Clinical trial NCT01345019: Denosumab Compared to Zoledronic Acid in the Treatment of Bone Disease in Patients With Multiple Myeloma
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cancer
Hematologic Malignancies
Multiple Myeloma
Oncology
Bone Metastases
Multiple Myeloma Bone Lesions
Keywords: 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
Lead sponsor: Amgen
Sponsor class: INDUSTRY
Collaborators: name: Daiichi Sankyo
First posted: 2011-04-29
Enrollment: 1718
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Time to First On-study Skeletal Related Event
timeFrame: 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 With an On-study Skeletal Related Event
timeFrame: 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: Kaplan-Meier Estimate of Percentage of Participants With an On-study Skeletal Related Event
timeFrame: 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:
measure: Time to First On-study Skeletal Related Event - Superiority Analysis
timeFrame: 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: Time to First and Subsequent On-Study Skeletal Related Event - Number of Events Per Patient
timeFrame: 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: Time to First and Subsequent On-Study Skeletal Related Event - Number of Events
timeFrame: 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: Overall Survival
timeFrame: 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
timeFrame: 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.
Other outcomes:
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country: Italy
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country: Italy
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country: Russian Federation
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country: Russian Federation
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country: Russian Federation
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country: Russian Federation
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country: Switzerland
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facility: Research Site
city: Ankara
country: Turkey
facility: Research Site
city: Istanbul
country: Turkey
facility: Research Site
city: Izmir
country: Turkey
facility: Research Site
city: Cherkasy
country: Ukraine
facility: Research Site
city: Dnipropetrovsk
country: Ukraine
facility: Research Site
city: Ivano-Frankivsk
country: Ukraine
facility: Research Site
city: Khmelnitskiy
country: Ukraine
facility: Research Site
city: Kyiv
country: Ukraine
facility: Research Site
city: Lviv
country: Ukraine
facility: Research Site
city: Poltava
country: Ukraine
facility: Research Site
city: Harrow
country: United Kingdom
facility: Research Site
city: Inverness
country: United Kingdom
facility: Research Site
city: Leeds
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: Oxford
country: United Kingdom
facility: Research Site
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
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.
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.
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.
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.