NCT03828292 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE1
Status at capture: COMPLETED
Registry last update: 2025-08-19

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Part 1: Number of Participants With Dose Limiting Toxicities (DLTs)

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outcome · POSTED

Part 2: Arm A: Number of Participants With DLTs

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outcome · POSTED

Part 2: Arm B: Number of Participants With DLTs

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outcome · POSTED

Part 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

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outcome · POSTED

Part 2: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

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outcome · POSTED

Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters

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Part 1: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters

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Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters

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Part 2: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters

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Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters

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Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters

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Part 2: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters

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Part 2: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters

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Part 1: Number of Participants With Worst-case Change in Post Baseline Values Relative to Baseline Urinalysis Results: Occult Blood and Protein

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Part 2: Number of Participants With Worst-case Change in Post Baseline Values Relative to Baseline Urinalysis Results: Occult Blood and Protein

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Part 1: Change From Baseline (CFB) in Urine Potential of Hydrogen (pH)

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Part 2: Change From Baseline in Urine Potential of Hydrogen (pH)

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Part 1: Change From Baseline in Urine Specific Gravity by Dipstick

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Part 2: Change From Baseline in Urine Specific Gravity by Dipstick

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Part 1: Number of Participants With Worst-case Grade Change Post-baseline in Vital Sign Parameters: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)

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Part 2: Number of Participants With Worst-case Grade Change Post-baseline in Vital Sign Parameters: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)

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Part 1: Number of Participants With Worst-case Change Post-baseline in Vital Sign Parameters: Temperature

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Part 2: Number of Participants With Worst-case Change Post-baseline in Vital Sign Parameters: Temperature

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Part 1: Number of Participants With Worst-case Change Post-baseline in Vital Sign Parameters: Heart Rate

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Part 2: Number of Participants With Worst-case Change Post-baseline in Vital Sign Parameters: Heart Rate

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Part 1: Number of Participants With Worst-Case Amount of Increase From Baseline Value in Corrected QT Interval Using Fredericia's Formula (QTcF)

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Part 2: Number of Participants With Worst-Case Amount of Increase From Baseline Value in QTcF

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Part 1: Number of Participants With Worst-case Change Post-baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status

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outcome · POSTED

Part 1: Area Under the Concentration-time Curve During the Dosing Interval (AUC (0-tau)) Following Single Dose Administration of Belantamab Mafodotin (Antibody-drug Conjugate (ADC))

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Part 1: AUC Extrapolated to Infinity (AUC (0-inf)) Following Single Dose Administration of Belantamab Mafodotin (ADC)

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Part 1: AUC From Time Zero to the Time of the Last Quantifiable Concentration (AUC (0 - Tlast)) Following Single Dose Administration of Belantamab Mafodotin (ADC)

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outcome · POSTED

Part 1: Systemic Clearance (CL) Following Single Dose Administration of Belantamab Mafodotin (ADC)

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Part 1: Apparent Terminal Half-life (t1/2) Following Single Dose Administration of Belantamab Mafodotin (ADC)

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Part 1: Terminal Phase Rate Constant (Lambda_z) Following Single Dose Administration of Belantamab Mafodotin (ADC)

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Part 1: Volume of Distribution at Steady State (Vss) Following Single Dose Administration of Belantamab Mafodotin (ADC)

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Part 1: Time of Last Observed Quantifiable Concentration (Tlast) Following Single Dose Administration of Belantamab Mafodotin (ADC)

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Part 1: Time to Maximum Plasma Concentration (Tmax) Following Single Dose Administration of Belantamab Mafodotin (ADC)

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outcome · POSTED

Part 1: Concentration at the End of Infusion (C-EOI) Following Repeat Dose Administration of Belantamab Mafodotin (ADC)

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Part 1: Maximum Observed Concentration (Cmax) Following Repeat Dose Administration of Belantamab Mafodotin (ADC)

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Part 1: Trough Plasma Concentration (Ctrough) Following Repeat Dose Administration of Belantamab Mafodotin (ADC)

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outcome · POSTED

Part 1: AUC (0-tau) Following Single Dose Administration of Belantamab Mafodotin (Total Antibody)

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outcome · POSTED

Part 1: AUC (0-inf) Following Single Dose Administration of Belantamab Mafodotin (Total Antibody)

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outcome · POSTED

Part 1: AUC (0 - Tlast) Following Single Dose Administration of Belantamab Mafodotin (Total Antibody)

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outcome · POSTED

Part 1: Systemic Clearance (CL) Following Single Dose Administration of Belantamab Mafodotin (Total Antibody)

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outcome · POSTED

Part 1: t1/2 Following Single Dose Administration of Belantamab Mafodotin (Total Antibody)

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outcome · POSTED

Part 1: Lambda_z Following Single Dose Administration of Belantamab Mafodotin (Total Antibody)

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outcome · POSTED

Part 1: Vss Following Single Dose Administration of Belantamab Mafodotin (Total Antibody)

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outcome · POSTED

Part 1: Tlast Following Single Dose Administration of Belantamab Mafodotin (Total Antibody)

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outcome · POSTED

Part 1: Tmax Following Single Dose Administration of Belantamab Mafodotin (Total Antibody)

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outcome · POSTED

Part 1: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody)

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Part 1: Cmax Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody)

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Part 1: Ctrough Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody)

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Part 1: AUC (0 - Tlast) Following Single Dose Administration of Belantamab Mafodotin Cysteine Maleimidocaproyl Monomethyl Auristatin F (Cys-mcMMAF)

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outcome · POSTED

Part 1: Cmax Following Single Dose Administration of Belantamab Mafodotin (Cys-mcMMAF)

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Part 1: Tlast Following Single Dose Administration of Belantamab Mafodotin (Cys-mcMMAF)

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outcome · POSTED

Part 1: Tmax Following Single Dose Administration of Belantamab Mafodotin (Cys-mcMMAF)

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outcome · POSTED

Part 1: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (Cys-mcMMAF)

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Part 1: Ctrough Following Repeat Dose Administration of Belantamab Mafodotin (Cys-mcMMAF)

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Part 1: Observed Accumulation Ratio of C-EOI (R(C-EOI)) Following Repeat Dose Administration of Belantamab Mafodotin (ADC)

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Part 1: Observed Accumulation Ratio of Ctrough (R(Ctrough)) Following Repeat Dose Administration of Belantamab Mafodotin (ADC)

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Part 1: Observed Accumulation Ratio of C-EOI (R(C-EOI)) Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody)

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outcome · POSTED

Part 1: Observed Accumulation Ratio of Ctrough (R(Ctrough)) Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody)

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outcome · POSTED

Part 1: Observed Accumulation Ratio of C-EOI (R(C-EOI)) Following Repeat Dose Administration of Belantamab Mafodotin (Cys-mcMMAF)

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outcome · POSTED

Part 2: AUC (0-tau) Following Single Dose Administration of Belantamab Mafodotin (ADC)

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Part 2: AUC (0-inf) Following Single Dose Administration of Belantamab Mafodotin (ADC)

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outcome · POSTED

Part 2: AUC (0 - Tlast) Following Single Dose Administration of Belantamab Mafodotin (ADC)

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outcome · POSTED

Part 2: CL Following Single Dose Administration of Belantamab Mafodotin (ADC)

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outcome · POSTED

Part 2: Cmax Following Repeat Dose Administration of Belantamab Mafodotin (ADC)

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outcome · POSTED

Part 2: Lambda_z Following Single Dose Administration of Belantamab Mafodotin (ADC)

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outcome · POSTED

Part 2: Vss Following Single Dose Administration of Belantamab Mafodotin (ADC)

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outcome · POSTED

Part 2: t1/2 Following Single Dose Administration of Belantamab Mafodotin (ADC)

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Part 2: Tlast Following Single Dose Administration of Belantamab Mafodotin (ADC)

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outcome · POSTED

Part 2: Tmax Following Single Dose Administration of Belantamab Mafodotin (ADC)

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outcome · POSTED

Part 2 Arm A: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (ADC)

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outcome · POSTED

Part 2 Arm A: Ctrough Following Repeat Dose Administration of Belantamab Mafodotin (ADC)

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outcome · POSTED

Part 2 Arm B: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (ADC)

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outcome · POSTED

Part 2 Arm B: Ctrough Following Repeat Dose Administration of Belantamab Mafodotin (ADC)

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outcome · POSTED

Part 2: AUC (0-tau) Following Single Dose Administration of Belantamab Mafodotin (Total Antibody)

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outcome · POSTED

Part 2: AUC (0-inf) Following Single Dose Administration of Belantamab Mafodotin (Total Antibody)

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outcome · POSTED

Part 2: AUC (0 - Tlast) Following Single Dose Administration of Belantamab Mafodotin (Total Antibody)

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outcome · POSTED

Part 2: Cmax Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody)

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outcome · POSTED

Part 2: Lambda_z Following Single Dose Administration of Belantamab Mafodotin (Total Antibody)

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outcome · POSTED

Part 2: Vss Following Single Dose Administration of Belantamab Mafodotin (Total Antibody)

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outcome · POSTED

Part 2: t1/2 Following Single Dose Administration of Belantamab Mafodotin (Total Antibody)

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outcome · POSTED

Part 2: Tlast Following Single Dose Administration of Belantamab Mafodotin (Total Antibody)

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outcome · POSTED

Part 2: Tmax Following Single Dose Administration of Belantamab Mafodotin (Total Antibody)

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outcome · POSTED

Part 2: Arm A: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody)

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outcome · POSTED

Part 2: Arm A: Ctrough Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody)

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outcome · POSTED

Part 2: Arm B: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody)

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outcome · POSTED

Part 2: Arm B: Ctrough Following Repeat Dose Administration of Belantamab Mafodotin (Total Antibody)

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outcome · POSTED

Part 2: AUC (0 - Tlast) Following Single Dose Administration of Belantamab Mafodotin (Cys-mcMMAF)

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outcome · POSTED

Part 2: Cmax Following Repeat Dose Administration of Belantamab Mafodotin (Cys-mcMMAF)

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outcome · POSTED

Part 2: Tlast Following Single Dose Administration of Belantamab Mafodotin (Cys-mcMMAF)

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outcome · POSTED

Part 2: Tmax Following Single Dose Administration of Belantamab Mafodotin (Cys-mcMMAF)

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outcome · POSTED

Part 2 Arm A: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (Cys-mcMMAF)

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outcome · POSTED

Part 2: Arm A: Ctrough Following Repeat Dose Administration of Belantamab Mafodotin (Cys-mcMMAF)

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outcome · POSTED

Part 2: Arm B: C-EOI Following Repeat Dose Administration of Belantamab Mafodotin (Cys-mcMMAF)

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outcome · POSTED

Part 2: Arm B: Ctrough Following Repeat Dose Administration of Belantamab Mafodotin (Cys-mcMMAF)

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outcome · POSTED

Part 1: Number of Participants With Anti-drug Antibodies (ADAs) Against Belantamab Mafodotin

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outcome · POSTED

Part 2: Number of Participants With Anti-drug Antibodies (ADAs) Against Belantamab Mafodotin

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outcome · POSTED

Part 1: Titers of ADAs Against Belantamab Mafodotin

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Part 2: Titers of ADAs Against Belantamab Mafodotin

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outcome · POSTED

Part 1 - Percentage of Participants With Overall Response Rate (ORR)

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Part 2 - Percentage of Participants With ORR

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outcome · POSTED

Part 1: Clinical Benefit Rate (CBR)

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Part 2: Clinical Benefit Rate (CBR)

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Part 2: Number of Participants With Clinically Significant Abnormalities in ECOG Performance Status

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility 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: 1. Corrected QT interval Fridericia (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. 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.
healthy Volunteers: false
minimum Age: 20 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

intervention Names
Drug: Belantamab mafodotin
label
Part 1: Belantamab mafodotin Monotherapy
type
EXPERIMENTAL
intervention Names
Drug: Belantamab mafodotin
Drug: Bortezomib
Drug: Dexamethasone
label
Part 2: Arm A: Belantamab mafodotin+Bortezomib/Dexamethasone
type
EXPERIMENTAL
intervention Names
Drug: Belantamab mafodotin
Drug: Dexamethasone
Drug: Pomalidomide
label
Part 2: Arm B: Belantamab mafodotin+Pomalidomide/Dexamethasone
type
EXPERIMENTAL

interventions

arm Group Labels
Part 1: Belantamab mafodotin Monotherapy
Part 2: Arm A: Belantamab mafodotin+Bortezomib/Dexamethasone
Part 2: Arm B: Belantamab mafodotin+Pomalidomide/Dexamethasone
description
Belantamab mafodotin will be administered as an intravenous infusion.
name
Belantamab mafodotin
type
DRUG
arm Group Labels
Part 2: Arm A: Belantamab mafodotin+Bortezomib/Dexamethasone
description
Bortezomib solution for injection will be administered subcutaneously.
name
Bortezomib
type
DRUG
arm Group Labels
Part 2: Arm A: Belantamab mafodotin+Bortezomib/Dexamethasone
Part 2: Arm B: Belantamab mafodotin+Pomalidomide/Dexamethasone
description
Dexamethasone tablets will be administered orally.
name
Dexamethasone
type
DRUG
arm Group Labels
Part 2: Arm B: Belantamab mafodotin+Pomalidomide/Dexamethasone
description
Pomalidomide capsules will be administered orally.
name
Pomalidomide
type
DRUG

Study design

allocation

NON_RANDOMIZED

intervention Model

SEQUENTIAL

intervention Model Description

Participants will receive GSK2857916 monotherapy during Part 1 (Dose escalation) of the study on a once every 21 days schedule. During Part 2, participants will receive GSK2857916 given in combination with Bortezomib/Dexamethasone on a once every 21 days schedule (Arm A) or with Pomalidomide/Dexamethasone on a once every 28 days schedule (Arm B).

masking Info

masking: NONE
masking Description: This will be an open-label study.

primary Purpose

TREATMENT

Enrollment

count: 15
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
DLT is an Adverse Event (AE) that is considered by the investigator to be clinically relevant and attributed to the study therapy during the 21-day DLT period and meets at least one of the DLT criteria: Grade 3 or greater febrile neutropenia lasting \>48 hours (h) despite adequate treatment, Grade 4 thrombocytopenia \<25,000/mm\^3accompanied by clinically significant bleeding, any Grade 3 or greater non-hematologic toxicity, any Grade 3 or greater non-hematologic laboratory value if: laboratory abnormality persists for \>48 h despite supportive treatment for abnormality leads to hospitalization, Grade 4 Corneal toxicity, and liver toxicity meeting pre-specified GlaxoSmithKline liver stopping criteria. DLTs were assessed by National Cancer Institute- Common Toxicity Criteria for Adverse Events (NCI-CTCAE), version 4.03.
measure
Part 1: Number of Participants With Dose Limiting Toxicities (DLTs)
time Frame
Up to Day 21
description
DLT is an AE that is considered by the investigator to be clinically relevant and attributed to the study therapy during the 21-day DLT period and meets at least one of the DLT criteria: Grade 3 or greater febrile neutropenia lasting \>48 hours (h) despite adequate treatment, Grade 4 thrombocytopenia \<25,000/mm\^3 accompanied by clinically significant bleeding, any Grade 3 or greater non-hematologic toxicity, any Grade 3 or greater non-hematologic laboratory value if: laboratory abnormality persists for \>48 h despite supportive treatment or abnormality leads to hospitalization, Grade 4 Corneal toxicity, and liver toxicity meeting pre-specified GlaxoSmithKline liver stopping criteria. DLTs were assessed by NCI-CTCAE, version 4.03.
measure
Part 2: Arm A: Number of Participants With DLTs
time Frame
Up to Day 21
description
DLT is an AE that is considered by the investigator to be clinically relevant and attributed to the study therapy during the 21-day DLT period and meets at least one of the DLT criteria: Grade 3 or greater febrile neutropenia lasting \>48 hours (h) despite adequate treatment, Grade 4 thrombocytopenia \<25,000/mm\^3 accompanied by clinically significant bleeding, any Grade 3 or greater non-hematologic toxicity, any Grade 3 or greater non-hematologic laboratory value if: laboratory abnormality persists for \>48 h despite supportive treatment or abnormality leads to hospitalization, Grade 4 Corneal toxicity, and liver toxicity meeting pre-specified GlaxoSmithKline liver stopping criteria. DLTs were assessed by NCI-CTCAE, version 4.03.
measure
Part 2: Arm B: Number of Participants With DLTs
time Frame
Up to Day 28
description
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death; was life threatening; required hospitalization or prolongation of existing hospitalization; resulted in disability/incapacity; was a congenital anomaly/birth defect. SAEs are subset of AEs.
measure
Part 1: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
time Frame
Up to approximately 141 weeks
description
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. 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 or Is a congenital anomaly/birth defect other situations which involve medical or scientific judgment or is associated with liver injury and impaired liver function. SAEs are subset of AEs.
measure
Part 2: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
time Frame
Up to approximately 212 weeks
description
Blood samples were collected for clinical chemistry parameters analysis: Creatine Kinase (CK), Creatinine, Gamma Glutamyl Transferase (GGT), Magnesium, Phosphate, Potassium, Sodium, Calcium, Glucose, Urate, Alanine Aminotransferase (ALT), Albumin, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Bilirubin were graded according to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version (v) 4.03. Grade (G)1: mild; G2: moderate; G3: severe or medically significant; G4: life-threatening consequences. Higher grade indicates greater severity and increase in grade was defined relative to Baseline grade. Any worst-case post baseline increases in grade along with any increase to a maximum G3 and a maximum G4 are presented. Baseline was defined as the latest pre-dose assessment within 21 days prior to first dose with a non-missing value, including those from unscheduled visits.
measure
Part 1: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
time Frame
Baseline (Day 1) and up to approximately 141 weeks
description
Blood samples were collected for analysis of clinical chemistry parameters: C Reactive Protein, Chloride, Direct Bilirubin (DB), Lactate Dehydrogenase, Protein and Urea. The summaries of worst-case change from baseline with respect to normal range was analyzed for only those laboratory tests that were not gradable by CTCAE v4.03. The number of participants with decreases to low from baseline, changes to normal or no changes from baseline, and increases to high values have been presented. Baseline was defined as the latest pre-dose assessment within 21 days prior to first dose with a non-missing value, including those from unscheduled visits.
measure
Part 1: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters
time Frame
Baseline (Day 1) and up to approximately 141 weeks
description
Blood samples were collected for clinical chemistry parameters analysis: Creatine Kinase (CK), Creatinine, Gamma Glutamyl Transferase (GGT), Magnesium, Phosphate, Potassium, Sodium, Calcium, Glucose, Urate, Alanine Aminotransferase (ALT), Albumin, Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Bilirubin were graded according to NCI-CTCAE v 4.03. G1: mild; G2: moderate; G3: severe or medically significant; G4: life-threatening consequences. Higher grade indicates greater severity and increase in grade was defined relative to Baseline grade. Any worst-case post baseline increases in grade along with any increase to a maximum G3 and a maximum G4 are presented. Baseline was defined as the latest pre-dose assessment within 21 days prior to first dose with a non-missing value, including those from unscheduled visits.
measure
Part 2: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry Parameters
time Frame
Baseline (Day 1) and up to approximately 212 weeks
description
Blood samples were collected for analysis of clinical chemistry parameters: C Reactive Protein, Chloride, Direct Bilirubin (DB), Lactate Dehydrogenase, Protein and Urea. The summaries of worst-case change from baseline with respect to normal range was analyzed for only those laboratory tests that were not gradable by CTCAE v4.03. The number of participants with decreases to low from baseline, changes to normal or no changes from baseline, and increases to high values have been presented. Baseline was defined as the latest pre-dose assessment within 21 days prior to first dose with a non-missing value, including those from unscheduled visits.
measure
Part 2: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters
time Frame
Baseline (Day 1) and up to approximately 212 weeks
description
Blood samples were collected for analysis of hematology parameters: Hemoglobin, Leukocytes, Lymphocytes, Neutrophils and Platelets were graded according to CTCAE v4.03. G1: mild; G2: moderate; G3: severe or medically significant; G4: life-threatening consequences. Higher grade indicates greater severity and increase in grade was defined relative to Baseline grade. Any worst-case post baseline increases in grade along with any increase to a maximum G3 and a maximum G4 are presented. Baseline was defined as the latest pre-dose assessment within 21 days prior to first dose with a non-missing value, including those from unscheduled visits.
measure
Part 1: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters
time Frame
Baseline (Day 1) and up to approximately 141 weeks
description
Blood samples were collected for the analysis of following hematology parameters: Basophils, Eosinophils, Mean Corpuscular Hemoglobin Concentration (MCHC), Mean Corpuscular Hemoglobin (MCH), Mean Corpuscular Volume (MCV), erythrocytes, Hematocrit, monocytes and reticulocytes. The summaries of worst-case change from baseline with respect to normal range was analyzed for only those laboratory tests that were not gradable by CTCAE version 4.03. The number of participants with decreases to low from baseline, changes to normal or no changes from baseline, and increases to high values have been presented. Baseline was defined as the latest pre-dose assessment within 21 days prior to first dose with a non-missing value, including those from unscheduled visits.
measure
Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
time Frame
Baseline (Day 1) and up to approximately 141 weeks
description
Blood samples were collected for analysis of hematology parameters: Hemoglobin, Leukocytes, Lymphocytes, Neutrophils and Platelets were graded according to CTCAE v4.03. G1: mild; G2: moderate; G3: severe or medically significant; G4: life-threatening consequences. Higher grade indicates greater severity and increase in grade was defined relative to Baseline grade. Any worst-case post baseline increases in grade along with any increase to a maximum G3 and a maximum G4 are presented. Baseline was defined as the latest pre-dose assessment within 21 days prior to first dose with a non-missing value, including those from unscheduled visits.
measure
Part 2: Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters
time Frame
Baseline (Day 1) and up to approximately 212 weeks

secondary Outcomes

description
Blood samples were collected for pharmacokinetic (PK) analysis. PK parameter was determined using standard non-compartmental methods.
measure
Part 1: Area Under the Concentration-time Curve During the Dosing Interval (AUC (0-tau)) Following Single Dose Administration of Belantamab Mafodotin (Antibody-drug Conjugate (ADC))
time Frame
Pre-Dose; End of Infusion (EOI); 1 hour (h), 3 h, 8 h and 24 h post-EOI, Day 8, Day 15 in Cycle 1; Pre-Dose on Cycle 2 Day 1
description
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
measure
Part 1: AUC Extrapolated to Infinity (AUC (0-inf)) Following Single Dose Administration of Belantamab Mafodotin (ADC)
time Frame
Pre-Dose; EOI; 1 h, 3 h, 8 h and 24 h post-EOI, Day 8, Day 15 in Cycle 1; Pre-Dose on Cycle 2 Day 1
description
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
measure
Part 1: AUC From Time Zero to the Time of the Last Quantifiable Concentration (AUC (0 - Tlast)) Following Single Dose Administration of Belantamab Mafodotin (ADC)
time Frame
Pre-Dose; EOI; 1 h, 3 h, 8 h and 24 h post-EOI, Day 8, Day 15 in Cycle 1; Pre-Dose on Cycle 2 Day 1
description
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
measure
Part 1: Systemic Clearance (CL) Following Single Dose Administration of Belantamab Mafodotin (ADC)
time Frame
Pre-Dose; EOI; 1 h, 3 h, 8 h and 24 h post-EOI, Day 8, Day 15 in Cycle 1; Pre-Dose on Cycle 2 Day 1
description
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
measure
Part 1: Apparent Terminal Half-life (t1/2) Following Single Dose Administration of Belantamab Mafodotin (ADC)
time Frame
Pre-Dose; EOI; 1 h, 3 h, 8 h and 24 h post-EOI, Day 8, Day 15 in Cycle 1; Pre-Dose on Cycle 2 Day 1
description
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
measure
Part 1: Terminal Phase Rate Constant (Lambda_z) Following Single Dose Administration of Belantamab Mafodotin (ADC)
time Frame
Pre-Dose; EOI; 1 h, 3 h, 8 h and 24 h post-EOI, Day 8, Day 15 in Cycle 1; Pre-Dose on Cycle 2 Day 1
description
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
measure
Part 1: Volume of Distribution at Steady State (Vss) Following Single Dose Administration of Belantamab Mafodotin (ADC)
time Frame
Pre-Dose; EOI; 1 h, 3 h, 8 h and 24 h post-EOI, Day 8, Day 15 in Cycle 1; Pre-Dose on Cycle 2 Day 1
description
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
measure
Part 1: Time of Last Observed Quantifiable Concentration (Tlast) Following Single Dose Administration of Belantamab Mafodotin (ADC)
time Frame
Pre-Dose; EOI; 1 h, 3 h, 8 h and 24 h post-EOI, Day 8, Day 15 in Cycle 1; Pre-Dose on Cycle 2 Day 1
description
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
measure
Part 1: Time to Maximum Plasma Concentration (Tmax) Following Single Dose Administration of Belantamab Mafodotin (ADC)
time Frame
Pre-Dose; EOI; 1 h, 3 h, 8 h and 24 h post-EOI, Day 8, Day 15 in Cycle 1; Pre-Dose on Cycle 2 Day 1
description
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
measure
Part 1: Concentration at the End of Infusion (C-EOI) Following Repeat Dose Administration of Belantamab Mafodotin (ADC)
time Frame
Cycle 1, Cycle 2, Cycle 3, Cycle 6, Cycle 9 and Cycle 12
description
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
measure
Part 1: Maximum Observed Concentration (Cmax) Following Repeat Dose Administration of Belantamab Mafodotin (ADC)
time Frame
Cycle 1, Cycle 2, Cycle 3, Cycle 6, Cycle 9 and Cycle 12
description
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
measure
Part 1: Trough Plasma Concentration (Ctrough) Following Repeat Dose Administration of Belantamab Mafodotin (ADC)
time Frame
Cycle 1, Cycle 2, Cycle 5, Cycle 8 and Cycle 11

Full study description

brief Summary: 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.

Source references

references

citation
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. 2025 Feb;121(2):174-186. doi: 10.1007/s12185-024-03889-8. Epub 2024 Dec 24.
pmid
39718747
type
BACKGROUND

Source notices and limitations

Discovery and provenance

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Preserved source evidence · Not medical advice