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A Study to Evaluate Subcutaneous Daratumumab in Combination With Standard Multiple Myeloma Treatment Regimens

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ClinicalTrials.gov Identifier: NCT03412565
Recruitment Status : Recruiting
First Posted : January 26, 2018
Last Update Posted : August 15, 2019
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Tracking Information
First Submitted Date  ICMJE January 22, 2018
First Posted Date  ICMJE January 26, 2018
Last Update Posted Date August 15, 2019
Actual Study Start Date  ICMJE April 26, 2018
Estimated Primary Completion Date September 27, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 6, 2018)
  • D-VMP, D-Kd, and D-Rd Cohort: Overall Response Rate (ORR) [ Time Frame: 18 months after the last participant enrolled (approximately 2.5 years) ]
    The ORR is defined as the percentage of participants who achieve partial response (PR) or better according to international myeloma working group (IMWG) criteria, during or after study treatment for D-VMP, D-Kd and D-Rd cohorts. IMWG criteria for PR: greater than or equal to (>=) 50 percent (%) reduction of serum M-protein and reduction in 24-hour urinary M-protein by >=90% or to less than (<) 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 free light chain (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.
  • D-VRd Cohort: Very Good Partial Response (VGPR) or Better Rate [ Time Frame: 18 months after the last participant enrolled (approximately 2.5 years) ]
    The VGPR or better rate, defined as the percentage of participants achieving VGPR or better according IMWG criteria during or after the study treatment in Daratumumab + Bortezomib + Lenalidomide + Dexamethasone (D-VRd) cohort. IMWG criteria for VGPR: Serum and urine M-component detectable by immunofixation but not on electrophoresis, or >= 90 percent (%) reduction in serum M-protein plus urine M-protein <100 milligram per 24 hours (mg/24 hours).
Original Primary Outcome Measures  ICMJE
 (submitted: January 22, 2018)
  • D-VMP and D-Rd Cohort: Overall Response Rate (ORR) [ Time Frame: At least 6 months after the last participant enrolled (approximately 1.5 years) ]
    The ORR is defined as the percentage of participants who achieve partial response (PR) or better according to international myeloma working group (IMWG) criteria, during or after study treatment for D-VMP and D-Rd cohorts. IMWG criteria for PR: greater than or equal to (>=) 50 percent (%) reduction of serum M-protein and reduction in 24-hour urinary M-protein by >=90% or to less than (<) 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 free light chain (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.
  • D-VRd Cohort: Very Good Partial Response (VGPR) or Better Rate [ Time Frame: At least 6 months after the last participant enrolled (approximately 1.5 years) ]
    The VGPR or better rate, defined as the percentage of participants achieving VGPR or better according IMWG criteria during or after the study treatment in Daratumumab + Bortezomib + Lenalidomide + Dexamethasone (D-VRd) cohort. IMWG criteria for VGPR: Serum and urine M-component detectable by immunofixation but not on electrophoresis, or >= 90 percent (%) reduction in serum M-protein plus urine M-protein <100 milligram per 24 hours (mg/24 hours).
Change History Complete list of historical versions of study NCT03412565 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 1, 2019)
  • Maximum Observed Serum Concentrations (Cmax) of Daratumumab [ Time Frame: D-VRd: Day 4 of Cycles 1 and 4 and post treatment 4 weeks and at week 8; D-VMP and D-Rd: Day 4 of Cycles 1 and 2 and post treatment 4 weeks and at week 8; D-Kd: Day 4 of Cycles 1 and 3 and post treatment 4 weeks and at week 8 ]
    Cmax is defined as maximum concentration observed following daratumumab administration.
  • Minimum Observed Serum Concentrations (Cmin) of Daratumumab [ Time Frame: D-VRd: predose on Day 1 of Cycles 1, 3, and 4; D-VMP: predose on Day 1 of Cycles 1, 2, 3, 6 and 9; D-Rd: predose on Day 1 of Cycles 1, 3, 6, 9 and 12 and D-Kd: predose on Day 1 of Cycles 1, 3, 6, 9, and 12 ]
    Cmin is defined as the minimum concentration observed immediately before daratumumab administration.
  • Percentage of Participants with Infusion-Related Reactions (IRR) [ Time Frame: 18 months after the last participant enrolled (approximately 2.5 years) ]
    The Percentage of Participants with infusion reactions will be reported.
  • D-Kd, D-VMP, and D-Rd Cohort: Very Good Partial Response (VGPR) or Better Rate [ Time Frame: 18 months after the last participant enrolled (approximately 2.5 years) ]
    The VGPR or better rate, defined as the percentage of participants achieving VGPR or better rate according IMWG criteria during or after the study treatment for Daratumumab + Carfilzomib + Dexamethasone (D-Kd), Daratumumab + Bortezomib + Melphalan + Prednisone (D-VMP), and Daratumumab + Lenalidomide + Dexamethasone (D-Rd) cohorts. 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.
  • D-VRd Cohort: Overall Response Rate (ORR) [ Time Frame: 18 months after the last participant enrolled (approximately 2.5 years) ]
    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 for D-VRd cohort. IMWG criteria for PR: greater than or equal to (>=) 50 percent (%) reduction of serum M-protein and reduction in 24-hour urinary M-protein by >=90% or to less than (<) 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 free light chain (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 or Better Rate [ Time Frame: 18 months after the last participant enrolled (approximately 2.5 years) ]
    Complete response is based on serum M-Protein assessments. IMWG criteria for CR: Negative immunofixation on the serum and urine, and disappearance of any soft tissue plasmacytomas, and <5% PCs in bone marrow. Stringent complete response (sCR): CR plus normal FLC ratio, and absence of clonal PCs by immunohistochemistry, immunofluorescence or 2- to 4 color flow cytometry.
  • Duration of Response (DOR) [ Time Frame: 18 months after the last participant enrolled (approximately 2.5 years) ]
    Duration of response is defined as the time from the date of initial documented response (PR or better for D-Kd, D-VMP, D-Rd, and D-VRd cohorts) to the date of first documented evidence of progressive disease or death due to progressive disease (PD).
  • Number of Participants with Anti-Drug Antibodies Against Daratumumab or Recombinant Human Hyaluronidase (rHuPH20) [ Time Frame: Up to 8 weeks after the last dose of study drug (approximately 1 year) ]
    Participants with anti-drug antibodies against daratumumab or rHuPH20 will be analyzed.
  • D-Kd, D-VMP, and D-Rd Cohorts: Percentage of Participants who are Minimal Residual Disease (MRD) Negative [ Time Frame: 18 months after the last participant enrolled (approximately 2.5 years) ]
    Percentage of participants who are MRD negative will be assessed for D-Kd, D-VMP, and D-Rd cohorts. MRD negative is defined as less than (<) 0.01% abnormal population counts to total event counts when measured by flow.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 22, 2018)
  • Maximum Observed Serum Concentrations (Cmax) of Daratumumab [ Time Frame: D-VRd: Day 4 of Cycles 1 and 4 and post treatment weeks 4 and 8; D-VMP: Day 4 of Cycles 1 and 2 and post treatment weeks 4 and 8; D-VRd: Day 4 of Cycles 1 and 2 and post treatment weeks 4 and 8 ]
    Cmax is defined as maximum concentration observed following daratumumab administration.
  • Minimum Observed Serum Concentrations (Cmin) of Daratumumab [ Time Frame: D-VRd: predose on Day 1 of Cycles 1, 3, and 4; D-VMP: predose on Day 1 of Cycles 1, 2, 3, 6 and 9 and D-Rd: predose on Day 1 of Cycles 1, 3, 6, 9 and 12 ]
    Cmin is defined as the minimum concentration observed immediately before daratumumab administration.
  • Percentage of Participants with Infusion-Related Reactions (IRR) [ Time Frame: At least 6 months after last participant enrolled (approximately 1.5 years) ]
    The Percentage of Participants with infusion reactions will be reported.
  • D-VMP and D-Rd Cohort: Very Good Partial Response (VGPR) or Better Rate [ Time Frame: At least 6 months after the last participant enrolled (approximately 1.5 years) ]
    The VGPR or better rate, defined as the percentage of participants achieving VGPR or better rate according IMWG criteria during or after the study treatment for Daratumumab + Bortezomib + Melphalan + Prednisone (D-VMP) and Daratumumab + Lenalidomide + Dexamethasone (D-Rd) cohorts. 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.
  • D-VRd Cohort: Overall Response Rate (ORR) [ Time Frame: At least 6 months after the last participant enrolled (approximately 1.5 years) and 18 months after the last participant enrolled (approximately 2.5 years) ]
    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 for D-VRd cohort. IMWG criteria for PR: greater than or equal to (>=) 50 percent (%) reduction of serum M-protein and reduction in 24-hour urinary M-protein by >=90% or to less than (<) 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 free light chain (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 or Better Rate [ Time Frame: At least 6 months after the last participant enrolled (approximately 1.5 years) and 18 months after the last participant enrolled (approximately 2.5 years) ]
    Complete response is based on serum M-Protein assessments. IMWG criteria for CR: Negative immunofixation on the serum and urine, and disappearance of any soft tissue plasmacytomas, and <5% PCs in bone marrow. Stringent complete response (sCR): CR plus normal FLC ratio, and absence of clonal PCs by immunohistochemistry, immunofluorescence or 2- to 4 color flow cytometry.
  • Duration of Response (DOR) [ Time Frame: At least 6 months after the last participant enrolled (approximately 1.5 years) and 18 months after the last participant enrolled (approximately 2.5 years) ]
    Duration of response is defined as the time from the date of initial documented response (PR or better for D-VMP and D-Rd cohorts, or VGPR or better for D-VRd cohort) to the date of first documented evidence of progressive disease or death due to progressive disease (PD).
  • Number of Participants with Anti-Drug Antibodies Against Daratumumab or Recombinant Human Hyaluronidase (rHuPH20) [ Time Frame: Up to 8 weeks after the last dose of study drug (approximately 1 year) ]
    Participants with anti-drug antibodies against daratumumab or rHuPH20 will be analyzed.
  • D-VMP and D-Rd Cohorts: Percentage of Participants who are Minimal Residual Disease (MRD) Negative [ Time Frame: At least 6 months after the last participant enrolled (approximately 1.5 years) and 18 months after the last participant enrolled (approximately 2.5 years) ]
    Percentage of participants who are MRD negative will be assessed for D-VMP and D-Rd cohorts. MRD negative is defined as less than (<) 0.01% abnormal population counts to total event counts when measured by flow.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate Subcutaneous Daratumumab in Combination With Standard Multiple Myeloma Treatment Regimens
Official Title  ICMJE A Multicenter Phase 2 Study to Evaluate Subcutaneous Daratumumab in Combination With Standard Multiple Myeloma Treatment Regimens
Brief Summary The purpose of this study is to evaluate the clinical benefit of subcutaneous (SC) daratumumab administered in combination with standard multiple myeloma (MM) regimens in participants with MM as measured by overall response rate (ORR) or very good partial response (VGPR) or better rate.
Detailed Description The hypothesis is that the addition of daratumumab administered SC to standard MM regimens will improve responses compared to response data observed in completed phase 3 studies without daratumumab. Disease evaluations will include measurements of myeloma proteins, bone marrow examinations, skeletal surveys, assessment of extramedullary plasmacytomas, and measurements of serum calcium corrected for albumin. Safety will be measured by adverse events, laboratory test results, electrocardiogram (ECGs), vital sign measurements, physical examination findings, SC injection-site assessments, and assessment of Eastern Cooperative Oncology Group (ECOG) performance status score. Study will consist of 3 phases (screening, treatment and follow-up) and duration of study is approximately 3 years.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Multiple Myeloma
Intervention  ICMJE
  • Drug: Daratumumab
    Daratumumab will be administered at a dose of 1800 mg by SC injection in Cycles 1 to 4 in D-VRd cohort and until documented progression of disease, unacceptable toxicity, or end of study for D-VMP, D-Rd and D-Kd cohorts.
  • Drug: Bortezomib
    Bortezomib will be administered as 1.3 mg/m^2 SC injection in Cycles 1 to 4 in D-VRd cohort and in Cycles 1 to 9 in D-VMP cohort.
  • Drug: Lenalidomide
    Lenalidomide will be administered as 25 mg capsule orally in Cycles 1 to 4 in D-VRd cohort and in all Cycles until documented progression of disease, unacceptable toxicity, or end of study in D-Rd cohort.
  • Drug: Dexamethasone
    Dexamethasone will be administered as 20 mg orally or intravenously in Cycles 1 to 4 in D-VRd cohort; 40 mg orally or intravenously in all cycles and thereafter until documented progression of disease, unacceptable toxicity, or end of study in D-Rd and D-Kd cohort.
  • Drug: Melphalan
    Melphalan will be administered as 9 mg/m^2 orally in Cycles 1 to 9.
  • Drug: Prednisone
    Prednisone will be administered as 60 mg/m^2 orally in cycles 1 to 9.
  • Drug: Carfilzomib
    Carfilzomib will be administered as 20 mg/m^2 IV on Day 1 of Cycle 1 only then 70 mg/m^2 IV on Days 8 and 15 of Cycle 1 and Days 1, 8 and 15 of Cycle 2 and thereafter until documented progression of disease, unacceptable toxicity, or end of study in D-Kd cohort.
Study Arms  ICMJE
  • Experimental: Daratumumab(D)+Bortezomib+Lenalidomide+Dexamethasone (D-VRd)
    Participants will receive daratumumab 1800 milligram (mg) by subcutaneous (SC) injection on Days 1, 8 and 15 of Cycles 1 to 3 (each cycle of 21 days) and on Day 1 of Cycle 4; bortezomib 1.3 milligram per square meter (mg/m^2) SC injection on Days 1, 4, 8 and 11 of Cycles 1 to 4; lenalidomide 25 mg orally on Day 1 through Day 14 of Cycles 1 to 4 and dexamethasone 20 mg orally or intravenously on Days 1, 2 ,8, 9, 15 and 16 of Cycle 1 to 4.
    Interventions:
    • Drug: Daratumumab
    • Drug: Bortezomib
    • Drug: Lenalidomide
    • Drug: Dexamethasone
  • Experimental: D + Bortezomib + Melphalan + Prednisone (D-VMP)
    Participants will receive daratumumab 1800 mg by SC injection on Days 1, 8, 15, 22, 29 and 36 of Cycle 1 then on Days 1 and 22 in Cycles 2 to 9 and Day 1 of Cycle 10 and thereafter until documented progression of disease, unacceptable toxicity, or end of study; bortezomib 1.3 mg/m^2 SC injection on Day 1, 4, 8, 11, 22, 25, 29 and 32 of Cycle 1 and on Days 1, 8, 22 and 29 of Cycles 2 to 9; melphalan 9 mg/m^2 orally on Day 1 through Day 4 of Cycles 1 to 9; prednisone 60 mg/m^2 orally on Days 1 to 4 of cycles 1 to 9.
    Interventions:
    • Drug: Daratumumab
    • Drug: Bortezomib
    • Drug: Melphalan
    • Drug: Prednisone
  • Experimental: Daratumumab + Lenalidomide + Dexamethasone (D-Rd)
    Participants will receive daratumumab 1800 mg by SC injection on Days 1, 8, 15 and 22 of Cycles 1 and 2 then on Day 1 and 15 of Cycles 3 to 6 and on Day 1 of Cycle 7 and thereafter until documented progression of disease, unacceptable toxicity, or end of study; lenalidomide 25 mg orally on Day 1 through Day 21 of each cycle until documented progression of disease, unacceptable toxicity, or end of study and dexamethasone 40 mg orally or intravenously weekly until documented progression of disease, unacceptable toxicity, or end of study.
    Interventions:
    • Drug: Daratumumab
    • Drug: Lenalidomide
    • Drug: Dexamethasone
  • Experimental: Daratumumab + Carfilzomib + Dexamethasone (D-Kd)
    Participants will receive daratumumab 1800 mg by SC injection on Days 1, 8, 15 and 22 of Cycles 1 and 2 (each cycle is of 28 days) then on Day 1 and 15 of Cycles 3 to 6 and on Day 1 of Cycle 7 and thereafter until documented progression of disease, unacceptable toxicity, or end of study; Carfilzomib 20 mg/m^2 intravenously (IV) on Day 1 of Cycle 1 only then 70 mg/m^2 IV on Days 8 and 15 of Cycle 1 and Days 1, 8 and 15 of Cycle 2 and thereafter until documented progression of disease, unacceptable toxicity, or end of study and dexamethasone 40 mg orally or IV weekly for Cycles 1-9 then on Days 1, 8, 15 of each cycle for Cycles 10 and thereafter until documented progression of disease, unacceptable toxicity, or end of study.
    Interventions:
    • Drug: Daratumumab
    • Drug: Dexamethasone
    • Drug: Carfilzomib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 25, 2019)
240
Original Estimated Enrollment  ICMJE
 (submitted: January 22, 2018)
180
Estimated Study Completion Date  ICMJE November 26, 2021
Estimated Primary Completion Date September 27, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Multiple myeloma diagnosed according to the International Myeloma Working Group (IMWG) diagnostic criteria
  • Measurable, secretory disease as defined by any of the following:

    1. Serum monoclonal paraprotein (M-protein) level greater than or equal to (>=) 1.0 gram per deciliter (g/dL); or
    2. Urine M-protein level >= 200 milligram per 24 hours (mg/24 hours); or
    3. Light chain multiple myeloma (MM), for participants without measurable disease in the serum or urine: serum Immunoglobulin (Ig) free light chain (FLC) >= 10 mg/dL and abnormal FLC ratio
  • Meets one of the sets of the following criteria:

    1. For Daratumumab + bortezomib + lenalidomide + dexamethasone (D-VRd) and Daratumumab + bortezomib + melphalan + prednisone + dexamethasone (D-VMP) regimen: newly diagnosed myeloma
    2. For Daratumumab + lenalidomide + dexamethasone (D-Rd) and Daratumumab + Carfilzomib + Dexamethasone (D-Kd) regimen: relapsed or refractory disease
    3. D-Kd cohort: Participants must have received only 1 prior line of therapy for MM which included at least 2 consecutive cycles of lenalidomide therapy
  • Eastern Cooperative Oncology Group (ECOG) Performance Status grade of 0, 1, or 2
  • During the study, and for 3 months after receiving the last dose of daratumumab, a woman must agree not to donate eggs (ova, oocytes) and men must agree not to donate sperm for the purposes of assisted reproduction

Exclusion Criteria:

  • History of malignancy (other than MM) unless all treatment of that malignancy was completed at least 2 years before consent and the participant has no evidence of disease further exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or breast, or other non-invasive lesion, 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
  • Exhibits clinical signs of meningeal involvement of MM
  • Either of the following: a) Chronic obstructive pulmonary disease with a forced expiratory volume in 1 second (FEV1) is less than (<) 50 percentage (%) of predicted normal b) Moderate or severe persistent asthma, or a history of asthma within the last 2 years, or currently has uncontrolled asthma of any classification c) For D-Kd cohort: Known infiltrative pulmonary disease or known pulmonary hypertension
  • Any of the following: a) Known to be seropositive for human immunodeficiency virus; b) Seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen [HBsAg]). Participants with resolved infection (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) DNA levels. Those who are polymerase chain reaction (PCR) positive will be excluded
  • Known to be seropositive for hepatitis C (Anti-HCV antibody positive or HCV-RNA quantitation positive) except in the setting of a sustained virologic response [SVR], defined as aviremia at least 12 weeks after completion of antiviral therapy
  • For D-Kd cohort only: Transthoracic echocardiogram showing left ventricular ejection fraction (LVEF) <40%; uncontrolled hypertension, defined as an average systolic blood pressure greater than (>)159 millimeters of mercury (mmHg) or diastolic >99 mmHg despite optimal treatment
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Study Contact 844-434-4210 JNJ.CT@sylogent.com
Listed Location Countries  ICMJE Brazil,   Czechia,   France,   Germany,   Israel,   Japan,   Korea, Republic of,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03412565
Other Study ID Numbers  ICMJE CR108435
2017-004203-41 ( EudraCT Number )
54767414MMY2040 ( Other Identifier: Janssen Research & Development, LLC )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Janssen Research & Development, LLC
Study Sponsor  ICMJE Janssen Research & Development, LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
PRS Account Janssen Research & Development, LLC
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP