Back to results

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

Primary Purpose

Cancer, Hematologic Malignancies, Multiple Myeloma

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Denosumab

Zoledronic acid

Placebo to Denosumab

Placebo to zoledronic acid

Denosumab (for the open-label treatment phase)

About this trial

This is an interventional supportive care trial for Cancer focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Zoledronic acid

Denosumab

Arm 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)

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)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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.

Time to First and Subsequent On-Study Skeletal Related Event - Number of Events

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.

Percentage of Participants Who Died

Full Information

NCT ID

NCT01345019

First Posted

April 28, 2011

Last Updated

November 4, 2022

Sponsor

Amgen

Collaborators

Daiichi Sankyo, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01345019

Brief Title

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

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Completed

Study Start Date

May 17, 2012 (Actual)

Primary Completion Date

July 19, 2016 (Actual)

Study Completion Date

March 29, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Amgen

Collaborators

Daiichi Sankyo, Inc.

4. Oversight

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

1718 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Zoledronic acid

Arm Type

Active Comparator

Arm Description

Arm Title

Denosumab

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Denosumab

Other Intervention Name(s)

XGEVA®, AMG 162

Intervention Description

Administered by subcutaneous injection once every 4 weeks.

Intervention Type

Drug

Intervention Name(s)

Zoledronic acid

Other Intervention Name(s)

Zometa®

Intervention Description

Administered by intravenous infusion over 15 minutes once every 4 weeks

Intervention Type

Drug

Intervention Name(s)

Placebo to Denosumab

Intervention Description

Administered by subcutaneous injection once every 4 weeks.

Intervention Type

Drug

Intervention Name(s)

Placebo to zoledronic acid

Intervention Description

Administered by intravenous infusion over 15 minutes once every 4 weeks

Intervention Type

Drug

Intervention Name(s)

Denosumab (for the open-label treatment phase)

Other Intervention Name(s)

XGEVA®, AMG 162

Intervention Description

Administered by subcutaneous injection once every 4 weeks.

Primary Outcome Measure Information:

Title

Time to First On-study Skeletal Related Event

Description

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.

Title

Percentage of Participants With an On-study Skeletal Related Event

Description

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.

Title

Kaplan-Meier Estimate of Percentage of Participants With an On-study Skeletal Related Event

Description

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 Outcome Measure Information:

Title

Time to First On-study Skeletal Related Event - Superiority Analysis

Description

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.

Title

Time to First and Subsequent On-Study Skeletal Related Event - Number of Events Per Patient

Description

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.

Title

Time to First and Subsequent On-Study Skeletal Related Event - Number of Events

Description

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.

Title

Overall Survival

Description

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.

Title

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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Organizational Affiliation

Amgen

Official's Role

Study Director

Facility Information:

Facility Name

Research Site

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85704

Country

United States

Facility Name

Research Site

City

Fayetteville

State/Province

Arkansas

ZIP/Postal Code

72703

Country

United States

Facility Name

Research Site

City

Anaheim

State/Province

California

ZIP/Postal Code

92801

Country

United States

Facility Name

Research Site

City

Campbell

State/Province

California

ZIP/Postal Code

95008

Country

United States

Facility Name

Research Site

City

Encinitas

State/Province

California

ZIP/Postal Code

92024

Country

United States

Facility Name

Research Site

City

Fresno

State/Province

California

ZIP/Postal Code

93720

Country

United States

Facility Name

Research Site

City

Pleasant Hill

State/Province

California

ZIP/Postal Code

94523

Country

United States

Facility Name

Research Site

City

Santa Barbara

State/Province

California

ZIP/Postal Code

93105

Country

United States

Facility Name

Research Site

City

Santa Maria

State/Province

California

ZIP/Postal Code

93454

Country

United States

Facility Name

Research Site

City

Stamford

State/Province

Connecticut

ZIP/Postal Code

06902

Country

United States

Facility Name

Research Site

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20007

Country

United States

Facility Name

Research Site

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20010

Country

United States

Facility Name

Research Site

City

Boynton Beach

State/Province

Florida

ZIP/Postal Code

33426

Country

United States

Facility Name

Research Site

City

Boynton Beach

State/Province

Florida

ZIP/Postal Code

33435

Country

United States

Facility Name

Research Site

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32256

Country

United States

Facility Name

Research Site

City

Columbus

State/Province

Georgia

ZIP/Postal Code

31904

Country

United States

Facility Name

Research Site

City

Savannah

State/Province

Georgia

ZIP/Postal Code

31405

Country

United States

Facility Name

Research Site

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60612

Country

United States

Facility Name

Research Site

City

Joliet

State/Province

Illinois

ZIP/Postal Code

60435

Country

United States

Facility Name

Research Site

City

Maywood

State/Province

Illinois

ZIP/Postal Code

60153

Country

United States

Facility Name

Research Site

City

Niles

State/Province

Illinois

ZIP/Postal Code

60714

Country

United States

Facility Name

Research Site

City

Skokie

State/Province

Illinois

ZIP/Postal Code

60076

Country

United States

Facility Name

Research Site

City

Skokie

State/Province

Illinois

ZIP/Postal Code

60077

Country

United States

Facility Name

Research Site

City

Anderson

State/Province

Indiana

ZIP/Postal Code

46016

Country

United States

Facility Name

Research Site

City

Fort Wayne

State/Province

Indiana

ZIP/Postal Code

46845

Country

United States

Facility Name

Research Site

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202

Country

United States

Facility Name

Research Site

City

Ames

State/Province

Iowa

ZIP/Postal Code

50010

Country

United States

Facility Name

Research Site

City

Iowa City

State/Province

Iowa

ZIP/Postal Code

52242

Country

United States

Facility Name

Research Site

City

Paducah

State/Province

Kentucky

ZIP/Postal Code

42003

Country

United States

Facility Name

Research Site

City

New Orleans

State/Province

Louisiana

ZIP/Postal Code

70121

Country

United States

Facility Name

Research Site

City

Scarborough

State/Province

Maine

ZIP/Postal Code

04074

Country

United States

Facility Name

Research Site

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21204

Country

United States

Facility Name

Research Site

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21229

Country

United States

Facility Name

Research Site

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21237

Country

United States

Facility Name

Research Site

City

Bethesda

State/Province

Maryland

ZIP/Postal Code

20817

Country

United States

Facility Name

Research Site

City

Westminster

State/Province

Maryland

ZIP/Postal Code

21157

Country

United States

Facility Name

Research Site

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

Facility Name

Research Site

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

Facility Name

Research Site

City

Danvers

State/Province

Massachusetts

ZIP/Postal Code

01923

Country

United States

Facility Name

Research Site

City

Fairhaven

State/Province

Massachusetts

ZIP/Postal Code

02719

Country

United States

Facility Name

Research Site

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48201

Country

United States

Facility Name

Research Site

City

Lansing

State/Province

Michigan

ZIP/Postal Code

48910

Country

United States

Facility Name

Research Site

City

Jackson

State/Province

Mississippi

ZIP/Postal Code

39216

Country

United States

Facility Name

Research Site

City

Springfield

State/Province

Missouri

ZIP/Postal Code

65806

Country

United States

Facility Name

Research Site

City

Billings

State/Province

Montana

ZIP/Postal Code

59101

Country

United States

Facility Name

Research Site

City

Lincoln

State/Province

Nebraska

ZIP/Postal Code

68506

Country

United States

Facility Name

Research Site

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68198

Country

United States

Facility Name

Research Site

City

North Las Vegas

State/Province

Nevada

ZIP/Postal Code

89086

Country

United States

Facility Name

Research Site

City

Hackensack

State/Province

New Jersey

ZIP/Postal Code

07601

Country

United States

Facility Name

Research Site

City

Lake Success

State/Province

New York

ZIP/Postal Code

11042

Country

United States

Facility Name

Research Site

City

New York

State/Province

New York

ZIP/Postal Code

10021

Country

United States

Facility Name

Research Site

City

Rochester

State/Province

New York

ZIP/Postal Code

14621

Country

United States

Facility Name

Research Site

City

Fayetteville

State/Province

North Carolina

ZIP/Postal Code

28304

Country

United States

Facility Name

Research Site

City

Goldsboro

State/Province

North Carolina

ZIP/Postal Code

27534

Country

United States

Facility Name

Research Site

City

High Point

State/Province

North Carolina

ZIP/Postal Code

27262

Country

United States

Facility Name

Research Site

City

Bismarck

State/Province

North Dakota

ZIP/Postal Code

58501

Country

United States

Facility Name

Research Site

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73120-8345

Country

United States

Facility Name

Research Site

City

Hershey

State/Province

Pennsylvania

ZIP/Postal Code

17033

Country

United States

Facility Name

Research Site

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19106

Country

United States

Facility Name

Research Site

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19140

Country

United States

Facility Name

Research Site

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19141

Country

United States

Facility Name

Research Site

City

West Reading

State/Province

Pennsylvania

ZIP/Postal Code

19611

Country

United States

Facility Name

Research Site

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29406

Country

United States

Facility Name

Research Site

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29414

Country

United States

Facility Name

Research Site

City

Greenville

State/Province

South Carolina

ZIP/Postal Code

29615

Country

United States

Facility Name

Research Site

City

Aberdeen

State/Province

South Dakota

ZIP/Postal Code

57401

Country

United States

Facility Name

Research Site

City

Rapid City

State/Province

South Dakota

ZIP/Postal Code

57701

Country

United States

Facility Name

Research Site

City

Sioux Falls

State/Province

South Dakota

ZIP/Postal Code

57105

Country

United States

Facility Name

Research Site

City

Watertown

State/Province

South Dakota

ZIP/Postal Code

57201

Country

United States

Facility Name

Research Site

City

Memphis

State/Province

Tennessee

ZIP/Postal Code

38120

Country

United States

Facility Name

Research Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Research Site

City

Lubbock

State/Province

Texas

ZIP/Postal Code

79415

Country

United States

Facility Name

Research Site

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84106

Country

United States

Facility Name

Research Site

City

Christiansburg

State/Province

Virginia

ZIP/Postal Code

24073

Country

United States

Facility Name

Research Site

City

Spokane

State/Province

Washington

ZIP/Postal Code

99208

Country

United States

Facility Name

Research Site

City

Tacoma

State/Province

Washington

ZIP/Postal Code

98405

Country

United States

Facility Name

Research Site

City

Morgantown

State/Province

West Virginia

ZIP/Postal Code

26506

Country

United States

Facility Name

Research Site

City

Minocqua

State/Province

Wisconsin

ZIP/Postal Code

54548

Country

United States

Facility Name

Research Site

City

Wauwatosa

State/Province

Wisconsin

ZIP/Postal Code

53226

Country

United States

Facility Name

Research Site

City

Liverpool

State/Province

New South Wales

ZIP/Postal Code

2170

Country

Australia

Facility Name

Research Site

City

Tweed Heads

State/Province

New South Wales

ZIP/Postal Code

2485

Country

Australia

Facility Name

Research Site

City

Douglas

State/Province

Queensland

ZIP/Postal Code

4814

Country

Australia

Facility Name

Research Site

City

South Brisbane

State/Province

Queensland

ZIP/Postal Code

4101

Country

Australia

Facility Name

Research Site

City

Hobart

State/Province

Tasmania

ZIP/Postal Code

7000

Country

Australia

Facility Name

Research Site

City

Clayton

State/Province

Victoria

ZIP/Postal Code

3168

Country

Australia

Facility Name

Research Site

City

Epping

State/Province

Victoria

ZIP/Postal Code

3076

Country

Australia

Facility Name

Research Site

City

Malvern

State/Province

Victoria

ZIP/Postal Code

3144

Country

Australia

Facility Name

Research Site

City

Parkville

State/Province

Victoria

ZIP/Postal Code

3050

Country

Australia

Facility Name

Research Site

City

Prahran

State/Province

Victoria

ZIP/Postal Code

3181

Country

Australia

Facility Name

Research Site

City

Graz

ZIP/Postal Code

8036

Country

Austria

Facility Name

Research Site

City

Innsbruck

ZIP/Postal Code

6020

Country

Austria

Facility Name

Research Site

City

Krems an der Donau

ZIP/Postal Code

3500

Country

Austria

Facility Name

Research Site

City

Salzburg

ZIP/Postal Code

5020

Country

Austria

Facility Name

Research Site

City

Wels

ZIP/Postal Code

4600

Country

Austria

Facility Name

Research Site

City

Wien

ZIP/Postal Code

1090

Country

Austria

Facility Name

Research Site

City

Wien

ZIP/Postal Code

1140

Country

Austria

Facility Name

Research Site

City

Pleven

ZIP/Postal Code

5800

Country

Bulgaria

Facility Name

Research Site

City

Plovdiv

ZIP/Postal Code

4002

Country

Bulgaria

Facility Name

Research Site

City

Sofia

ZIP/Postal Code

1407

Country

Bulgaria

Facility Name

Research Site

City

Sofia

ZIP/Postal Code

1431

Country

Bulgaria

Facility Name

Research Site

City

Sofia

ZIP/Postal Code

1606

Country

Bulgaria

Facility Name

Research Site

City

Sofia

ZIP/Postal Code

1756

Country

Bulgaria

Facility Name

Research Site

City

Varna

ZIP/Postal Code

9010

Country

Bulgaria

Facility Name

Research Site

City

Burnaby

State/Province

British Columbia

ZIP/Postal Code

V5G 2X6

Country

Canada

Facility Name

Research Site

City

Winnipeg

State/Province

Manitoba

ZIP/Postal Code

R3E 0V9

Country

Canada

Facility Name

Research Site

City

Moncton

State/Province

New Brunswick

ZIP/Postal Code

E1C 6Z8

Country

Canada

Facility Name

Research Site

City

St. Johns

State/Province

Newfoundland and Labrador

ZIP/Postal Code

A1B 3V6

Country

Canada

Facility Name

Research Site

City

Barrie

State/Province

Ontario

ZIP/Postal Code

L4M 6M2

Country

Canada

Facility Name

Research Site

City

Newmarket

State/Province

Ontario

ZIP/Postal Code

L3Y 2P9

Country

Canada

Facility Name

Research Site

City

Sault Ste. Marie

State/Province

Ontario

ZIP/Postal Code

P6B 0A8

Country

Canada

Facility Name

Research Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M2K 1E1

Country

Canada

Facility Name

Research Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M3M 0B2

Country

Canada

Facility Name

Research Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5B 1W8

Country

Canada

Facility Name

Research Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M6R 1B5

Country

Canada

Facility Name

Research Site

City

Windsor

State/Province

Ontario

ZIP/Postal Code

N8W 2X3

Country

Canada

Facility Name

Research Site

City

Laval

State/Province

Quebec

ZIP/Postal Code

H7M 3L9

Country

Canada

Facility Name

Research Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H4J 1C5

Country

Canada

Facility Name

Research Site

City

Montréal

State/Province

Quebec

ZIP/Postal Code

H1T 2M4

Country

Canada

Facility Name

Research Site

City

Trois-Rivières

State/Province

Quebec

ZIP/Postal Code

G8Z 3R9

Country

Canada

Facility Name

Research Site

City

Quebec

ZIP/Postal Code

G1R 2J6

Country

Canada

Facility Name

Research Site

City

Brno

ZIP/Postal Code

625 00

Country

Czechia

Facility Name

Research Site

City

Ostrava-Poruba

ZIP/Postal Code

708 52

Country

Czechia

Facility Name

Research Site

City

Plzen

ZIP/Postal Code

304 60

Country

Czechia

Facility Name

Research Site

City

Praha 10

ZIP/Postal Code

100 34

Country

Czechia

Facility Name

Research Site

City

Praha 2

ZIP/Postal Code

128 08

Country

Czechia

Facility Name

Research Site

City

Amiens Cedex 1

ZIP/Postal Code

80054

Country

France

Facility Name

Research Site

City

Avignon Cedex 9

ZIP/Postal Code

84902

Country

France

Facility Name

Research Site

City

Creteil

ZIP/Postal Code

94010

Country

France

Facility Name

Research Site

City

Le Kremlin Bicetre

ZIP/Postal Code

94270

Country

France

Facility Name

Research Site

City

Le Mans Cedex 9

ZIP/Postal Code

72037

Country

France

Facility Name

Research Site

City

Le Mans

ZIP/Postal Code

72000

Country

France

Facility Name

Research Site

City

Lille

ZIP/Postal Code

59037

Country

France

Facility Name

Research Site

City

Lyon Cédex 3

ZIP/Postal Code

69437

Country

France

Facility Name

Research Site

City

Marseille cedex 5

ZIP/Postal Code

13385

Country

France

Facility Name

Research Site

City

Marseille Cedex 9

ZIP/Postal Code

13273

Country

France

Facility Name

Research Site

City

Nantes Cedex 1

ZIP/Postal Code

44035

Country

France

Facility Name

Research Site

City

Nice Cedex 3

ZIP/Postal Code

06202

Country

France

Facility Name

Research Site

City

Paris Cedex 12

ZIP/Postal Code

75571

Country

France

Facility Name

Research Site

City

Paris Cedex 14

ZIP/Postal Code

75679

Country

France

Facility Name

Research Site

City

Paris

ZIP/Postal Code

75010

Country

France

Facility Name

Research Site

City

Paris

ZIP/Postal Code

75013

Country

France

Facility Name

Research Site

City

Paris

ZIP/Postal Code

75015

Country

France

Facility Name

Research Site

City

Pessac Cedex

ZIP/Postal Code

33604

Country

France

Facility Name

Research Site

City

Pierre-Benite cedex

ZIP/Postal Code

69495

Country

France

Facility Name

Research Site

City

Pontoise Cedex

ZIP/Postal Code

95301

Country

France

Facility Name

Research Site

City

Reims Cedex

ZIP/Postal Code

51056

Country

France

Facility Name

Research Site

City

Rouen cedex

ZIP/Postal Code

76038

Country

France

Facility Name

Research Site

City

Saint Quentin

ZIP/Postal Code

02321

Country

France

Facility Name

Research Site

City

Strasbourg

ZIP/Postal Code

67000

Country

France

Facility Name

Research Site

City

Villefranche Sur Saone Cedex

ZIP/Postal Code

69400

Country

France

Facility Name

Research Site

City

Bonn

ZIP/Postal Code

53127

Country

Germany

Facility Name

Research Site

City

Chemnitz

ZIP/Postal Code

09113

Country

Germany

Facility Name

Research Site

City

Essen

ZIP/Postal Code

45239

Country

Germany

Facility Name

Research Site

City

Hamburg

ZIP/Postal Code

20246

Country

Germany

Facility Name

Research Site

City

Kassel

ZIP/Postal Code

34125

Country

Germany

Facility Name

Research Site

City

Köln

ZIP/Postal Code

50924

Country

Germany

Facility Name

Research Site

City

Leipzig

ZIP/Postal Code

04103

Country

Germany

Facility Name

Research Site

City

Münster

ZIP/Postal Code

48149

Country

Germany

Facility Name

Research Site

City

Regensburg

ZIP/Postal Code

93049

Country

Germany

Facility Name

Research Site

City

Athens

ZIP/Postal Code

11525

Country

Greece

Facility Name

Research Site

City

Athens

ZIP/Postal Code

11527

Country

Greece

Facility Name

Research Site

City

Athens

ZIP/Postal Code

11528

Country

Greece

Facility Name

Research Site

City

Heraklion

ZIP/Postal Code

71110

Country

Greece

Facility Name

Research Site

City

Patra

ZIP/Postal Code

26500

Country

Greece

Facility Name

Research Site

City

Piraeus

ZIP/Postal Code

18537

Country

Greece

Facility Name

Research Site

City

Thessaloniki

ZIP/Postal Code

57010

Country

Greece

Facility Name

Research Site

City

Hong Kong

Country

Hong Kong

Facility Name

Research Site

City

New Territories

Country

Hong Kong

Facility Name

Research Site

City

Budapest

ZIP/Postal Code

1083

Country

Hungary

Facility Name

Research Site

City

Budapest

ZIP/Postal Code

1097

Country

Hungary

Facility Name

Research Site

City

Debrecen

ZIP/Postal Code

4032

Country

Hungary

Facility Name

Research Site

City

Gyor

ZIP/Postal Code

9024

Country

Hungary

Facility Name

Research Site

City

Gyula

ZIP/Postal Code

5700

Country

Hungary

Facility Name

Research Site

City

Kaposvar

ZIP/Postal Code

7400

Country

Hungary

Facility Name

Research Site

City

Szeged

ZIP/Postal Code

6725

Country

Hungary

Facility Name

Research Site

City

Dublin

ZIP/Postal Code

Country

Ireland

Facility Name

Research Site

City

Dublin

ZIP/Postal Code

Country

Ireland

Facility Name

Research Site

City

Dublin

ZIP/Postal Code

Country

Ireland

Facility Name

Research Site

City

Limerick

Country

Ireland

Facility Name

Research Site

City

Tullamore

Country

Ireland

Facility Name

Research Site

City

Ancona

ZIP/Postal Code

60126

Country

Italy

Facility Name

Research Site

City

Bari

ZIP/Postal Code

70124

Country

Italy

Facility Name

Research Site

City

Brescia

ZIP/Postal Code

25125

Country

Italy

Facility Name

Research Site

City

Busto Arsizio

ZIP/Postal Code

21052

Country

Italy

Facility Name

Research Site

City

Catania

ZIP/Postal Code

95124

Country

Italy

Facility Name

Research Site

City

Firenze

ZIP/Postal Code

50134

Country

Italy

Facility Name

Research Site

City

Genova

ZIP/Postal Code

16132

Country

Italy

Facility Name

Research Site

City

Messina

ZIP/Postal Code

98125

Country

Italy

Facility Name

Research Site

City

Milano

ZIP/Postal Code

20153

Country

Italy

Facility Name

Research Site

City

Napoli

ZIP/Postal Code

80131

Country

Italy

Facility Name

Research Site

City

Napoli

ZIP/Postal Code

80136

Country

Italy

Facility Name

Research Site

City

Novara

ZIP/Postal Code

28100

Country

Italy

Facility Name

Research Site

City

Palermo

ZIP/Postal Code

90146

Country

Italy

Facility Name

Research Site

City

Pescara

ZIP/Postal Code

65124

Country

Italy

Facility Name

Research Site

City

Pisa

ZIP/Postal Code

56127

Country

Italy

Facility Name

Research Site

City

Roma

ZIP/Postal Code

00144

Country

Italy

Facility Name

Research Site

City

Roma

ZIP/Postal Code

00161

Country

Italy

Facility Name

Research Site

City

Rozzano MI

ZIP/Postal Code

20089

Country

Italy

Facility Name

Research Site

City

Torino

ZIP/Postal Code

10126

Country

Italy

Facility Name

Research Site

City

Udine

ZIP/Postal Code

33100

Country

Italy

Facility Name

Research Site

City

Vimercate MB

ZIP/Postal Code

20871

Country

Italy

Facility Name

Research Site

City

Nagoya-shi

State/Province

Aichi

ZIP/Postal Code

457-8510

Country

Japan

Facility Name

Research Site

City

Akita-shi

State/Province

Akita

ZIP/Postal Code

010-8543

Country

Japan

Facility Name

Research Site

City

Kamogawa-shi

State/Province

Chiba

ZIP/Postal Code

296-8602

Country

Japan

Facility Name

Research Site

City

Fukuoka-shi

State/Province

Fukuoka

ZIP/Postal Code

814-0180

Country

Japan

Facility Name

Research Site

City

Gifu-shi

State/Province

Gifu

ZIP/Postal Code

501-1194

Country

Japan

Facility Name

Research Site

City

Ogaki-shi

State/Province

Gifu

ZIP/Postal Code

503-8502

Country

Japan

Facility Name

Research Site

City

Maebashi-shi

State/Province

Gunma

ZIP/Postal Code

371-8511

Country

Japan

Facility Name

Research Site

City

Shibukawa-shi

State/Province

Gunma

ZIP/Postal Code

377-8511

Country

Japan

Facility Name

Research Site

City

Fukuyama-shi

State/Province

Hiroshima

ZIP/Postal Code

720-0001

Country

Japan

Facility Name

Research Site

City

Kobe-shi

State/Province

Hyogo

ZIP/Postal Code

650-0047

Country

Japan

Facility Name

Research Site

City

Kumamoto-shi

State/Province

Kumamoto

ZIP/Postal Code

860-0008

Country

Japan

Facility Name

Research Site

City

Kyoto-shi

State/Province

Kyoto

ZIP/Postal Code

603-8151

Country

Japan

Facility Name

Research Site

City

Okayama-shi

State/Province

Okayama

ZIP/Postal Code

701-1192

Country

Japan

Facility Name

Research Site

City

Kawagoe-shi

State/Province

Saitama

ZIP/Postal Code

350-8550

Country

Japan

Facility Name

Research Site

City

Tokushima-shi

State/Province

Tokushima

ZIP/Postal Code

770-8503

Country

Japan

Facility Name

Research Site

City

Shibuya-ku

State/Province

Tokyo

ZIP/Postal Code

150-8935

Country

Japan

Facility Name

Research Site

City

Shinjuku-ku

State/Province

Tokyo

ZIP/Postal Code

162-8655

Country

Japan

Facility Name

Research Site

City

Toyama-shi

State/Province

Toyama

ZIP/Postal Code

930-8550

Country

Japan

Facility Name

Research Site

City

Anyang

ZIP/Postal Code

431-070

Country

Korea, Republic of

Facility Name

Research Site

City

Busan

ZIP/Postal Code

602-739

Country

Korea, Republic of

Facility Name

Research Site

City

Daegu

ZIP/Postal Code

700-721

Country

Korea, Republic of

Facility Name

Research Site

City

Daejeon

ZIP/Postal Code

301-721

Country

Korea, Republic of

Facility Name

Research Site

City

Gwangju

ZIP/Postal Code

519-763

Country

Korea, Republic of

Facility Name

Research Site

City

Incheon

ZIP/Postal Code

405-760

Country

Korea, Republic of

Facility Name

Research Site

City

Seoul

ZIP/Postal Code

110-744

Country

Korea, Republic of

Facility Name

Research Site

City

Seoul

ZIP/Postal Code

120-752

Country

Korea, Republic of

Facility Name

Research Site

City

Seoul

ZIP/Postal Code

135-710

Country

Korea, Republic of

Facility Name

Research Site

City

Seoul

ZIP/Postal Code

137-701

Country

Korea, Republic of

Facility Name

Research Site

City

Seoul

ZIP/Postal Code

158-710

Country

Korea, Republic of

Facility Name

Research Site

City

Kaunas

ZIP/Postal Code

50009

Country

Lithuania

Facility Name

Research Site

City

Vilnius

ZIP/Postal Code

LT-08661

Country

Lithuania

Facility Name

Research Site

City

Ipoh

State/Province

Perak

ZIP/Postal Code

30990

Country

Malaysia

Facility Name

Research Site

City

Georgetown

State/Province

Pinang

ZIP/Postal Code

10990

Country

Malaysia

Facility Name

Research Site

City

Kuching

State/Province

Sarawak

ZIP/Postal Code

93586

Country

Malaysia

Facility Name

Research Site

City

Ampang

ZIP/Postal Code

68000

Country

Malaysia

Facility Name

Research Site

City

Christchurch

ZIP/Postal Code

8011

Country

New Zealand

Facility Name

Research Site

City

Grafton, Auckland

ZIP/Postal Code

1023

Country

New Zealand

Facility Name

Research Site

City

Legnica

ZIP/Postal Code

59-220

Country

Poland

Facility Name

Research Site

City

Lublin

ZIP/Postal Code

20-081

Country

Poland

Facility Name

Research Site

City

Slupsk

ZIP/Postal Code

76-200

Country

Poland

Facility Name

Research Site

City

Torun

ZIP/Postal Code

87-100

Country

Poland

Facility Name

Research Site

City

Warszawa

ZIP/Postal Code

02-097

Country

Poland

Facility Name

Research Site

City

Warszawa

ZIP/Postal Code

02-776

Country

Poland

Facility Name

Research Site

City

Wroclaw

ZIP/Postal Code

53-439

Country

Poland

Facility Name

Research Site

City

Braga

ZIP/Postal Code

4710-243

Country

Portugal

Facility Name

Research Site

City

Coimbra

ZIP/Postal Code

3000-075

Country

Portugal

Facility Name

Research Site

City

Lisboa

ZIP/Postal Code

1169-050

Country

Portugal

Facility Name

Research Site

City

Matosinhos

ZIP/Postal Code

4464-513

Country

Portugal

Facility Name

Research Site

City

Porto

ZIP/Postal Code

4200-072

Country

Portugal

Facility Name

Research Site

City

Dzerzhinsk

ZIP/Postal Code

606019

Country

Russian Federation

Facility Name

Research Site

City

Ekaterinburg

ZIP/Postal Code

620102

Country

Russian Federation

Facility Name

Research Site

City

Moscow

ZIP/Postal Code

115478

Country

Russian Federation

Facility Name

Research Site

City

Nizhny Novgorod

ZIP/Postal Code

603126

Country

Russian Federation

Facility Name

Research Site

City

Novosibirsk

ZIP/Postal Code

630051

Country

Russian Federation

Facility Name

Research Site

City

Penza

ZIP/Postal Code

440071

Country

Russian Federation

Facility Name

Research Site

City

Petrozavodsk

ZIP/Postal Code

185019

Country

Russian Federation

Facility Name

Research Site

City

Saint Petersburg

ZIP/Postal Code

198205

Country

Russian Federation

Facility Name

Research Site

City

Saint-Petersburg

ZIP/Postal Code

193312

Country

Russian Federation

Facility Name

Research Site

City

Saint-Petersburg

ZIP/Postal Code

197110

Country

Russian Federation

Facility Name

Research Site

City

Samara

ZIP/Postal Code

443099

Country

Russian Federation

Facility Name

Research Site

City

Saratov

ZIP/Postal Code

410012

Country

Russian Federation

Facility Name

Research Site

City

St. Petersburg

ZIP/Postal Code

197022

Country

Russian Federation

Facility Name

Research Site

City

Volgograd

ZIP/Postal Code

400138

Country

Russian Federation

Facility Name

Research Site

City

Singapore

ZIP/Postal Code

119228

Country

Singapore

Facility Name

Research Site

City

Singapore

ZIP/Postal Code

169856

Country

Singapore

Facility Name

Research Site

City

Singapore

ZIP/Postal Code

308433

Country

Singapore

Facility Name

Research Site

City

Bratislava

ZIP/Postal Code

851 07

Country

Slovakia

Facility Name

Research Site

City

Nitra

ZIP/Postal Code

950 01

Country

Slovakia

Facility Name

Research Site

City

Nove Zamky

ZIP/Postal Code

940 34

Country

Slovakia

Facility Name

Research Site

City

Sevilla

State/Province

Andalucía

ZIP/Postal Code

41013

Country

Spain

Facility Name

Research Site

City

Palma de Mallorca

State/Province

Baleares

ZIP/Postal Code

07198

Country

Spain

Facility Name

Research Site

City

Salamanca

State/Province

Castilla León

ZIP/Postal Code

37007

Country

Spain

Facility Name

Research Site

City

Badalona

State/Province

Cataluña

ZIP/Postal Code

08916

Country

Spain

Facility Name

Research Site

City

Barcelona

State/Province

Cataluña

ZIP/Postal Code

08036

Country

Spain

Facility Name

Research Site

City

Valencia

State/Province

Comunidad Valenciana

ZIP/Postal Code

46017

Country

Spain

Facility Name

Research Site

City

Valencia

State/Province

Comunidad Valenciana

ZIP/Postal Code

46026

Country

Spain

Facility Name

Research Site

City

Ourense

State/Province

Galicia

ZIP/Postal Code

32005

Country

Spain

Facility Name

Research Site

City

San Sebastian

State/Province

País Vasco

ZIP/Postal Code

20014

Country

Spain

Facility Name

Research Site

City

Madrid

ZIP/Postal Code

28006

Country

Spain

Facility Name

Research Site

City

Madrid

ZIP/Postal Code

28034

Country

Spain

Facility Name

Research Site

City

Chur

ZIP/Postal Code

7000

Country

Switzerland

Facility Name

Research Site

City

Zurich

ZIP/Postal Code

8032

Country

Switzerland

Facility Name

Research Site

City

Zurich

ZIP/Postal Code

8038

Country

Switzerland

Facility Name

Research Site

City

Changhua

ZIP/Postal Code

50006

Country

Taiwan

Facility Name

Research Site

City

Kaohsiung

ZIP/Postal Code

83301

Country

Taiwan

Facility Name

Research Site

City

Taichung

ZIP/Postal Code

40447

Country

Taiwan

Facility Name

Research Site

City

Taichung

ZIP/Postal Code

407

Country

Taiwan

Facility Name

Research Site

City

Tainan

ZIP/Postal Code

70403

Country

Taiwan

Facility Name

Research Site

City

Taipei

ZIP/Postal Code

10002

Country

Taiwan

Facility Name

Research Site

City

Taoyuan

ZIP/Postal Code

33305

Country

Taiwan

Facility Name

Research Site

City

Adana

ZIP/Postal Code

01330

Country

Turkey

Facility Name

Research Site

City

Ankara

ZIP/Postal Code

06100

Country

Turkey

Facility Name

Research Site

City

Ankara

ZIP/Postal Code

06500

Country

Turkey

Facility Name

Research Site

City

Istanbul

ZIP/Postal Code

34452

Country

Turkey

Facility Name

Research Site

City

Izmir

ZIP/Postal Code

35340

Country

Turkey

Facility Name

Research Site

City

Cherkasy

ZIP/Postal Code

18009

Country

Ukraine

Facility Name

Research Site

City

Dnipropetrovsk

ZIP/Postal Code

49102

Country

Ukraine

Facility Name

Research Site

City

Ivano-Frankivsk

ZIP/Postal Code

76008

Country

Ukraine

Facility Name

Research Site

City

Khmelnitskiy

ZIP/Postal Code

29000

Country

Ukraine

Facility Name

Research Site

City

Kyiv

ZIP/Postal Code

04107

Country

Ukraine

Facility Name

Research Site

City

Lviv

ZIP/Postal Code

79031

Country

Ukraine

Facility Name

Research Site

City

Poltava

ZIP/Postal Code

36024

Country

Ukraine

Facility Name

Research Site

City

Harrow

ZIP/Postal Code

HA1 3UJ

Country

United Kingdom

Facility Name

Research Site

City

Inverness

ZIP/Postal Code

IV2 3UJ

Country

United Kingdom

Facility Name

Research Site

City

Leeds

ZIP/Postal Code

LS9 7TF

Country

United Kingdom

Facility Name

Research Site

City

London

ZIP/Postal Code

NW3 2QG

Country

United Kingdom

Facility Name

Research Site

City

London

ZIP/Postal Code

SW17 0RE

Country

United Kingdom

Facility Name

Research Site

City

Oxford

ZIP/Postal Code

OX3 7LJ

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing URL

https://www.amgen.com/datasharing

Citations:

PubMed Identifier

29480139

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.

Results Reference

background

PubMed Identifier

29429912

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.

Results Reference

background

PubMed Identifier

32524500

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.

Results Reference

background

PubMed Identifier

33560384

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.

Results Reference

background

Links:

URL

http://www.amgentrials.com

Description

AmgenTrials clinical trials website

Learn more about this trial

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

We'll reach out to this number within 24 hrs

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

Cancer, Hematologic Malignancies, Multiple Myeloma

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial