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An Open-label, Dose Escalation Study in Japanese Subjects With Relapsed/Refractory Multiple Myeloma Who Have Failed Prior Anti Myeloma Treatments

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ClinicalTrials.gov Identifier: NCT03828292
Recruitment Status : Not yet recruiting
First Posted : February 4, 2019
Last Update Posted : February 4, 2019
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
GSK2857916 is a first in class, antibody dependent cellular cytotoxicity (ADCC) enhanced, humanized immunoglobulin G1 (IgG1) antibody-drug conjugate (ADC) which binds specifically to B cell maturation antigen (BCMA) expressed on tumor cells of all subjects with multiple myeloma (MM). This is a Phase 1, open label, dose escalation study to investigate safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity and clinical activity of GSK2857916 given on a once every 21 days schedule. The starting dose is 2.5 milligrams per kilogram (mg/kg) and dose escalation will follow a 3+3 design. A maximum of 12 subjects will be enrolled, 6 each for 2.5 mg/kg cohort and 3.4 mg/kg cohort based on 3+3 design. Subjects will be treated until disease progression or unacceptable toxicity.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: GSK2857916 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Intervention Model: Single Group Assignment
Intervention Model Description: The dose-escalation model will follow a 3+3 design.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Open-Label, Dose Escalation Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Clinical Activity of the Antibody Drug Conjugate GSK2857916 in Japanese Participants With Relapsed/Refractory Multiple Myeloma
Estimated Study Start Date : February 7, 2019
Estimated Primary Completion Date : October 2, 2019
Estimated Study Completion Date : March 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arm Intervention/treatment
Experimental: Japanese subjects with relapsed/refractory multiple myeloma
Subjects will be administered escalating doses of GSK2857916 (2.5 mg/kg or 3.4 mg/kg) as an intravenous infusion on Day 1 of each 21-day cycle over 30 minutes. Subjects will be treated until disease progression, withdrawal of consent or until acceptable toxicity.
Drug: GSK2857916
GSK2857916 will be available as lyophilized powder 100 mg/vial in single-use vial for reconstitution. It will be administered at a calculated dose of 2.5 mg/kg or 3.4 mg/kg as an IV infusion on Day 1 of each cycle over 30 minutes.




Primary Outcome Measures :
  1. Number of subjects with dose limiting toxicities (DLTs) [ Time Frame: Day 1 to 21 of Cycle 1 (each cycle of 21 days) ]
    The number of subjects with DLTs will be reported.

  2. Number of subjects with adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: Approximately 1.1 years ]
    An AE is any untoward medical occurrence in a clinical study subject, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; Is a congenital anomaly/birth defect; important medical events that may jeopardize the subject or may require medical or surgical intervention to prevent one of the other outcomes listed; is associated with liver injury and impaired liver function.

  3. Number of subjects with abnormal hematology parameters [ Time Frame: Approximately 1.1 years ]
    Blood samples will be collected for the assessment of following hematology parameters: platelet count, red blood cell (RBC) count, white blood cell (WBC) count, reticulocyte count, hemoglobin, hematocrit, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), neutrophils, lymphocytes, monocytes, eosinophils and basophils.

  4. Number of subjects with abnormal clinical chemistry parameters [ Time Frame: Approximately 1.1 years ]
    Blood samples will be collected for the assessment of following clinical chemistry parameters: blood urea nitrogen (BUN), creatinine, glucose, sodium, magnesium, estimated glomerular filtration rate, potassium, chloride, total bicarbonate, calcium, phosphorus, albumin/creatinine ratio, aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma glutamyl transferase (GGT), alkaline phosphatase (ALP), creatine kinase, total and direct bilirubin, uric acid, albumin, total protein and lactate dehydrogenase.

  5. Number of subjects with abnormal urine parameters [ Time Frame: Approximately 1.1 years ]
    Urine samples will be collected for the assessment of following parameters: specific gravity, potential of hydrogen (pH); glucose, protein, blood and ketones by dipstick method. Microscopic examination will be performed if blood or protein is abnormal.

  6. Number of subjects with abnormal vital signs [ Time Frame: Approximately 1.1 years ]
    Vital signs will be measured after at least 5 minutes of rest and will include systolic and diastolic blood pressure, temperature and pulse rate.

  7. Number of subjects with abnormal electrocardiogram (ECG) findings [ Time Frame: Approximately 1.1 years ]
    Single 12-lead ECGs will be obtained using an automated ECG machine that calculates the heart rate and measure PR, QRS, QT and corrected QT (QTc) intervals.

  8. Number of subjects with abnormal physical examination [ Time Frame: Approximately 1.1 years ]
    A full physical examination will include assessments of the head, eyes, ears, nose, throat, skin, thyroid, lungs, cardiovascular, abdomen (liver and spleen), lymph nodes, and extremities

  9. Number of subjects with abnormal ocular examination findings [ Time Frame: Approximately 1.1 years ]
    Number of subjects with abnormal ocular examination findings will be reported.

  10. Eastern Cooperative Oncology Group (ECOG) scores [ Time Frame: Approximately 1.1 years ]
    The performance status of subjects will be assessed using the ECOG Scale.


Secondary Outcome Measures :
  1. Area under the plasma concentration time curve for GSK2857916 following single dose administration (AUC [0 to t]) [ Time Frame: Cycle1 (pre-dose, at end of infusion, 1, 3, 8, 24 hours post-infusion on Day1), Day8, Day15 (21-day cycle) ]
    Blood samples for pharmacokinetic analysis of GSK2857916 will be collected at the indicated time points.

  2. Area under the plasma concentration-time curve from time 0 to the end of dosing (AUC [0 to tau]) for GSK2857916 following single dose administration [ Time Frame: Cycle1 (pre-dose, at end of infusion, 1, 3, 8, 24 hours post-infusion on Day1), Day8, Day15 (21-day cycle) ]
    Blood samples for pharmacokinetic analysis of GSK2857916 will be collected at the indicated time points.

  3. Area under the plasma concentration-time curve from time 0 to infinite time (AUC [0 to inf]) for GSK2857916 following single dose administration [ Time Frame: Cycle1 (pre-dose, at end of infusion, 1, 3, 8, 24 hours post-infusion on Day1), Day8, Day15 (21-day cycle) ]
    Blood samples for pharmacokinetic analysis of GSK2857916 will be collected at the indicated time points.

  4. Maximum observed plasma concentration (Cmax) for GSK2857916 following single dose administration [ Time Frame: Cycle1 (pre-dose, at end of infusion, 1, 3, 8, 24 hours post-infusion on Day1), Day8, Day15 (21-day cycle) ]
    Blood samples for pharmacokinetic analysis of GSK2857916 will be collected at the indicated time points.

  5. Time to Cmax (Tmax) for GSK2857916 following single dose administration [ Time Frame: Cycle1 (pre-dose, at end of infusion, 1, 3, 8, 24 hours post-infusion on Day1), Day8, Day15 (21-day cycle) ]
    Blood samples for pharmacokinetic analysis of GSK2857916 will be collected at the indicated time points.

  6. Last time point where the concentration is above the limit of quantification (Tlast) for GSK2857916 following single dose administration [ Time Frame: Cycle1 (pre-dose, at end of infusion, 1, 3, 8, 24 hours post-infusion on Day1), Day8, Day15 (21-day cycle) ]
    Blood samples for pharmacokinetic analysis of GSK2857916 will be collected at the indicated time points.

  7. Systemic clearance (CL) for GSK2857916 following single dose administration [ Time Frame: Cycle1 (pre-dose, at end of infusion, 1, 3, 8, 24 hours post-infusion on Day1), Day8, Day15 (21-day cycle) ]
    Blood samples for pharmacokinetic analysis of GSK2857916 will be collected at the indicated time points.

  8. Volume of distribution at steady state (Vss) for GSK2857916 following single dose administration [ Time Frame: Cycle1 (pre-dose, at end of infusion, 1, 3, 8, 24 hours post-infusion on Day1), Day8, Day15 (21-day cycle) ]
    Blood samples for pharmacokinetic analysis of GSK2857916 will be collected at the indicated time points.

  9. Terminal phase elimination rate constant for GSK2857916 following single dose administration [ Time Frame: Cycle1 (pre-dose, at end of infusion, 1, 3, 8, 24 hours post-infusion on Day1), Day8, Day15 (21-day cycle) ]
    Blood samples for pharmacokinetic analysis of GSK2857916 will be collected at the indicated time points.

  10. Terminal phase half-life (T1/2) for GSK2857916 following single dose administration [ Time Frame: Cycle1 (pre-dose, at end of infusion, 1, 3, 8, 24 hours post-infusion on Day1), Day8, Day15 (21-day cycle) ]
    Blood samples for pharmacokinetic analysis of GSK2857916 will be collected at the indicated time points.

  11. Cmax of GSK2857916 following repeat dose administration [ Time Frame: Cycle1 (pre-dose, at end of infusion, 1, 3, 8, 24 hours post-infusion on Day1), Day8, Day15; Cycle 2 Day1, Cycle 3 Day1, Cycle 6 Day1, Cycle9 Day1, and Cycle12 Day1 (pre-dose, end of infusion); Cycle 16 Day1 (pre-dose) (each cycle of 21 days) ]
    Blood samples for pharmacokinetic analysis of GSK2857916 will be collected at the indicated time points.

  12. Trough plasma concentration (Ctrough) for GSK2857916 following repeat dose administration [ Time Frame: Cycle1 (pre-dose, at end of infusion, 1, 3, 8, 24 hours post-infusion on Day1), Day8, Day15; Cycle 2 Day1, Cycle 3 Day1, Cycle 6 Day1, Cycle9 Day1, and Cycle12 Day1 (pre-dose, end of infusion); Cycle 16 Day1 (pre-dose) (each cycle of 21 days) ]
    Blood samples for pharmacokinetic analysis of GSK2857916 will be collected at the indicated time points.

  13. Observed accumulation ratio for GSK2857916 following repeat dose administration [ Time Frame: Cycle1 (pre-dose, at end of infusion, 1, 3, 8, 24 hours post-infusion on Day1), Day8, Day15; Cycle 2 Day1, Cycle 3 Day1, Cycle 6 Day1, Cycle9 Day1, and Cycle12 Day1 (pre-dose, end of infusion); Cycle 16 Day1 (pre-dose) (each cycle of 21 days) ]
    Blood samples for pharmacokinetic analysis of GSK2857916 will be collected at the indicated time points.

  14. AUC (0 to t) for cys monomethyl auristatin F (cys-mcMMAF) following single dose administration [ Time Frame: Cycle1 (pre-dose, at end of infusion, 1, 3, 8, 24 hours post-infusion on Day1), Day8, Day15 (21-day cycle) ]
    Blood samples for pharmacokinetic analysis of cys-mcMMAF will be collected at the indicated time points.

  15. AUC (0 to tau) for cys-mcMMAF following single dose administration [ Time Frame: Cycle1 (pre-dose, at end of infusion, 1, 3, 8, 24 hours post-infusion on Day1), Day8, Day15 (21-day cycle) ]
    Blood samples for pharmacokinetic analysis of cys-mcMMAF will be collected at the indicated time points.

  16. AUC (0 to inf) for cys-mcMMAF following single dose administration [ Time Frame: Cycle1 (pre-dose, at end of infusion, 1, 3, 8, 24 hours post-infusion on Day1), Day8, Day15 (21-day cycle) ]
    Blood samples for pharmacokinetic analysis of cys-mcMMAF will be collected at the indicated time points.

  17. Cmax for cys-mcMMAF following single dose administration [ Time Frame: Cycle1 (pre-dose, at end of infusion, 1, 3, 8, 24 hours post-infusion on Day1), Day8, Day15 (21-day cycle) ]
    Blood samples for pharmacokinetic analysis of cys-mcMMAF will be collected at the indicated time points.

  18. Tmax for cys-mcMMAF following single dose administration [ Time Frame: Cycle1 (pre-dose, at end of infusion, 1, 3, 8, 24 hours post-infusion on Day1), Day8, Day15 (21-day cycle) ]
    Blood samples for pharmacokinetic analysis of cys-mcMMAF will be collected at the indicated time points.

  19. T1/2 for cys-mcMMAF following single dose administration [ Time Frame: Cycle1 (pre-dose, at end of infusion, 1, 3, 8, 24 hours post-infusion on Day1), Day8, Day15 (21-day cycle) ]
    Blood samples for pharmacokinetic analysis of cys-mcMMAF will be collected at the indicated time points.

  20. Concentration at end of infusion for cys-mcMMAF following repeat dose administration [ Time Frame: Cycle1 (pre-dose, at end of infusion, 1, 3, 8, 24 hours post-infusion on Day1), Day8, Day15; Cycle 2 Day1, Cycle 3 Day1, Cycle 6 Day1, Cycle9 Day1, and Cycle12 Day1 (pre-dose, end of infusion); Cycle 16 Day1 (pre-dose) (each cycle of 21 days) ]
    Blood samples for pharmacokinetic analysis of cys-mcMMAF will be collected at the indicated time points.

  21. Ctrough for cys-mcMMAF following repeat dose administration [ Time Frame: Cycle1 (pre-dose, at end of infusion, 1, 3, 8, 24 hours post-infusion on Day1), Day8, Day15; Cycle 2 Day1, Cycle 3 Day1, Cycle 6 Day1, Cycle9 Day1, and Cycle12 Day1 (pre-dose, end of infusion); Cycle 16 Day1 (pre-dose) (each cycle of 21 days) ]
    Blood samples for pharmacokinetic analysis of cys-mcMMAF will be collected at the indicated time points.

  22. Observed accumulation ratio for cys-mcMMAF following repeat dose administration [ Time Frame: Cycle1 (pre-dose, at end of infusion, 1, 3, 8, 24 hours post-infusion on Day1), Day8, Day15; Cycle 2 Day1, Cycle 3 Day1, Cycle 6 Day1, Cycle9 Day1, and Cycle12 Day1 (pre-dose, end of infusion); Cycle 16 Day1 (pre-dose) (each cycle of 21 days) ]
    Blood samples for pharmacokinetic analysis of cys-mcMMAF will be collected at the indicated time points.

  23. Number of subjects who develop anti-drug antibodies (ADAs) against GSK2857916 [ Time Frame: Approximately 1.1 years ]
    Serum samples will be collected from the subjects and analyzed for the presence of anti-GSK2857916 antibodies by a validated electrochemiluminescent immunoassay.

  24. Titers of anti-GSK2857916 antibodies [ Time Frame: Approximately 1.1 years ]
    Serum samples will be collected from the subjects and analyzed for the presence of anti-GSK2857916 antibodies by a validated electrochemiluminescent immunoassay.

  25. Overall response rate [ Time Frame: Approximately 1.1 years ]
    Overall response rate is defined as the percentage of subjects with a confirmed partial response or better, according to the International Myeloma Working Group (IMWG) response criteria, as assessed by the investigator.

  26. Clinical benefit rate [ Time Frame: Approximately 1.1 years ]
    Clinical benefit rate is defined as the percentage of subjects with a confirmed minimal response (MR) or better, according to the IMWG response criteria, as assessed by the investigator.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • Provide signed written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
  • Male or female, 20 years or older (at the time consent is obtained)
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
  • Histologically or cytologically confirmed diagnosis of multiple myeloma (MM) as defined according to IMWG 2014, criteria in a subject who fulfills all of the following: has undergone stem cell transplant, or is considered transplant ineligible, has been pretreated with at least 2 regimens including at least the 3 following classes of anti-myeloma drugs: alkylators, proteasome inhibitors and immunomodulators; has demonstrated progression on, or within 60 days of completion of the last therapy.
  • Has measurable disease with at least one of the following: serum M-protein >=0.5 grams per deciliter (g/dL) (>=5 grams per liter [g/L]); Urine M-protein >=200 milligrams (mg)/24 hours; Serum free light chain (FLC) assay: Involved FLC level >=10 mg/dL (>=100 mg/L) and an abnormal serum free light chain ratio (<0.26 or >1.65).
  • Subjects with a history of autologous stem cell transplant are eligible for study participation provided the following eligibility criteria are met:
  • Transplant was >100 days prior to study enrolment
  • No active infection.
  • Female subjects: Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. A female subject is eligible to participate if she is not pregnant or breast feeding, and at least one of the following conditions applies: Is not a woman of childbearing potential (WOCBP) or Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of <1% per year), preferably with low user dependency, during the treatment period and for at least 80 days after the last dose of study treatment and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period. The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study treatment. A WOCBP must have a negative highly sensitive serum pregnancy test (as required by local regulations) within 72 hours before the first dose of study treatment. The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.
  • Male subjects: Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Male subjects are eligible to participate if they agree to the following during the treatment period and for at least 140 days after last dose of study treatment: Refrain from donating sperm plus either: Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent; or must agree to use contraception/barrier as detailed: Agree to use a male condom and female partner to use an additional highly effective contraceptive method with a failure rate of <1% per year as when having sexual intercourse with a woman of childbearing potential who is not currently pregnant.
  • All prior treatment-related toxicities (defined by National Cancer Institute-Common Toxicity Criteria for Adverse Events (NCI-CTCAE), version 4.03, must be <=Grade 1 at the time of enrolment except for alopecia and Grade 2 peripheral neuropathy.
  • Adequate organ system function.

Exclusion Criteria

  • Systemic anti-tumor-therapy within 14 days, or plasmapheresis within 7 days prior to the first dose of study treatment.
  • Symptomatic amyloidosis, active 'polyneuropathy, organomegaly, endocrinopathy, myeloma protein, and skin changes' (POEMS) syndrome, active plasma cell leukemia at the time of screening.
  • Use of an investigational drug within 14 days or 5 half-lives, whichever is shorter, preceding the first dose of study treatment. Prior treatment with a monoclonal antibody within 30 days of receiving the first dose of study treatment. Prior BCMA targeted therapy.
  • History of an allogeneic stem cell transplant.
  • Current use of prohibited medications/device or planned use of any of these during the study period.
  • Current corneal epithelial disease except mild punctate keratopathy
  • Presence of active renal condition (infection, requirement for dialysis or any other condition that could affect subject's safety). Subjects with isolated proteinuria resulting from MM are eligible, provided they fulfil the required criteria.
  • Evidence of active mucosal or internal bleeding.
  • Any major surgery within the last 4 weeks.
  • Any serious and/or unstable pre-existing medical, psychiatric disorder, or other conditions (including laboratory abnormalities) that could interfere with subject's safety, obtaining informed consent or compliance to the study procedures.
  • Active infection requiring treatment (antibiotic, antiviral, or antifungal treatment).
  • Evidence of severe or uncontrolled systemic diseases.
  • Malignancies other than disease under study are excluded, except for any other malignancy from which the subject has been disease-free for more than 2 years and, in the opinion of the investigators and Medical Monitor, will not affect the evaluation of the effects of this clinical trial treatment on the currently targeted malignancy (MM).
  • Evidence of cardiovascular risk including any of the following:

    1. QTcF interval >=470 milliseconds (msecs) (the QT interval values must be corrected for heart rate by Fridericia's formula [QTcF])
    2. Evidence of current clinically significant uncontrolled arrhythmias, including clinically significant ECG abnormalities such as 2nd degree (Type II) or 3rd degree atrioventricular (AV) block.
    3. History of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting or bypass grafting within 6 months of Screening.
    4. Class III or IV heart failure as defined by the New York Heart Association functional classification system
    5. Uncontrolled hypertension
  • Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to GSK2857916 or any of the components of the study treatment.
  • Pregnant or lactating female or female who are interrupting lactation.
  • Known human Immunodeficiency virus (HIV) infection.
  • Presence of hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (HBsAb) or hepatitis B core antibody (HBcAb at Screening or within 3 months prior to first dose of study treatment).
  • Positive hepatitis C antibody test result or positive hepatitis C ribonucleic acid (RNA) test result at screening or within 3 months prior to first dose of study treatment. Subjects with positive hepatitis C antibody due to prior resolved disease can only be enrolled, if a confirmatory negative hepatitis C RNA test is obtained. Hepatitis RNA testing is optional and subjects with negative hepatitis C antibody test are not required to also undergo hepatitis C RNA testing.
  • Current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis. Stable chronic liver disease (including Gilbert's syndrome or asymptomatic gallstones) or hepatobiliary involvement of malignancy is acceptable if subject otherwise meets entry criteria.
  • Previously diagnosed with interstitial lung disease or current complication of interstitial lung disease.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03828292


Contacts
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Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com

Locations
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Japan
GSK Investigational Site Not yet recruiting
Aichi, Japan, 467-86
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    877-379-3718    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Not yet recruiting
Tokyo, Japan, 135-85
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    877-379-3718    GSKClinicalSupportHD@gsk.com   
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)

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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT03828292     History of Changes
Other Study ID Numbers: 207504
First Posted: February 4, 2019    Key Record Dates
Last Update Posted: February 4, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD for this study will be made available via the Clinical Study Data Request site.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints of the study.
Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
URL: http://clinicalstudydatarequest.com

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by GlaxoSmithKline:
Japanese
GSK2857916
Relapsed/Refractory Multiple Myeloma
dose-escalation
antibody drug conjugate

Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Immunoconjugates
Immunologic Factors
Physiological Effects of Drugs