.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/show/NCT01345019
Trial related presentations / publications
Raje N, Roodman GD, Willenbacher W, Shimizu K, García-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.
Raje N, Terpos E, Willenbacher W, Shimizu K, García-Sanz R, Durie B, Legiec W, Krejcí 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.
Public notes

Contacts
Principal investigator
Name 0 0
MD
Address 0 0
Amgen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications