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A Study of VELCADE (Bortezomib) Melphalan-Prednisone (VMP) Compared to Daratumumab in Combination With VMP (D-VMP), in Participants With Previously Untreated Multiple Myeloma Who Are Ineligible for High-Dose Therapy (Asia Pacific Region)

Primary Purpose

Multiple Myeloma

Status

Active

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Velcade

Melphalan

Prednisone

Daratumumab

About this trial

This is an interventional treatment trial for Multiple Myeloma

Eligibility Criteria

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

Inclusion Criteria:

Documented multiple myeloma satisfying the calcium elevation, renal insufficiency, anemia, and bone abnormalities (CRAB) diagnostic criteria, monoclonal plasma cells in the bone marrow greater than or equal to (>=) 10 percent (%) or presence of a biopsy proven plasmacytomas, and measurable secretory disease, as assessed by the central laboratory, and defined in protocol
Newly diagnosed and not considered candidate for high-dose chemotherapy with stem cell transplantation (SCT) due to: being age >= 65 years, or in participants less than (<) 65 years: presence of important comorbid conditions likely to have a negative impact on tolerability of high dose chemotherapy with stem cell transplantation
Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2
Meet the clinical laboratory criteria as specified in the protocol
A woman of childbearing potential must have a negative serum or urine pregnancy tests at screening within 14 days prior to randomization

Exclusion Criteria:

Primary amyloidosis, monoclonal gammopathy of undetermined significance, or smoldering multiple myeloma
Waldenstrom's disease, or other conditions in which Immunoglobulin M (IgM) M-protein is present in the absence of a clonal plasma cell infiltration with lytic bone lesions
Prior or current systemic therapy or SCT for multiple myeloma, with the exception of an emergency use of a short course (equivalent of dexamethasone 40 milligram per day (mg/day) for 4 days) of corticosteroids before treatment
Peripheral neuropathy or neuropathic pain Grade 2 or higher, as defined by the national cancer institute common terminology criteria for adverse events (NCI-CTCAE), Version 4.03
History of malignancy (other than multiple myeloma) within 3 years before the date of randomization (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy that in the opinion of the investigator, with concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence within 3 years)
Radiation therapy within 14 days of randomization
Seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen [HBsAg]). Participants with resolved infection (that is, participants who are HBsAg negative but positive for antibodies to hepatitis B core antigen [Anti-HBc] and/or antibodies to hepatitis B surface antigen [Anti-HBs]) must be screened using real-time polymerase chain reaction (PCR) measurement of hepatitis B virus (HBV) deoxyribonucleic acid (DNA) levels. Those who are PCR positive will be excluded. EXCEPTION: Participants with serologic findings suggestive of HBV vaccination (Anti-HBs positivity as the only serologic marker) AND a known history of prior HBV vaccination, do not need to be tested for HBV DNA by PCR

Sites / Locations

Beijing Chaoyang Hospital
Peking Union Medical College Hospital
Peking University First Hospital
Beijing Chaoyang Hospital
Peking University Third Hospital
The First Hospital of Jilin University
The Third Xiangya Hospital, Central South University
West China Hospital, Si Chuan University
Second Affiliated Hospital of Army Medical University
Fujian Meidical University Union Hospital
Guangdong Provincial People's Hospital
The First Affiliated Hospital, Sun Yat-sen University
Nanfang Hospital
First affiliated Hospital of Zhejiang University
First Affiliated Hospital, Medical School of Zhejiang University
Harbin medical university cancer hospital
Nanjing Drum Tower Hospital
Zhongda Hospital,Southeast University
Jiangsu Province Hospital
Shanghai Changzheng Hospital
Ruijin Hospital, Shanghai Jiao Tong University
Shanghai Zhongshan Hospital
Renji Hospital, Shanghai Jiaotong University School of Medicine
First Affiliated Hospital, SooChow University
Tianjin cancer hospital
Institute of Hematology & Blood Diseases Hospital
The First Affiliated Hospital of Wenzhou Medical University
Tongji Hospital, Tongji Medical College of HUST
Tangdu Hospital
Henan Cancer Hospital
Queen Mary Hospital, University of Hong Kong
Inje University Busan Paik Hospital
Seoul National University Bundang Hospital
Gachon University Gil Medical Center
Chonnam National University Hwasun Hospital
Samsung Medical Center
The Catholic University of Korea Seoul St. Mary's Hospital
Ulsan University Hospital
Hospital Ampang
Hospital Pulau Pinang
Hospital Queen Elizabeth
National Taiwan University Hospital
Taipei Veterans General Hospital
Chang Gung Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Treatment A: VMP Alone

Treatment B: D-VMP

Arm Description

Participants will receive Velcade (bortezomib) 1.3 milligram per square meter (mg/m^2) as subcutaneous (SC) injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at Weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2 (if serum creatine is greater than [>]2 milligram per deciliter [mg/dL] at baseline, participants must be administrated 4.5 mg/m^2 of melphalan, instead of 9 mg/m^2) orally, once daily (on Days 1 to 4) and prednisone 60 mg/m^2, orally, once daily on Days 1 to 4 of each cycle up to Cycle 9.

Participants will receive Velcade 1.3 mg/m^2 as SC injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at Weeks 1, 2, 4 and 5 in Cycles 2 to 9, melphalan 9 mg/m^2 (if serum creatine is >2 mg/dL at baseline, participants must be administrated 4.5 mg/m^2 of melphalan, instead of 9 mg/m^2), orally, once daily (on Days 1-4) and prednisone 60 mg/m^2, orally, once daily, on Days 1 to 4 of each cycle up to Cycle 9. In addition participants will also receive daratumumab 16 milligram per kilogram (mg/kg) as intravenous (IV) infusion or daratumumab Subcutaneously (SC) at the discretion of the investigator, once weekly, for 6 weeks in Cycle 1 and then every 3 weeks, in Cycles 2 to 9 and thereafter, once every 4 weeks until documented progression, unacceptable toxicity, or the end of study. Participants will receive pre-infusion medications before each daratumumab infusion.

Outcomes

Primary Outcome Measures

Very Good Partial Response (VGPR) or Better Rate at 6 Month After Last Participant First Dose

The VGPR or better rate, defined as the proportion of participants achieving VGPR and complete response (CR) (including stringent complete response [sCR]) according to the international myeloma working group (IMWG) criteria during or after the study treatment. IMWG criteria for VGPR: Serum and urine M-component detectable by immunofixation but not on electrophoresis, or greater than equal to (>=) 90 percent (%) reduction in serum M-protein plus urine M-protein <100 milligram (mg)/24 hours, CR: Negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas and less than (<) 5% plasma cells (PCs) in bone marrow. sCR: CR plus normal free light chain (FLC) ratio, and absence of clonal PCs by immunohistochemistry (IHC), immunofluorescence or 2- to 4 color flow cytometry.

Very Good Partial Response (VGPR) or Better Rate at 3 Years After Last Participant First Dose

The VGPR or better rate, defined as the proportion of participants achieving VGPR and CR (including sCR) according to the IMWG criteria during or after the study treatment. IMWG criteria for VGPR: Serum and urine M-component detectable by immunofixation but not on electrophoresis, or >=90 % reduction in serum M-protein plus urine M-protein <100 mg/24 hours, CR: Negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas and <5% plasma cells (PCs) in bone marrow. sCR: CR plus normal free light chain (FLC) ratio, and absence of clonal PCs by immunohistochemistry (IHC), immunofluorescence or 2- to 4 color flow cytometry.

Secondary Outcome Measures

Progression-Free Survival (PFS)

The PFS is defined as time from date of randomization to either Progressive disease (PD), death, whichever occurs first according to IMWG criteria. IMWG criteria for PD: Increase of 25% from lowest response value in any one of following: Serum M-component (absolute increase must be >=0.5 gram per deciliter (g/dL), Urine M-component (absolute increase must be >=200 mg/24 hours), Participants without measurable serum and urine M-protein levels: the difference between involved and uninvolved FLC levels (absolute increase must be >10 milligrams per deciliter (mg/dL), participants without measurable serum and urine M-protein levels and without measurable disease by FLC levels, bone marrow PC% (absolute percentage must be >=10%), definite development of new bone lesions or soft tissue plasmacytomas or increase in size of bone lesions or tissue plasmacytomas and development of hypercalcemia (serum calcium >11.5 mg/dL) that can be attributed solely to PC proliferative disorder.

Time to Next Treatment

Time to next treatment is defined as the time from randomization to the start of the next-line treatment.

Overall Response Rate (ORR)

The ORR is defined as the proportion of participants who achieve partial response (PR) or better according to IMWG criteria, during or after study treatment. IMWG criteria: >=50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by >=90% or to <200 mg/24 hours, If the serum and urine M-protein are not measurable, a decrease of >=50% in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria, If serum and urine M-protein are not measurable, and serum free light assay is also not measurable, >=50% reduction in bone marrow plasma cells (PCs) is required in place of M-protein, provided baseline bone marrow plasma cell percentage was >=30%. In addition to the above criteria, if present at baseline, a >=50% reduction in the size of soft tissue plasmacytomas is also required.

Complete Response Rate

Complete response based on IMWG criteria is defined as: Negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas and <5% PCs in bone marrow.

Stringent Complete Response (sCR) Rate

Time to response, defined as the time between randomization and the first efficacy evaluation that the participant has met all criteria for PR or better. IMWG criteria for PR: >=50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by>=90% or to <200 mg/24 hours, If the serum and urine M-protein are not measurable, a decrease of >=50% in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria, If serum and urine M-protein are not measurable, and serum free light assay is also not measurable, >=50% reduction in bone marrow PCs is required in place of M-protein, provided baseline bone marrow plasma cell percentage was >=30%. In addition to the above criteria, if present at baseline, a >=50% reduction in the size of soft tissue plasmacytomas is also required.

Time to Response

Overall Survival (OS)

The OS is defined as the time from the date of randomization to the date of the participant's death.

Duration of Response

Duration of response is time from the date of initial documentation of response (PR or better) to the date of first documented evidence of PD, as defined by IMWG criteria. IMWG criteria for PD: Increase of 25% from lowest response value in any one of the following: Serum M-component (absolute increase must be >=0.5 g/dL, Urine M-component (absolute increase must be >=200 mg/24 hours), Participants without measurable serum and urine M-protein levels: the difference between involved and uninvolved FLC levels (absolute increase must be >10 milligram per deciliter (mg/dL), participants without measurable serum and urine M-protein levels and without measurable disease by FLC levels, bone marrow PC%(absolute percentage must be >=10%), definite development of new bone lesions or soft tissue plasmacytomas or increase in size of bone lesions or tissue plasmacytomas and development of hypercalcemia ( serum calcium >11.5 mg/dL) that can be attributed solely to PC proliferative disorder.

Time to VGPR or Better Response

Time to VGPR or better response defined as the time between randomization and the first efficacy evaluation that the participant has met all criteria for VGPR or better in responders. IMWG criteria for VGPR: Serum and urine M-component detectable by immunofixation but not on electrophoresis, or greater than equal to (>=) 90 percent (%) reduction in serum M-protein plus urine M-protein <100 milligram (mg)/24 hours, CR: Negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas and <5% plasma cells (PCs) in bone marrow. sCR: CR plus normal free light chain (FLC) ratio, and absence of clonal PCs by immunohistochemistry (IHC), immunofluorescence or 2- to 4 color flow cytometry.

Duration of VGPR or Better Response

Duration of VGPR or better response is calculated from the date of initial documentation of the first (VGPR or better) to the date of first documented evidence of progressive disease, as defined in the IMWG criteria. IMWG criteria for VGPR: Serum and urine M-component detectable by immunofixation but not on electrophoresis, or greater than equal to (>=) 90 percent (%) reduction in serum M-protein plus urine M-protein <100 milligram (mg)/24 hours, CR: Negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas and <5% plasma cells (PCs) in bone marrow. sCR: CR plus normal free light chain (FLC) ratio, and absence of clonal PCs by immunohistochemistry (IHC), immunofluorescence or 2- to 4 color flow cytometry.

EuroQoL 5-Dimension 5-Level Health Status (EQ-5D-5L) Questionnaire

The EQ-5D questionnaire is a brief, generic health-related quality of life assessment (HRQOL) that can also be used to incorporate participant preferences into health economic evaluations. The EQ-5D-5L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression and as overall health using a "thermometer" visual analog scale with response options ranging from 0 (worst imaginable health) to 100 (best imaginable health).

European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Health Status (QLQ-C30) Questionnaire

The EORTC QLQ-C30 includes 30 items resulting in 5 functional scales (physical, role, cognitive, emotional, and social), 1 global health status scale, 3 symptom scales (fatigue, pain, nausea/vomiting) and 6 single items (dyspnea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). The recall period is 1 week (the past week). Scores are transformed to a 0 to 100 scale. Higher score=better level of functioning or greater degree of symptoms.

Number of Participants With Antibodies to Daratumumab

Number of participants with antibodies to daratumumab will be analysed.

Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability

An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.

Clinical Efficacy of D-VMP in High Risk Molecular Subgroups

Clinical efficacy will be analyzed in high risk molecular subgroups between DVMP and VMP.

Full Information

NCT ID

NCT03217812

First Posted

July 13, 2017

Last Updated

October 10, 2023

Sponsor

Janssen Research & Development, LLC

1. Study Identification

Unique Protocol Identification Number

NCT03217812

Brief Title

A Study of VELCADE (Bortezomib) Melphalan-Prednisone (VMP) Compared to Daratumumab in Combination With VMP (D-VMP), in Participants With Previously Untreated Multiple Myeloma Who Are Ineligible for High-Dose Therapy (Asia Pacific Region)

Official Title

A Phase 3, Multicenter, Randomized, Controlled, Open-label Study of VELCADE (Bortezomib) Melphalan-Prednisone (VMP) Compared to Daratumumab in Combination With VMP (D-VMP), in Subjects With Previously Untreated Multiple Myeloma Who Are Ineligible for High-Dose Therapy (Asia Pacific Region)

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

November 23, 2017 (Actual)

Primary Completion Date

July 2, 2020 (Actual)

Study Completion Date

December 18, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Janssen Research & Development, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to determine if the addition of daratumumab to VELCADE-melphalan-prednisone (VMP) will improve very good partial response (VGPR) or better compared with VMP alone.

6. Conditions and Keywords

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

Multiple Myeloma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

220 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment A: VMP Alone

Arm Type

Active Comparator

Arm Description

Arm Title

Treatment B: D-VMP

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Velcade

Other Intervention Name(s)

Bortezomib

Intervention Description

Participants will receive velcade 1.3 mg/m^2, SC injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at Weeks 1, 2, 4 and 5 in Cycles 2 to 9 of Treatment Arm A and B.

Intervention Type

Drug

Intervention Name(s)

Melphalan

Intervention Description

Participants will receive melphalan 9 mg/m^2 (if serum creatine is >2 mg/dL at baseline, participants must be administrated 4.5 mg/m^2 of melphalan, instead of 9 mg/m^2), orally, once daily on Days 1 to 4 of each cycle up to Cycle 9 Treatment Arm A and B.

Intervention Type

Drug

Intervention Name(s)

Prednisone

Intervention Description

Participants will receive prednisone 60 mg/m^2, orally, once daily, on Days 1 to 4 of each cycle up to Cycle 9 Treatment Arm A and B.

Intervention Type

Drug

Intervention Name(s)

Daratumumab

Other Intervention Name(s)

JNJ-54767414

Intervention Description

Participants will receive daratumumab 16 mg/kg as IV infusion or daratumumab SC, once weekly, for 6 weeks in Cycle 1 and then once every 3 weeks, in Cycle 2 to 9 and thereafter, once every 4 weeks until documented progression, unacceptable toxicity, or the end of study in Treatment Arm B.

Primary Outcome Measure Information:

Title

Very Good Partial Response (VGPR) or Better Rate at 6 Month After Last Participant First Dose

Description

Time Frame

At 6 months after last participant first dose (approximately up to 2.5 years)

Title

Very Good Partial Response (VGPR) or Better Rate at 3 Years After Last Participant First Dose

Description

Time Frame

At 3 years after last participant first dose (approximately up to 5 years)

Secondary Outcome Measure Information:

Title

Progression-Free Survival (PFS)

Description

Time Frame

Up to 6 months after last participant first dose (approximately up to 2.5 years) and 3 years after last participant first dose (approximately up to 5 years)

Title

Time to Next Treatment

Description

Time to next treatment is defined as the time from randomization to the start of the next-line treatment.

Time Frame

Up to 6 months after last participant first dose (approximately up to 2.5 years) and 3 years after last participant first dose (approximately up to 5 years)

Title

Overall Response Rate (ORR)

Description

Time Frame

At 6 months after last participant first dose (approximately up to 2.5 years) and 3 years after last participant first dose (approximately up to 5 years)

Title

Complete Response Rate

Description

Complete response based on IMWG criteria is defined as: Negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas and <5% PCs in bone marrow.

Time Frame

At 6 months after last participant first dose (approximately up to 2.5 years) and 3 years after last participant first dose (approximately up to 5 years)

Title

Stringent Complete Response (sCR) Rate

Description

Time Frame

At 6 months after last participant first dose (approximately up to 2.5 years) and 3 years after last participant first dose (approximately up to 5 years)

Title

Time to Response

Description

Time Frame

Up to 6 months after last participant first dose (approximately up to 2.5 years) and 3 years after last participant first dose (approximately up to 5 years)

Title

Overall Survival (OS)

Description

The OS is defined as the time from the date of randomization to the date of the participant's death.

Time Frame

Up to 6 months after last participant first dose (approximately up to 2.5 years) and 3 years after last participant first dose (approximately up to 5 years)

Title

Duration of Response

Description

Time Frame

Up to 6 months after last participant first dose (approximately up to 2.5 years) and 3 years after last participant first dose (approximately up to 5 years)

Title

Time to VGPR or Better Response

Description

Time Frame

Up to 6 months after last participant first dose (approximately up to 2.5 years) and 3 years after last participant first dose (approximately up to 5 years)

Title

Duration of VGPR or Better Response

Description

Time Frame

Up to 6 months after last participant first dose (approximately up to 2.5 years) and 3 years after last participant first dose (approximately up to 5 years)

Title

EuroQoL 5-Dimension 5-Level Health Status (EQ-5D-5L) Questionnaire

Description

Time Frame

At 6 months after last participant first dose (approximately up to 2.5 years) and 3 years after last participant first dose (approximately up to 5 years)

Title

European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Health Status (QLQ-C30) Questionnaire

Description

Time Frame

At 6 months after last participant first dose (approximately up to 2.5 years) and 3 years after last participant first dose (approximately up to 5 years)

Title

Number of Participants With Antibodies to Daratumumab

Description

Number of participants with antibodies to daratumumab will be analysed.

Time Frame

Up to 6 months after last participant first dose (approximately up to 2.5 years) and 3 years after last participant first dose (approximately up to 5 years)

Title

Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability

Description

An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.

Time Frame

Up to 6 months after last participant first dose (approximately up to 2.5 years) and 3 years after last participant first dose (approximately up to 5 years)

Title

Clinical Efficacy of D-VMP in High Risk Molecular Subgroups

Description

Clinical efficacy will be analyzed in high risk molecular subgroups between DVMP and VMP.

Time Frame

Up to 6 months after last participant first dose (approximately up to 2.5 years) and 3 years after last participant first dose (approximately up to 5 years)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Documented multiple myeloma satisfying the calcium elevation, renal insufficiency, anemia, and bone abnormalities (CRAB) diagnostic criteria, monoclonal plasma cells in the bone marrow greater than or equal to (>=) 10 percent (%) or presence of a biopsy proven plasmacytomas, and measurable secretory disease, as assessed by the central laboratory, and defined in protocol Newly diagnosed and not considered candidate for high-dose chemotherapy with stem cell transplantation (SCT) due to: being age >= 65 years, or in participants less than (<) 65 years: presence of important comorbid conditions likely to have a negative impact on tolerability of high dose chemotherapy with stem cell transplantation Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2 Meet the clinical laboratory criteria as specified in the protocol A woman of childbearing potential must have a negative serum or urine pregnancy tests at screening within 14 days prior to randomization Exclusion Criteria: Primary amyloidosis, monoclonal gammopathy of undetermined significance, or smoldering multiple myeloma Waldenstrom's disease, or other conditions in which Immunoglobulin M (IgM) M-protein is present in the absence of a clonal plasma cell infiltration with lytic bone lesions Prior or current systemic therapy or SCT for multiple myeloma, with the exception of an emergency use of a short course (equivalent of dexamethasone 40 milligram per day (mg/day) for 4 days) of corticosteroids before treatment Peripheral neuropathy or neuropathic pain Grade 2 or higher, as defined by the national cancer institute common terminology criteria for adverse events (NCI-CTCAE), Version 4.03 History of malignancy (other than multiple myeloma) within 3 years before the date of randomization (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy that in the opinion of the investigator, with concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence within 3 years) Radiation therapy within 14 days of randomization Seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen [HBsAg]). Participants with resolved infection (that is, participants who are HBsAg negative but positive for antibodies to hepatitis B core antigen [Anti-HBc] and/or antibodies to hepatitis B surface antigen [Anti-HBs]) must be screened using real-time polymerase chain reaction (PCR) measurement of hepatitis B virus (HBV) deoxyribonucleic acid (DNA) levels. Those who are PCR positive will be excluded. EXCEPTION: Participants with serologic findings suggestive of HBV vaccination (Anti-HBs positivity as the only serologic marker) AND a known history of prior HBV vaccination, do not need to be tested for HBV DNA by PCR

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Janssen Research & Development, LLC Clinical Trial

Organizational Affiliation

Janssen Research & Development, LLC

Official's Role

Study Director

Facility Information:

Facility Name

Beijing Chaoyang Hospital

City

Beijing

ZIP/Postal Code

100020

Country

China

Facility Name

Peking Union Medical College Hospital

City

Beijing

ZIP/Postal Code

100032

Country

China

Facility Name

Peking University First Hospital

City

Beijing

ZIP/Postal Code

100034

Country

China

Facility Name

Beijing Chaoyang Hospital

City

Beijing

ZIP/Postal Code

100043

Country

China

Facility Name

Peking University Third Hospital

City

Beijing

ZIP/Postal Code

100083

Country

China

Facility Name

The First Hospital of Jilin University

City

Changchun

ZIP/Postal Code

130021

Country

China

Facility Name

The Third Xiangya Hospital, Central South University

City

Changsha

ZIP/Postal Code

410013

Country

China

Facility Name

West China Hospital, Si Chuan University

City

Chengdu

ZIP/Postal Code

610041

Country

China

Facility Name

Second Affiliated Hospital of Army Medical University

City

Chongqing

ZIP/Postal Code

400037

Country

China

Facility Name

Fujian Meidical University Union Hospital

City

Fuzhou

ZIP/Postal Code

350001

Country

China

Facility Name

Guangdong Provincial People's Hospital

City

Guangzhou

ZIP/Postal Code

510080

Country

China

Facility Name

The First Affiliated Hospital, Sun Yat-sen University

City

Guangzhou

ZIP/Postal Code

510080

Country

China

Facility Name

Nanfang Hospital

City

Guangzhou

ZIP/Postal Code

510515

Country

China

Facility Name

First affiliated Hospital of Zhejiang University

City

Hangzhou

ZIP/Postal Code

310020

Country

China

Facility Name

First Affiliated Hospital, Medical School of Zhejiang University

City

Hangzhou

ZIP/Postal Code

310020

Country

China

Facility Name

Harbin medical university cancer hospital

City

Harbin

ZIP/Postal Code

150081

Country

China

Facility Name

Nanjing Drum Tower Hospital

City

Nanjing

ZIP/Postal Code

210008

Country

China

Facility Name

Zhongda Hospital,Southeast University

City

Nanjing

ZIP/Postal Code

210009

Country

China

Facility Name

Jiangsu Province Hospital

City

Nanjing

ZIP/Postal Code

210029

Country

China

Facility Name

Shanghai Changzheng Hospital

City

Shanghai

ZIP/Postal Code

200003

Country

China

Facility Name

Ruijin Hospital, Shanghai Jiao Tong University

City

Shanghai

ZIP/Postal Code

200025

Country

China

Facility Name

Shanghai Zhongshan Hospital

City

Shanghai

ZIP/Postal Code

200032

Country

China

Facility Name

Renji Hospital, Shanghai Jiaotong University School of Medicine

City

ShangHai

ZIP/Postal Code

200127

Country

China

Facility Name

First Affiliated Hospital, SooChow University

City

Suzhou

ZIP/Postal Code

215006

Country

China

Facility Name

Tianjin cancer hospital

City

Tianjin

ZIP/Postal Code

300040

Country

China

Facility Name

Institute of Hematology & Blood Diseases Hospital

City

Tianjin

ZIP/Postal Code

300320

Country

China

Facility Name

The First Affiliated Hospital of Wenzhou Medical University

City

Wenzhou

ZIP/Postal Code

325000

Country

China

Facility Name

Tongji Hospital, Tongji Medical College of HUST

City

Wuhan

ZIP/Postal Code

430030

Country

China

Facility Name

Tangdu Hospital

City

Xian

ZIP/Postal Code

710038

Country

China

Facility Name

Henan Cancer Hospital

City

Zhengzhou

ZIP/Postal Code

450008

Country

China

Facility Name

Queen Mary Hospital, University of Hong Kong

City

Hong Kong

Country

Hong Kong

Facility Name

Inje University Busan Paik Hospital

City

Busan

ZIP/Postal Code

47392

Country

Korea, Republic of

Facility Name

Seoul National University Bundang Hospital

City

Gyeonggi-do

ZIP/Postal Code

13620

Country

Korea, Republic of

Facility Name

Gachon University Gil Medical Center

City

Incheon

ZIP/Postal Code

405-760

Country

Korea, Republic of

Facility Name

Chonnam National University Hwasun Hospital

City

Jeollanam-do

ZIP/Postal Code

58128

Country

Korea, Republic of

Facility Name

Samsung Medical Center

City

Seoul

ZIP/Postal Code

06351

Country

Korea, Republic of

Facility Name

The Catholic University of Korea Seoul St. Mary's Hospital

City

Seoul

ZIP/Postal Code

06591

Country

Korea, Republic of

Facility Name

Ulsan University Hospital

City

Ulsan

ZIP/Postal Code

44033

Country

Korea, Republic of

Facility Name

Hospital Ampang

City

Ampang

ZIP/Postal Code

68000

Country

Malaysia

Facility Name

Hospital Pulau Pinang

City

George Town

ZIP/Postal Code

10990

Country

Malaysia

Facility Name

Hospital Queen Elizabeth

City

Kota Kinabalu

ZIP/Postal Code

88586

Country

Malaysia

Facility Name

National Taiwan University Hospital

City

Taipei

ZIP/Postal Code

10048

Country

Taiwan

Facility Name

Taipei Veterans General Hospital

City

Taipei

ZIP/Postal Code

11217

Country

Taiwan

Facility Name

Chang Gung Memorial Hospital

City

Taoyuan

ZIP/Postal Code

33305

Country

Taiwan

12. IPD Sharing Statement

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