Sub-study of Belantamab Mafodotin (GSK2857916) in Combination With Isatuximab in Participants With RRMM
Condition(s) studied
Investigational drug(s) / intervention(s)
Belantamab mafodotin: Belantamab mafodotin will be administered.
Isatuximab: Isatuximab will be administered.
Study 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).
Eligibility
Primary outcome measure(s)
- Dose Expansion (DE) Phase: Number of Participants With Dose Limiting Toxicities (DLT) — 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 (v) 5.0. - DE Phase: Number of Participants With Adverse Events (AEs) — Up to approximately 194 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 approximately 194 weeks
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. - 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 approximately 194 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. 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. - Cohort Expansion (CE) Phase: Overall Response Rate (ORR) — Up to approximately 194 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 (19)
| Facility | City | Region | Status |
|---|---|---|---|
| GSK Investigational Site | Atlanta | Georgia | |
| GSK Investigational Site | Boston | Massachusetts | |
| GSK Investigational Site | Grand Rapids | Michigan | |
| GSK Investigational Site | Madison | Wisconsin | |
| GSK Investigational Site | Fitzroy | Victoria | |
| GSK Investigational Site | Salvador | Estado de Bahia | |
| GSK Investigational Site | São Paulo | Brazil | |
| GSK Investigational Site | Toronto | Ontario | |
| GSK Investigational Site | Villejuif | France | |
| GSK Investigational Site | Athens | Greece | |
| GSK Investigational Site | Mexico City | Mexico | |
| GSK Investigational Site | Oslo | Norway | |
| GSK Investigational Site | Seoul | South Korea | |
| GSK Investigational Site | Seoul | South Korea | |
| GSK Investigational Site | Ulsan | South Korea | |
| GSK Investigational Site | Madrid | Spain | |
| GSK Investigational Site | Madrid | Spain | |
| GSK Investigational Site | Pozuelo de AlarcOn Madr | Spain | |
| GSK Investigational Site | Falun | Sweden |
More GlaxoSmithKline trials in Canada
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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 NCT07217184 on ClinicalTrials.gov ↗ ← All trials in Canada