TriangleNCT01345019 · CITED IN SOURCE DOCUMENTS
Denosumab Compared to Zoledronic Acid in the Treatment of Bone Disease in Patients With Multiple Myeloma
An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.
- Phase
- PHASE3
- Status at capture
- COMPLETED
- Registry last update
- 2022-11-08
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.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Participant flow
Baseline characteristics
Time to First On-study Skeletal Related Event
Percentage of Participants With an On-study Skeletal Related Event
Kaplan-Meier Estimate of Percentage of Participants With an On-study Skeletal Related Event
Time to First On-study Skeletal Related Event - Superiority Analysis
Time to First and Subsequent On-Study Skeletal Related Event - Number of Events Per Patient
Time to First and Subsequent On-Study Skeletal Related Event - Number of Events
Overall Survival
Percentage of Participants Who Died
Adverse events
Limitations, agreements, and source contact
Who could take part
- eligibility Criteria
- 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 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
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- 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)
- intervention Names
- Drug: Zoledronic acid
- Drug: Placebo to Denosumab
- Drug: Denosumab (for the open-label treatment phase)
- label
- Zoledronic acid
- type
- ACTIVE_COMPARATOR
- description
- 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)
- intervention Names
- Drug: Denosumab
- Drug: Placebo to zoledronic acid
- Drug: Denosumab (for the open-label treatment phase)
- label
- Denosumab
- type
- EXPERIMENTAL
- interventions
- arm Group Labels
- Denosumab
- description
- Administered by subcutaneous injection once every 4 weeks.
- name
- Denosumab
- other Names
- XGEVA®
- AMG 162
- type
- DRUG
- arm Group Labels
- Zoledronic acid
- description
- Administered by intravenous infusion over 15 minutes once every 4 weeks
- name
- Zoledronic acid
- other Names
- Zometa®
- type
- DRUG
- arm Group Labels
- Zoledronic acid
- description
- Administered by subcutaneous injection once every 4 weeks.
- name
- Placebo to Denosumab
- type
- DRUG
- arm Group Labels
- Denosumab
- description
- Administered by intravenous infusion over 15 minutes once every 4 weeks
- name
- Placebo to zoledronic acid
- type
- DRUG
- arm Group Labels
- Denosumab
- Zoledronic acid
- description
- Administered by subcutaneous injection once every 4 weeks.
- name
- Denosumab (for the open-label treatment phase)
- other Names
- XGEVA®
- AMG 162
- type
- DRUG
Study design
- allocation
- RANDOMIZED
- intervention Model
- PARALLEL
- masking Info
- masking
- QUADRUPLE
- who Masked
- PARTICIPANT
- CARE_PROVIDER
- INVESTIGATOR
- OUTCOMES_ASSESSOR
- primary Purpose
- SUPPORTIVE_CARE
Enrollment
- count
- 1718
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- 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.
- measure
- Time to First On-study Skeletal Related Event
- time Frame
- 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.
- description
- 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.
- measure
- Percentage of Participants With an On-study Skeletal Related Event
- time Frame
- 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.
- description
- 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.
- measure
- Kaplan-Meier Estimate of Percentage of Participants With an On-study Skeletal Related Event
- time Frame
- 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
- description
- 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.
- measure
- Time to First On-study Skeletal Related Event - Superiority Analysis
- time Frame
- 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.
- description
- 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.
- measure
- Time to First and Subsequent On-Study Skeletal Related Event - Number of Events Per Patient
- time Frame
- 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.
- description
- 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.
- measure
- Time to First and Subsequent On-Study Skeletal Related Event - Number of Events
- time Frame
- 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.
- description
- 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.
- measure
- Overall Survival
- time Frame
- 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.
- measure
- Percentage of Participants Who Died
- time Frame
- 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.
Full study description
- 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.
Source references
- references
- citation
- 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
- 29480139
- type
- BACKGROUND
- citation
- Raje 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
- 29429912
- type
- BACKGROUND
- citation
- Huang 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
- 32524500
- type
- BACKGROUND
- citation
- Terpos 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.
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- see Also Links
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- AmgenTrials clinical trials website
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Preserved source evidence · Not medical advice