Trial · NCT07150104
Registered outcomes34
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 34
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | DE Phase: Number of Participants With Dose Limiting Toxicities (DLTs) | Up to 28 days | 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 5.0). |
| Primary | DE Phase: Number of Participants With Adverse Events (AEs) | Up to approximately 137 weeks | 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. |
| Primary | DE Phase: Number of Participants With Worst-Case Hematology Results by Maximum Grade Increase Post - Baseline Relative to Baseline | Baseline (Day 1) and up to 137 weeks | Blood samples were collected for the analysis of hematology parameters. The laboratory parameters were graded according to CTCAE version 5. 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. |
| Primary | DE Phase: Number of Participants With Worst-Case Chemistry Results by Maximum Grade Increase Post - Baseline Relative to Baseline | Baseline (Day 1) and up to 137 weeks | 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; 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. CPK = creatine kinase. |
| Primary | CE Phase: Overall Response Rate (ORR) | Up to 137 weeks | 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. |
| Secondary | DE Phase: Overall Response Rate (ORR) | Up to 137 weeks | 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. |
| Secondary | CE Phase: Clinical Benefit Rate (CBR) | Up to 137 weeks | 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 defined as \>= 25% but \< 49% reduction of serum M-protein and reduction in 24-hour urinary M-protein by 50-89%. |
| Secondary | DE Phase: Percentage of Participants Achieving Stringent Complete Response (SCR), Complete Response (CR), Very Good Partial Response (VGPR) and Partial Response (PR) | Up to 137 weeks | Partial Response \[PR\], Very Good Partial Response \[VGPR\], Complete Response \[CR\], and stringent Complete Response \[sCR\] as 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. |
| Secondary | CE Phase: Percentage of Participants Achieving SCR, CR, VGPR and PR | Up to 137 weeks | Partial Response \[PR\], Very Good Partial Response \[VGPR\], Complete Response \[CR\], and stringent Complete Response \[sCR\] as assessed by the investigator per IMWG (2016). CR = negative immunofixation of serum and urine AND disappearance of any soft tissue plasmacytomas AND \<5% plasmacytomas in the bone marrow; sCR=stringent complete response, CR as above PLUS normal serum free light-chain (FLC) assay ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence; VGPR = 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; PR = ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to \<200 mg/24 h. |
| Secondary | DE Phase: Plasma Concentrations of Belantamab Mafodotin Antibody-Drug Conjugate (ADC) | Predose, end of infusion (EOI), and 2 hours postdose on Cycle 1 Day 1, anytime sample at Cycle 1 Day 4, 8, 29; Predose and EOI on Day 1 of Cycle 2, 4, 6, 9, 12; Predose on Cycle 18 Day 1; and at end of treatment (~137 weeks) | Blood samples were collected for PK analysis of belantamab mafodotin Antibody-Drug Conjugate (ADC). |
| Secondary | CE Phase: Plasma Concentrations of Belantamab Mafodotin Antibody-Drug Conjugate (ADC) | Up to 137 weeks | Blood samples were to be collected for PK analysis of Belantamab Mafodotin Antibody-Drug Conjugate (ADC). |
| Secondary | DE Phase: Plasma Concentration of Belantamab Mafodotin Total Antibody | Predose, end of infusion (EOI), and 2 hours postdose on Cycle 1 Day 1, anytime sample at Cycle 1 Day 4, 8, 29; Predose and EOI on Day 1 of Cycle 2, 4, 6, 9, 12; Predose on Cycle 18 Day 1; and at end of treatment (~137 weeks) | Blood samples were collected for PK analysis of Belantamab mafodotin total antibody. |
| Secondary | CE Phase: Plasma Concentration of Belantamab Mafodotin Plasma Total Antibody | Up to 137 weeks | Blood samples were to be collected for PK analysis of Belantamab mafodotin plasma total antibody. |
| Secondary | DE Phase: Plasma Concentrations of Belantamab Mafodotin Cys- Monomethyl Auristatin-F (Cys-mcMMAF) | Predose, end of infusion (EOI), and 2 hours postdose on Cycle 1 Day 1, anytime sample at Cycle 1 Day 4, 8, 29; Predose and EOI on Day 1 of Cycle 2, 4, 6, 9, 12; Predose on Cycle 18 Day 1; and at end of treatment (~137 weeks) | Blood samples were collected for PK analysis of belantamab mafodotin cys- monomethyl auristatin-F (cys-mcMMAF). |
| Secondary | CE Phase: Plasma Concentrations of Belantamab Mafodotin Cys- Monomethyl Auristatin-F (Cys-mcMMAF) | Up to 137 weeks | Blood samples were to be collected for PK analysis of Belantamab Mafodotin Cys- Monomethyl Auristatin-F (Cys-mcMMAF) |
| Secondary | DE Phase: Nirogacestat Concentration When Administered in Combination With Belantamab Mafodotin | Predose, 30 mins, 1 hour, 2 hours, and 4 hours post dose on Cycle 1 Day -2; Predose on Cycle 1 Day 1, 4, 8; Predose, 30 mins, 1 hour, 2 hours, and 4 hours post dose on Cycle 2 Day 1 | Blood samples were collected for PK analysis of Nirogacestat when administered orally in combination with belantamab mafodotin. |
| Secondary | CE Phase: Nirogacestat Concentration When Administered in Combination With Belantamab Mafodotin | Up to 137 weeks | Blood samples were to be collected for PK analysis of Nirogacestat when administered orally in combination with belantamab mafodotin. |
| Secondary | DE Phase: Number of Participants With Post-baseline Positive Anti-drug Antibodies (ADAs) Against Belantamab Mafodotin | Up to 137 weeks | Serum samples collected for the analysis of the presence of ADAs using validated immunoassays. All samples were tested in screening assay, and positive samples were further characterized for antibody titers. |
| Secondary | CE Phase: Number of Participants With Post-baseline Positive ADAs Against Belantamab Mafodotin | Up to 137 weeks | Serum samples were to be collected for the analysis of the presence of ADAs using validated immunoassays. All samples were to be tested in screening assay, and positive samples were to be further characterized for antibody titers. |
| Secondary | DE Phase: Titer of ADAs Against Belantamab Mafodotin | Up to 137 weeks | Serum samples were collected for the analysis of the presence of ADAs using validated immunoassays. All samples were further tested in screening assay, and positive samples were further characterized for antibody titers. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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