Last updated: 08/01/2025 12:30:14

An open-label, dose escalation study in Japanese participants with relapsed/refractory multiple myeloma who have failed prior anti myeloma treatments

GSK study ID
207504
See study documents
Clinicaltrials.gov ID
NCT03828292
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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
Trial description: Belantamab mafodotin (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 participants with multiple myeloma. This is a Phase 1, open label, dose escalation study to investigate safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity and clinical activity of GSK2857916 when given as monotherapy (Part 1) or given as combination therapy (Part 2). Dose escalation will follow a 3+3 design.
Primary purpose:
Treatment
Trial design:
Sequential Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:

Part 1: Number of participants with dose limiting toxicities (DLTs)

Timeframe: Day 1 to 21 of Cycle 1 (each cycle of 21 days)

Part 2: Arm A: Number of participants with DLTs

Timeframe: Day 1 to 21 of Cycle 1 (each cycle of 21 days)

Part 2: Arm B: Number of participants with DLTs

Timeframe: Day 1 to 28 of Cycle 1 (each cycle of 28 days)

Part 1 and Part 2: Number of participants with adverse events (AEs) and serious adverse events (SAEs)

Timeframe: Up to approximately 2.2 years

Part 1 and Part 2: Number of participants with abnormal hematology, clinical chemistry, urinalysis parameters

Timeframe: Up to approximately 2.2 years

Part 1 and Part 2: Number of participants with abnormal vital signs

Timeframe: Up to approximately 2.2 years

Part 1 and Part 2: Number of participants with abnormal electrocardiogram (ECG) findings

Timeframe: Up to approximately 2.2 years

Part 1 and Part 2: Number of participants with abnormal physical examination findings

Timeframe: Up to approximately 2.2 years

Part 1 and Part 2: Number of participants with abnormal ocular examination findings

Timeframe: Up to approximately 2.2 years

Part 1 and Part 2: Mean Eastern Cooperative Oncology Group (ECOG) scores

Timeframe: Up to approximately 2.2 years

Secondary outcomes:

Part 1: Area under the plasma concentration time curve from time 0 to the time of the last quantifiable concentration (AUC [0 to t]) for GSK2857916 following single dose administration

Timeframe: Cycle1 Day1 (pre-dose, end of infusion, 1, 3, 8, 24 hours post-infusion), Day8, Day15 (21-day cycle)

Part 2: Arm A: AUC (0 to t) for GSK2857916 following single dose administration

Timeframe: Cycle1 Day1 (pre-dose, end of infusion, 2 hours after start of infusion, 24 hours after start of infusion); Cycle1 Day4; one sample between Cycle1 Day8 to Day15 (21-day cycle)

Part 2: Arm B: AUC (0 to t) for GSK2857916 following single dose administration

Timeframe: Cycle1 Day1 (pre-dose, end of infusion, 2 hours after start of infusion, 24 hours after start of infusion); Cycle1 Day4; one sample between Cycle1 Day8 to Day15 (28-day cycle)

Part 1: 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

Timeframe: Cycle1 Day1 (pre-dose, end of infusion, 1, 3, 8, 24 hours post-infusion), Day8, Day15 (21-day cycle)

Part 2: Arm A: AUC (0 to tau) for GSK2857916 following single dose administration

Timeframe: Cycle1 Day1 (pre-dose, end of infusion, 2 hours after start of infusion, 24 hours after start of infusion); Cycle1 Day4; one sample between Cycle1 Day8 to Day15 (21-day cycle)

Part 2: Arm B: AUC (0 to tau) for GSK2857916 following single dose administration

Timeframe: Cycle1 Day1 (pre-dose, end of infusion, 2 hours after start of infusion, 24 hours after start of infusion); Cycle1 Day4; one sample between Cycle1 Day8 to Day15 (28-day cycle)

Part 1: Area under the plasma concentration-time curve from time 0 to infinite time (AUC [0 to inf]) for GSK2857916 following single dose administration

Timeframe: Cycle1 Day1 (pre-dose, end of infusion, 1, 3, 8, 24 hours post-infusion), Day8, Day15 (21-day cycle)

Part 2: Arm A: AUC (0 to inf) for GSK2857916 following single dose administration

Timeframe: Cycle1 Day1 (pre-dose, end of infusion, 2 hours after start of infusion, 24 hours after start of infusion); Cycle1 Day4; one sample between Cycle1 Day8 to Day15 (21-day cycle)

Part 2: Arm B: AUC (0 to inf) for GSK2857916 following single dose administration

Timeframe: Cycle1 Day1 (pre-dose, end of infusion, 2 hours after start of infusion, 24 hours after start of infusion); Cycle1 Day4; one sample between Cycle1 Day8 to Day15 (28-day cycle)

Part 1: Maximum observed plasma concentration (Cmax) for GSK2857916 following single dose administration

Timeframe: Cycle1 Day1 (pre-dose, end of infusion, 1, 3, 8, 24 hours post-infusion), Day8, Day15 (21-day cycle)

Part 2: Arm A: Cmax for GSK2857916 following single dose administration

Timeframe: Cycle1 Day1 (pre-dose, end of infusion, 2 hours after start of infusion, 24 hours after start of infusion); Cycle1 Day4; one sample between Cycle1 Day8 to Day15 (21-day cycle)

Part 2: Arm B: Cmax for GSK2857916 following single dose administration

Timeframe: Cycle1 Day1 (pre-dose, end of infusion, 2 hours after start of infusion, 24 hours after start of infusion); Cycle1 Day4; one sample between Cycle1 Day8 to Day15 (28-day cycle)

Part 1: Time to Cmax (Tmax) for GSK2857916 following single dose administration

Timeframe: Cycle1 Day1 (pre-dose, end of infusion, 1, 3, 8, 24 hours post-infusion), Day8, Day15 (21-day cycle)

Part 2: Arm A: Tmax for GSK2857916 following single dose administration

Timeframe: Cycle1 Day1 (pre-dose, end of infusion, 2 hours after start of infusion, 24 hours after start of infusion); Cycle1 Day4; one sample between Cycle1 Day8 to Day15 (21-day cycle)

Part 2: Arm B: Tmax for GSK2857916 following single dose administration

Timeframe: Cycle1 Day1 (pre-dose, end of infusion, 2 hours after start of infusion, 24 hours after start of infusion); Cycle1 Day4; one sample between Cycle1 Day8 to Day15 (28-day cycle)

Part 1: Systemic clearance (CL) for GSK2857916 following single dose administration

Timeframe: Cycle1 Day1 (pre-dose, end of infusion, 1, 3, 8, 24 hours post-infusion), Day8, Day15 (21-day cycle)

Part 2: Arm A: CL for GSK2857916 following single dose administration

Timeframe: Cycle1 Day1 (pre-dose, end of infusion, 2 hours after start of infusion, 24 hours after start of infusion); Cycle1 Day4; one sample between Cycle1 Day8 to Day15 (21-day cycle)

Part 2: Arm B: CL for GSK2857916 following single dose administration

Timeframe: Cycle1 Day1 (pre-dose, end of infusion, 2 hours after start of infusion, 24 hours after start of infusion); Cycle1 Day4; one sample between Cycle1 Day8 to Day15 (28-day cycle)

Part 1: Volume of distribution at steady state (Vss) for GSK2857916 following single dose administration

Timeframe: Cycle1 Day1 (pre-dose, end of infusion, 1, 3, 8, 24 hours post-infusion), Day8, Day15 (21-day cycle)

Part 2: Arm A: Vss for GSK2857916 following single dose administration

Timeframe: Cycle1 Day1 (pre-dose, end of infusion, 2 hours after start of infusion, 24 hours after start of infusion); Cycle1 Day4; one sample between Cycle1 Day8 to Day15 (21-day cycle)

Part 2: Arm B: Vss for GSK2857916 following single dose administration

Timeframe: Cycle1 Day1 (pre-dose, end of infusion, 2 hours after start of infusion, 24 hours after start of infusion); Cycle1 Day4; one sample between Cycle1 Day8 to Day15 (28-day cycle)

Part 1: Terminal phase half-life (T1/2) for GSK2857916 following single dose administration

Timeframe: Cycle1 Day1 (pre-dose, end of infusion, 1, 3, 8, 24 hours post-infusion), Day8, Day15 (21-day cycle)

Part 2: Arm A: T1/2 for GSK2857916 following single dose administration

Timeframe: Cycle1 Day1 (pre-dose, end of infusion, 2 hours after start of infusion, 24 hours after start of infusion); Cycle1 Day4; one sample between Cycle1 Day8 to Day15 (21-day cycle)

Part 2: Arm B: T1/2 for GSK2857916 following single dose administration

Timeframe: Cycle1 Day1 (pre-dose, end of infusion, 2 hours after start of infusion, 24 hours after start of infusion); Cycle1 Day4; one sample between Cycle1 Day8 to Day15 (28-day cycle)

Part 1: Concentration at the end of infusion of GSK2857916 following repeat dose administration

Timeframe: Cycle1 Day1 (pre-dose, end of infusion, 1, 3, 8, 24 hours post-infusion), 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) (21-day cycle)

Part 2: Arm A: Concentration at the end of infusion of GSK2857916 following repeat dose administration

Timeframe: Up to approximately 2.2 years

Part 2: Arm B: Concentration at the end of infusion of GSK2857916 following repeat dose administration

Timeframe: Up to approximately 2.2 years

Part 1: Trough plasma concentration (Ctrough) for GSK2857916 following repeat dose administration

Timeframe: Cycle1 Day1 (pre-dose, end of infusion, 1, 3, 8, 24 hours post-infusion), 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) (21-day cycle)

Part 2: Arm A: Ctrough for GSK2857916 following repeat dose administration

Timeframe: Up to approximately 2.2 years

Part 2: Arm B: Ctrough for GSK2857916 following repeat dose administration

Timeframe: Up to approximately 2.2 years

Part 1: Observed accumulation ratio for GSK2857916 following repeat dose administration

Timeframe: Cycle1 Day1 (pre-dose, end of infusion, 1, 3, 8, 24 hours post-infusion), 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) (21-day cycle)

Part 2: Arm A: Observed accumulation ratio for GSK2857916 following repeat dose administration

Timeframe: Up to approximately 2.2 years

Part 2: Arm B: Observed accumulation ratio for GSK2857916 following repeat dose administration

Timeframe: Up to approximately 2.2 years

Part 1: AUC (0 to t) for Cysteine maleimidocaproyl monomethyl auristatin F (cys-mcMMAF) following single dose administration

Timeframe: Cycle1 Day1 (pre-dose, end of infusion, 1, 3, 8, 24 hours post-infusion), Day8, Day15 (21-day cycle)

Part 2: Arm A: AUC (0 to t) for cys-mcMMAF following single dose administration

Timeframe: Cycle1 Day1 (pre-dose, end of infusion, 2 hours after start of infusion, 24 hours after start of infusion); Cycle1 Day4; one sample between Cycle1 Day8 to Day15 (21-day cycle)

Part 2: Arm B: AUC (0 to t) for cys-mcMMAF following single dose administration

Timeframe: Cycle1 Day1 (pre-dose, end of infusion, 2 hours after start of infusion, 24 hours after start of infusion); Cycle1 Day4; one sample between Cycle1 Day8 to Day15 (28-day cycle)

Part 1: AUC (0 to tau) for cys-mcMMAF following single dose administration

Timeframe: Cycle1 Day1 (pre-dose, end of infusion, 1, 3, 8, 24 hours post-infusion), Day8, Day15 (21-day cycle)

Part 2: Arm A: AUC (0 to tau) for cys-mcMMAF following single dose administration

Timeframe: Cycle1 Day1 (pre-dose, end of infusion, 2 hours after start of infusion, 24 hours after start of infusion); Cycle1 Day4; one sample between Cycle1 Day8 to Day15 (21-day cycle)

Part 2: Arm B: AUC (0 to tau) for cys-mcMMAF following single dose administration

Timeframe: Cycle1 Day1 (pre-dose, end of infusion, 2 hours after start of infusion, 24 hours after start of infusion); Cycle1 Day4; one sample between Cycle1 Day8 to Day15 (28-day cycle)

Part 1: AUC (0 to inf) for cys-mcMMAF following single dose administration

Timeframe: Cycle1 Day1 (pre-dose, end of infusion, 1, 3, 8, 24 hours post-infusion), Day8, Day15 (21-day cycle)

Part 2: Arm A: AUC (0 to inf) for cys-mcMMAF following single dose administration

Timeframe: Cycle1 Day1 (pre-dose, end of infusion, 2 hours after start of infusion, 24 hours after start of infusion); Cycle1 Day4; one sample between Cycle1 Day8 to Day15 (21-day cycle)

Part 2: Arm B: AUC (0 to inf) for cys-mcMMAF following single dose administration

Timeframe: Cycle1 Day1 (pre-dose, end of infusion, 2 hours after start of infusion, 24 hours after start of infusion); Cycle1 Day4; one sample between Cycle1 Day8 to Day15 (28-day cycle)

Part 1: Cmax for cys-mcMMAF following single dose administration

Timeframe: Cycle1 Day1 (pre-dose, end of infusion, 1, 3, 8, 24 hours post-infusion), Day8, Day15 (21-day cycle)

Part 2: Arm A: Cmax for cys-mcMMAF following single dose administration

Timeframe: Cycle1 Day1 (pre-dose, end of infusion, 2 hours after start of infusion, 24 hours after start of infusion); Cycle1 Day4; one sample between Cycle1 Day8 to Day15 (21-day cycle)

Part 2: Arm B: Cmax for cys-mcMMAF following single dose administration

Timeframe: Cycle1 Day1 (pre-dose, end of infusion, 2 hours after start of infusion, 24 hours after start of infusion); Cycle1 Day4; one sample between Cycle1 Day8 to Day15 (28-day cycle)

Part 1: Tmax for cys-mcMMAF following single dose administration

Timeframe: Cycle1 Day1 (pre-dose, end of infusion, 1, 3, 8, 24 hours post-infusion), Day8, Day15 (21-day cycle)

Part 2: Arm A: Tmax for cys-mcMMAF following single dose administration

Timeframe: Cycle1 Day1 (pre-dose, end of infusion, 2 hours after start of infusion, 24 hours after start of infusion); Cycle1 Day4; one sample between Cycle1 Day8 to Day15 (21-day cycle)

Part 2: Arm B: Tmax for cys-mcMMAF following single dose administration

Timeframe: Cycle1 Day1 (pre-dose, end of infusion, 2 hours after start of infusion, 24 hours after start of infusion); Cycle1 Day4; one sample between Cycle1 Day8 to Day15 (28-day cycle)

Part 1: T1/2 for cys-mcMMAF following single dose administration

Timeframe: Cycle1 Day1 (pre-dose, end of infusion, 1, 3, 8, 24 hours post-infusion), Day8, Day15 (21-day cycle)

Part 2: Arm A: T1/2 for cys-mcMMAF following single dose administration

Timeframe: Cycle1 Day1 (pre-dose, end of infusion, 2 hours after start of infusion, 24 hours after start of infusion); Cycle1 Day4; one sample between Cycle1 Day8 to Day15 (21-day cycle)

Part 2: Arm B: T1/2 for cys-mcMMAF following single dose administration

Timeframe: Cycle1 Day1 (pre-dose, end of infusion, 2 hours after start of infusion, 24 hours after start of infusion); Cycle1 Day4; one sample between Cycle1 Day8 to Day15 (28-day cycle)

Part 1: Concentration at end of infusion for cys-mcMMAF following repeat dose administration

Timeframe: Cycle1 Day1 (pre-dose, end of infusion, 1, 3, 8, 24 hours post-infusion), 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) (21-day cycle)

Part 2: Arm A: Concentration at end of infusion for cys-mcMMAF following repeat dose administration

Timeframe: Up to approximately 2.2 years

Part 2: Arm B: Concentration at end of infusion for cys-mcMMAF following repeat dose administration

Timeframe: Up to approximately 2.2 years

Part 1: Ctrough for cys-mcMMAF following repeat dose administration

Timeframe: Cycle1 Day1 (pre-dose, end of infusion, 1, 3, 8, 24 hours post-infusion), 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) (21-day cycle)

Part 2: Arm A: Ctrough for cys-mcMMAF following repeat dose administration

Timeframe: Up to approximately 2.2 years

Part 2: Arm B: Ctrough for cys-mcMMAF following repeat dose administration

Timeframe: Up to approximately 2.2 years

Part 1: Observed accumulation ratio for cys-mcMMAF following repeat dose administration

Timeframe: Cycle1 Day1 (pre-dose, end of infusion, 1, 3, 8, 24 hours post-infusion), 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) (21-day cycle)

Part 2: Arm A: Observed accumulation ratio for cys-mcMMAF following repeat dose administration

Timeframe: Up to approximately 2.2 years

Part 2: Arm B: Observed accumulation ratio for cys-mcMMAF following repeat dose administration

Timeframe: Up to approximately 2.2 years

Part 1 and Part 2: Number of participants who develop anti-drug antibodies (ADAs) against GSK2857916

Timeframe: Up to approximately 2.2 years

Part 1 and Part 2: Titers of anti-GSK2857916 antibodies

Timeframe: Up to approximately 2.2 years

Part 1 and Part 2: Overall response rate

Timeframe: Up to approximately 2.2 years

Part 1 and Part 2: Clinical benefit rate

Timeframe: Up to approximately 2.2 years

Interventions:
Drug: Belantamab mafodotin
Drug: Bortezomib
Drug: Dexamethasone
Drug: Pomalidomide
Enrollment:
15
Observational study model:
Not applicable
Primary completion date:
2023-06-04
Time perspective:
Not applicable
Clinical publications:
Sunami K, Iida S, Tsukada N, Fujii T, Kato H, Fukushima R, Wakabayashi S, Nakano H, Roy-Ghanta S, Kremer BE. DREAMM-11, Part 2: Japanese phase I trial of belantamab mafodotin combination therapies in relapsed/refractory multiple myeloma. Int J Hematol. 2024 Dec 24. PMID: 39718747 DOI: 10.1007/s12185-024-03889-8
Medical condition
Multiple Myeloma
Product
Not applicable
Collaborators
Not applicable
Study date(s)
March 2019 to September 2024
Type
Interventional
Phase
1

Participation criteria

Sex
Female & Male
Age
20+ years
Accepts healthy volunteers
No
  • Inclusion Criteria
  • Provide signed written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
Inclusion and exclusion criteria
Inclusion 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).
  • ECOG performance status of 0 to 2.
  • Histologically or cytologically confirmed diagnosis of multiple myeloma as defined according to IMWG 2014, criteria in a participant who fulfills all of the following: has undergone stem cell transplant, or is considered transplant ineligible, Part 1: has received at least 2 prior lines of anti-myeloma drugs containing at least 1 proteasome inhibitor and at least 1 immunomodulator, Part 2: has received at least 1 prior line of anti-myeloma drugs; 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 mg/24 hours; Serum free light chain (FLC) assay: Involved FLC level >=10 mg/dL (>=100 mg/L) and an abnormal serum FLC ratio (<0.26 or >1.65).
  • Participants 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 participants: Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. A female participant 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 For Part 1 and Part 2 Arm A: Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of <1 percent per year), preferably with low user dependency, during the treatment period and for 4 months after the last dose of GSK2857916, and 7 months from the last dose of bortezomib (only Part 2 Arm A), 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 and agree to use effective contraception during the study and for 4 months after the last dose of GSK2857916, and 7 months from the last dose of bortezomib (only Part 2 Arm A); For Part 2 Arm B: Due to pomalidomide being a thalidomide analogue with risk for embryo-fetal toxicity and prescribed under a restricted distribution program, WOCBP participants will be eligible if they commit either to abstain continuously from heterosexual sexual intercourse or to use 2 methods of reliable birth control, beginning 4 weeks prior to initiating treatment with pomalidomide, during therapy, during dose interruptions and continuing for 4 weeks following discontinuation of pomalidomide treatment. Thereafter, WOCBP participants must use a contraceptive method that is highly effective (with a failure rate of <1 percent per year) for a further 3 months, and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period. Two negative pregnancy tests must be obtained prior to initiating pomalidomide therapy. The first test should be performed within 10 to 14 days and the second test within 24 hours prior to prescribing pomalidomide therapy. 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 participants: Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Male participants are eligible to participate if they agree to the following from the time of first dose of study treatment until 6 months after the last dose of GSK2857916, 4 months after the last dose of bortezomib (only Part 2 Arm A), and 4 weeks after the last dose of pomalidomide (only Part 2 Arm B) to allow for clearance of any altered sperm: 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 even if they have undergone a successful vasectomy and female partner to use an additional highly effective contraceptive method with a failure rate of <1 percent per year as when having sexual intercourse with a woman of childbearing potential (including pregnant females).
  • 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. Participants with Grade 2 peripheral neuropathy can be enrolled into Part 1 and Part 2 Arm B but not into Part 2 Arm A.
  • 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 participant's safety). Participants with isolated proteinuria resulting from multiple myeloma 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 participant'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 participant 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 study treatment on the currently targeted malignancy (multiple myeloma).
  • Evidence of cardiovascular risk including any of the following: a. Corrected QT interval Fridericia (QTcF) interval >=470 milliseconds (msecs) (the QT interval values must be corrected for heart rate by Fridericia’s formula [QTcF]) b. Evidence of current clinically significant uncontrolled arrhythmias, including clinically significant ECG abnormalities such as 2nd degree (Type II) or 3rd degree atrioventricular (AV) block. c. History of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting or bypass grafting within 6 months of Screening. d. Class III or IV heart failure as defined by the New York Heart Association functional classification system e. 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. Participants 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 participants 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 participant otherwise meets entry criteria.
  • Previously diagnosed with interstitial lung disease or current complication of interstitial lung disease. Additional Exclusion Criteria for Part 2 Arm A
  • Intolerant to bortezomib or refractory to bortezomib.
  • Ongoing Grade 2 or higher peripheral neuropathy or neuropathic pain.
  • Intolerance or contraindications to herpes zoster prophylaxis Additional Exclusion Criteria for Part 2 Arm B
  • Prior pomalidomide use.
  • Intolerance or contraindications to antithrombotic prophylaxis.
  • Active or history of venous thromboembolism within 3 months prior to first dose of study treatment.

Trial location(s)

Location
Status
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Location
GSK Investigational Site
Aichi, Japan, 467-8602
Status
Study Complete
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Location
GSK Investigational Site
Tokyo, Japan, 135-8550
Status
Study Complete
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Location
GSK Investigational Site
Okayama, Japan, 701-1192
Status
Study Complete
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Location
GSK Investigational Site
Shibuya-Ku, Tokyo, Japan, 150-8935
Status
Study Complete
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Study documents

Study report synopsis
Available language(s): English
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Protocol
Available language(s): English
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Statistical analysis plan
Available language(s): English
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If you wish to request for full study report, please contact - [email protected]

Results overview

Results posted on ClinicalTrials.gov

Recruitment status
Completed
Actual primary completion date
2023-06-04
Actual study completion date
2024-05-09

Plain language summaries

Summary of results in plain language
Available language(s): English, Japanese
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To view plain language summaries on trialsummaries.com click here.

Additional information about the trial

Additional information
Not applicable
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