NCT07217184 · REGISTRY CONDITION SEARCH

Sub-study of Belantamab Mafodotin (GSK2857916) in Combination With Isatuximab in Participants With RRMM

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

Phase: PHASE1, PHASE2
Status at capture: ACTIVE NOT RECRUITING
Registry last update: 2026-06-25

The primary purpose is to determine the safety and tolerability of belantamab mafodotin in combination with isatuximab, and to establish the recommended Phase 2 dose (RP2D) for the combination treatment to explore in the cohort expansion (CE) phase in participants with RRMM. This study is a sub study of the Master protocol (NCT04126200).

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

Dose Expansion (DE) Phase: Number of Participants With Dose Limiting Toxicities (DLT)

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outcome · POSTED

DE Phase: Number of Participants With Adverse Events (AEs)

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outcome · POSTED

DE Phase: Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post - Baseline Relative to Baseline

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outcome · POSTED

DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline

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outcome · POSTED

Cohort Expansion (CE) Phase: Overall Response Rate (ORR)

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outcome · POSTED

DE Phase: Overall Response Rate (ORR)

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outcome · POSTED

CE Phase: Clinical Benefit Rate (CBR)

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outcome · POSTED

DE Phase: Percentage of Participants Achieving Stringent Complete Response (SCR), Complete Response (CR), Very Good Partial Response (VGPR) and Partial Response (PR)

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outcome · POSTED

CE Phase: Percentage of Participants Achieving SCR, CR, VGPR and PR

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outcome · POSTED

DE Phase: Plasma Concentrations of Belantamab Mafodotin Antibody-Drug Conjugate (ADC)

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outcome · POSTED

CE Phase: Plasma Concentration of Belantamab Mafodotin Antibody-Drug Conjugate (ADC)

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outcome · POSTED

DE Phase: Plasma Concentration of Belantamab Mafodotin Total Antibody

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outcome · POSTED

CE Phase: Plasma Concentration of Belantamab Mafodotin Plasma Total Antibody

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outcome · POSTED

DE Phase: Plasma Concentration of Belantamab Mafodotin Cys- Monomethyl Auristatin-F (Cys-mcMMAF)

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outcome · POSTED

CE Phase: Plasma Concentration of Belantamab Mafodotin Cys- Monomethyl Auristatin-F (Cys-mcMMAF)

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outcome · POSTED

DE Phase: Isatuximab Concentration When Administered in Combination With Belantamab Mafodotin

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outcome · POSTED

CE Phase: Isatuximab Concentration When Administered in Combination With Belantamab Mafodotin

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outcome · POSTED

DE Phase: Number of Participants With Post-baseline Positive Anti-drug Antibodies (ADAs) Against Belantamab Mafodotin

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outcome · POSTED

CE Phase: Number of Participants With Post-baseline Positive ADAs Against Belantamab Mafodotin

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outcome · POSTED

DE Phase: Titer of ADAs Against Belantamab Mafodotin

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outcome · POSTED

CE Phase: Titer of ADAs Against Belantamab Mafodotin

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outcome · POSTED

DE Phase: Number of Participants With Adverse Events of Special Interest (AESI)

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outcome · POSTED

CE Phase: Number of Participants With AESI

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outcome · POSTED

DE Phase: Number of Participants With Any Corneal Events by Maximum Grade as Per CTCAE Grade

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outcome · POSTED

CE Phase: Number of Participants With Any Corneal Events by Maximum Grade as Per CTCAE Grade

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outcome · POSTED

CE Phase: Progression-free Survival (PFS)

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outcome · POSTED

CE Phase: Duration of Response (DoR)

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outcome · POSTED

CE Phase: Time to Response (TTR)

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outcome · POSTED

CE Phase: Overall Survival (OS)

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outcome · POSTED

CE Phase: Number of Participants With AEs and SAEs

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outcome · POSTED

CE Phase: Number of Participants With AEs Leading to Discontinuation

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outcome · POSTED

CE Phase: Number of Participants With Dose Reduction or Delay

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outcome · POSTED

CE Phase: Number of Participants With Clinically Significant Changes in Hematology Lab Parameters

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outcome · POSTED

CE Phase: Number of Participants With Clinically Significant Changes in Clinical Chemistry Lab Parameters

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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: * Participant must be 18 years of age inclusive or older, at the time of signing the informed consent. * Participants must have histologically or cytologically confirmed diagnosis of Multiple Myeloma (MM), as defined by the IMWG. * Participants having at least 3 prior lines of prior anti-myeloma treatments including an immunomodulating agent (IMID) a proteasome inhibitor (PI) and an anti-CD38 monoclonal antibody. * Participants with a history of autologous stem cell transplant are eligible for study participation when, transplant was \>100 days prior to study enrolment and with no active infection(s). * Participants with Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, unless ECOG less than equal to (\<=)2 is due solely to skeletal complications and/or skeletal pain due to MM. * Participants with measurable disease defined as at least one of the following: Serum M-protein greater than equal to (\>=)0.5 gram per deciliter (\>=5 gram per liter) or Urine M-protein \>=200 milligrams (mg) per 24 hours or Serum free light chain (FLC) assay: Involved FLC level \>=10 mg per deciliter (\>=100 mg per Liter) and an abnormal serum FLC ratio (\<0.26 or \>1.65). * Participants who have tested positive for Hepatitis B core antibody (HBcAb) can be enrolled if the following criteria are met: Serology result HBcAb+, Hepatitis B surface antigen (HBsAg)-; HBV deoxyribonucleic acid (DNA) undetectable during screening. * Participants who are currently receiving physiological doses oral steroids (\<10 mg/day), inhaled steroids or ophthalmological steroids. Exclusion Criteria: * Participants with current corneal epithelial disease except mild punctate keratopathy. * Participants with evidence of cardiovascular risk. * Participants with known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to belantamab mafodotin or any of the components of the study treatment. History of severe hypersensitivity to other mAb. * Participants with active infection requiring antibiotic, antiviral, or antifungal treatment. * Participants with other monoclonal antibodies within 30 days or systemic anti-myeloma therapy within \<14 days. * Participants with prior radiotherapy within 2 weeks of start of study therapy. * Participants with prior allogeneic transplant are prohibited. * Participants who have received prior Chimeric Antigen T cell therapy (CAR-T) therapy with lymphodepletion with chemotherapy within 3 months of screening. * Participants with any major surgery (other than bone-stabilizing surgery) within the last 30 days. * Participants with prior treatment with an investigational agent within 14 days or 5 half-lives of receiving the first dose of study drugs, whichever is shorter. * Participants with \>=grade 3 toxicity considered related to prior check-point inhibitors and that led to treatment discontinuation. * Participants who have received transfusion of blood products within 2 weeks before the first dose of study drug. * Participants must not receive live attenuated vaccines within 30 days prior to first dose of study treatment or whilst receiving belantamab mafodotin +- partner agent in any sub-study arm of the platform trial and for at least 70 days following last study treatment. * Participants with 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 MM. * Participants with known human immunodeficiency virus (HIV) infection, unless the participant can meet all criteria: a) established anti-retroviral therapy for at least 4 weeks and HIV viral load\<400 copies/milliliter (mL) b) cluster of differentiation 4 plus (CD4+) T-cell (CD4+) counts \>= 350 cells/microliter (µL) c) No history of Acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections within the last 12 months in which case the participant would be eligible for CE Phase only. For participants receiving nirogacestat, HIV drugs that are strong Cytochrome P450 3A4 (CYP3A4) inhibitors are prohibited. HIV drugs that are moderate CYP3A4 inhibitors, while permitted, should be co-administered with caution and must be accompanied by nirogacestat dose modifications. * Participants with Severe hypersensitivity to Isatuximab-irfc or to any of its excipients. * Participants with prior treatment with other anti-CD38 monoclonal antibody within 6 months of the first dose of study drug treatment. * Participants with known intolerance or hypersensitivity to infused proteins products, sucrose, histidine, and polysorbate 80.
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

intervention Names
Drug: Belantamab mafodotin
Drug: Isatuximab
label
Belantamab mafodotin + Isatuximab
type
EXPERIMENTAL

interventions

arm Group Labels
Belantamab mafodotin + Isatuximab
description
Belantamab mafodotin will be administered.
name
Belantamab mafodotin
other Names
GSK2857916
type
DRUG
arm Group Labels
Belantamab mafodotin + Isatuximab
description
Isatuximab will be administered.
name
Isatuximab
type
DRUG

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 30
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
Criteria for dose-limiting toxicity (DLT) included hematologic indicators such as Grade 3-5 febrile neutropenia and thrombocytopenia with bleeding. Non-hematologic criteria, excluding corneal toxicity, comprise Grade 3-5 toxicities, with exceptions for manageable nausea, vomiting, or diarrhea, controlled Grade 3 hypertension, and events linked to disease progression. Tumor lysis syndrome (TLS) of Grade 3 or 4, successfully managed within 7 days without end-organ damage, is considered. Corneal toxicity, assessed by the GSK corneal grading scale at Grade 4, is a DLT. Other organ-specific toxicities, notably liver toxicity meeting GSK stopping criteria, also qualify as DLT severity was graded using National Cancer Institute (NCI) - Common Terminology Criteria for Adverse Events (CTCAE) Version (v) 5.0.
measure
Dose Expansion (DE) Phase: Number of Participants With Dose Limiting Toxicities (DLT)
time Frame
Up to 28 days
description
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) coding system.
measure
DE Phase: Number of Participants With Adverse Events (AEs)
time Frame
Up to approximately 194 weeks
description
Blood samples were collected for the analysis of hematology parameters. The laboratory parameters were graded according to CTCAE v 5.0. Grade 1 (G1): mild; Grade 2 (G2): moderate; Grade 3 (G3): severe; Grade 4 (G4) life-threatening or disabling. Higher grade indicates greater severity and an increase in CTCAE grade was defined relative to the Baseline grade. Any worst-case post baseline increase to G1, G2, G3, and G4 are presented. Baseline value was defined as the most recent, non-missing value from a local laboratory prior to the first dose of study treatment. WBC: White blood cells.
measure
DE Phase: Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post - Baseline Relative to Baseline
time Frame
Baseline (Day 1) and up to approximately 194 weeks
description
Blood samples were collected for the analysis of chemistry parameters. The laboratory parameters were graded according to CTCAE version 5. G1: mild; G2: moderate; G3: severe. Higher grade indicates greater severity and an increase in CTCAE grade was defined relative to the Baseline grade. Any worst-case post baseline increase to G1, G2 and G3 are presented. Baseline value was defined as the most recent, non-missing value from a local laboratory prior to the first dose of study treatment. BLD : Blood lactate dehydrogenase, CPK: Creatine Kinase.
measure
DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline
time Frame
Baseline (Day 1) and up to approximately 194 weeks
description
Overall Response Rate (ORR) was defined as the percentage of participants with a confirmed Partial Response (PR) or better as the best overall response (i.e., PR, Very Good Partial Response \[VGPR\], Complete Response \[CR\], and stringent Complete Response \[sCR\]), as assessed by the investigator per international myeloma working group (IMWG) (2016). PR is defined as ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to \<200 mg/24 h. VGPR is defined as serum and urine M-component detectable by immunofixation but not on electrophoresis OR ≥ 90% reduction in serum M-component plus urine M-component \<100 mg/24 h. CR is defined as negative immunofixation of serum and urine AND disappearance of any soft tissue plasmacytomas AND \<5% plasmacytomas in the bone marrow. sCR is defined as CR as above PLUS normal serum free light-chain (FLC) assay ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence.
measure
Cohort Expansion (CE) Phase: Overall Response Rate (ORR)
time Frame
Up to approximately 194 weeks

secondary Outcomes

description
Overall Response Rate (ORR) was defined as the percentage of participants with a confirmed Partial Response (PR) or better as the best overall response (i.e., PR, Very Good Partial Response \[VGPR\], Complete Response \[CR\], and stringent Complete Response \[sCR\]), as assessed by the investigator per international myeloma working group (IMWG) (2016). PR is defined as ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to \<200 mg/24 h. VGPR is defined as serum and urine M-component detectable by immunofixation but not on electrophoresis OR ≥ 90% reduction in serum M-component plus urine M-component \<100 mg/24 h. CR is defined as negative immunofixation of serum and urine AND disappearance of any soft tissue plasmacytomas AND \<5% plasmacytomas in the bone marrow. sCR is defined as CR as above PLUS normal serum free light-chain (FLC) assay ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence.
measure
DE Phase: Overall Response Rate (ORR)
time Frame
Up to approximately 194 weeks
description
Clinical benefit rate was defined as the percentage of participants with a confirmed minimal response (MR) or better according to the IMWG Response Criteria. MR is \>= 25% but \< 49% reduction of serum M-protein and reduction in 24-hour urinary M-protein by 50-89%.
measure
CE Phase: Clinical Benefit Rate (CBR)
time Frame
Up to approximately 194 weeks
description
Partial Response \[PR\], Very Good Partial Response \[VGPR\], Complete Response \[CR\], and stringent Complete Response \[sCR\] were assessed by the investigator per IMWG (2016). PR defined as ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to \<200 mg/24 h. VGPR defined as serum and urine M-component detectable by immunofixation but not on electrophoresis OR ≥ 90% reduction in serum M-component plus urine M-component \<100 mg/24 h. CR defined as negative immunofixation of serum and urine AND disappearance of any soft tissue plasmacytomas AND \<5% plasmacytomas in the bone marrow. sCR defined as CR as above PLUS normal serum free light-chain (FLC) assay ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence.
measure
DE Phase: Percentage of Participants Achieving Stringent Complete Response (SCR), Complete Response (CR), Very Good Partial Response (VGPR) and Partial Response (PR)
time Frame
Up to approximately 194 weeks
description
Partial Response \[PR\], Very Good Partial Response \[VGPR\], Complete Response \[CR\], and stringent Complete Response \[sCR\] was assessed by the investigator per IMWG (2016). PR defined as ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to \<200 mg/24 h. VGPR defined as serum and urine M-component detectable by immunofixation but not on electrophoresis OR ≥ 90% reduction in serum M-component plus urine M-component \<100 mg/24 h. CR defined as negative immunofixation of serum and urine AND disappearance of any soft tissue plasmacytomas AND \<5% plasmacytomas in the bone marrow. sCR defined as CR as above PLUS normal serum free light-chain (FLC) assay ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence.
measure
CE Phase: Percentage of Participants Achieving SCR, CR, VGPR and PR
time Frame
Up to approximately 194 weeks
description
Blood samples were collected for PK analysis of belantamab mafodotin Antibody-Drug Conjugate (ADC). Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified timepoints.
measure
DE Phase: Plasma Concentrations of Belantamab Mafodotin Antibody-Drug Conjugate (ADC)
time Frame
Predose (PD), end of infusion (EOI), and 2-hour and 24-hour postdose on Cycle 1 Day 1; predose on C1D8, C1D15 and C1D22, anytime samples on C1D8 and C1D22; predose and EOI on Day 1 of Cycles 2, 4, 6, 9 and 12; and end of treatment (~194 weeks).
description
Blood samples were to be collected for PK analysis of Belantamab Mafodotin Antibody-Drug Conjugate (ADC).
measure
CE Phase: Plasma Concentration of Belantamab Mafodotin Antibody-Drug Conjugate (ADC)
time Frame
Up to approximately 194 weeks
description
Blood samples were collected for PK analysis of Belantamab mafodotin total antibody.
measure
DE Phase: Plasma Concentration of Belantamab Mafodotin Total Antibody
time Frame
Predose, end of infusion (EOI), and 2-hour and 24-hour on Cycle 1 Day 1; predose and anytime samples on Cycle 1 Days 8 and 22; predose on Cycle 1 Day 15; predose and EOI on Day 1 of Cycles 2, 4, 6, 9, and 12; and end of treatment (~194 weeks).
description
Blood samples were to be collected for PK analysis of Belantamab mafodotin plasma total antibody.
measure
CE Phase: Plasma Concentration of Belantamab Mafodotin Plasma Total Antibody
time Frame
Up to approximately 194 weeks
description
Blood samples were collected for PK analysis of belantamab mafodotin cys- monomethyl auristatin-F (cys-mcMMAF).
measure
DE Phase: Plasma Concentration of Belantamab Mafodotin Cys- Monomethyl Auristatin-F (Cys-mcMMAF)
time Frame
Predose, end of infusion (EOI), and 2-hour and 24-hour postdose on Cycle 1 Day 1; predose on Cycle 1 Days 8, 15 and 22, anytime samples on C1D8 and C1D22 ; predose and EOI on Day 1 of Cycles 2, 4, 6, 9 and 12; and end of treatment (~194 weeks).
description
Blood samples were to be collected for PK analysis of Belantamab Mafodotin Cys- Monomethyl Auristatin-F (Cys-mcMMAF)
measure
CE Phase: Plasma Concentration of Belantamab Mafodotin Cys- Monomethyl Auristatin-F (Cys-mcMMAF)
time Frame
Up to approximately 194 weeks
description
Blood samples were collected for PK analysis of Isatuximab when administered intravenously in combination with belantamab mafodotin.
measure
DE Phase: Isatuximab Concentration When Administered in Combination With Belantamab Mafodotin
time Frame
Predose on Cycle (C)1 Day (D)1, D8, D15 and D22; predose on C2D1 and C2D15; predose on C3D1 and C3D15; predose on C4D1 and C4D15; predose on C5D1, C6D1, C7D1, C8D1, C9D1 and C10D1; and end of treatment (~194 weeks).
description
Blood samples were planned to be collected for PK analysis of isatuximab when administered intravenously in combination with belantamab mafodotin.
measure
CE Phase: Isatuximab Concentration When Administered in Combination With Belantamab Mafodotin
time Frame
Up to approximately 194 weeks

Full study description

brief Summary: The primary purpose is to determine the safety and tolerability of belantamab mafodotin in combination with isatuximab, and to establish the recommended Phase 2 dose (RP2D) for the combination treatment to explore in the cohort expansion (CE) phase in participants with RRMM. This study is a sub study of the Master protocol (NCT04126200).

Source references

Source notices and limitations

Discovery and provenance

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Preserved source evidence · Not medical advice