Sub-study of Belantamab Mafodotin (GSK2857916) in Combination With Nirogacestat, Lenalidomide, and Dexamethasone in Participants With RRMM
Condition(s) studied
Investigational drug(s) / intervention(s)
Belantamab mafodotin: Belantamab mafodotin will be administered.
Nirogacestat: Nirogacestat will be administered.
Lenalidomide: Lenalidomide will be administered.
Dexamethasone: Dexamethasone will be administered.
Study summary
The primary purpose is to determine the safety and tolerability of belantamab mafodotin in combination with nirogacestat, lenalidomide, and dexamethasone, and to establish the recommended Phase 2 dose for 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).
Eligibility
Primary outcome measure(s)
- 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). - DE Phase: Number of Participants With Adverse Events (AEs) — Up to 143 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. - 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 143 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. - 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 143 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. GGT = gamma glutamyl transferase. - CE Phase: Overall Response Rate (ORR) — Up to 143 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.
Trial sites (12)
| Facility | City | Region | Status |
|---|---|---|---|
| GSK Investigational Site | Boston | Massachusetts | |
| GSK Investigational Site | Salvador | Estado de Bahia | |
| GSK Investigational Site | São Paulo | Brazil | |
| GSK Investigational Site | Halifax | Nova Scotia | |
| GSK Investigational Site | Villejuif | France | |
| GSK Investigational Site | Hamburg | Germany | |
| GSK Investigational Site | Athens | Greece | |
| GSK Investigational Site | Mexico City | Mexico | |
| GSK Investigational Site | Seoul | South Korea | |
| GSK Investigational Site | Seoul | South Korea | |
| GSK Investigational Site | Seoul | South Korea | |
| GSK Investigational Site | Ulsan | South Korea |
On this site
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07150091 on ClinicalTrials.gov ↗ ← All trials in South Korea