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Elotuzumab · 1 trial · 1 indication
Study patients will be enrolled and treated in cohorts of size 4 with maximum of 12 patients in the Phase I portion of the trial with possible dose de-escalation of belantamab mafodotin plus a fixed level of elotuzumab. Starting dose of belantamab mafodotin will be 1.9 mg/kg q4w. If the DLT rate hits de-escalation boundary (≥ 29.8%), four more patients will be enrolled for lower dose level with 1.9 mg/kg q8w; further dose reduction to 1.4mg/kg every 8 weeks will be planned for ongoing toxicity. Otherwise next cohort of 4 will be treated at same dose. The MTD will be determined once the maximum sample size of 12 for phase I portion is reached or stop the trial if 8 patients are treated at the initial dose without need of de-escalation.
DLT is defined as Grade 3 or greater febrile neutropenia lasting \>48 h despite adequate treatment, Grade 4 thrombocytopenia less than 25 accompanied by clinically significant bleeding, any Grade 3 or greater non-hematologic toxicity (other than corneal events) which is more severe than expected for an individual agent or which does not resolve with appropriate supportive treatment within 48 hours, any Grade 3 or greater non-hematologic laboratory value if the abnormality leads to hospitalization, grade 4 Keratopathy Visual Acuity (KVA) Scale, and liver toxicity meeting prespecified liver stopping criteria
| Arm | Type | Description |
|---|---|---|
| Belantamab Mafodotin and Elotuzumab Arm | EXPERIMENTAL | Elotuzumab will be administered via intravenous infusion at an established dose of 10 mg/kg on days 1, 8, 15, 22 every 28 days for cycles 1 and 2, followed by 20mg/kg on day 1 of each cycle thereafter, cycles repeated every 28 days. Belantamab mafodotin will be administered via IV infusion. There will be 3 dose levels for belantamab mafodotin, with the starting dose of 1.9 mg/kg IV at every 4 week interval. Up to 12 subjects will be treated at this dose level. If the initial dose is found to be too toxic, dose of belantamab mafodotin 1.9 mg/kg every 8 weeks will be tested, further dose reduction to 1.4mg/kg every 8 weeks will be administered. |
| Name | Type | Description |
|---|---|---|
| Elotuzumab | DRUG | Elotuzumab will be administered via intravenous infusion at an established dose of 10 mg/kg on days 1, 8, 15, 22 every 28 days for cycles 1 and 2, followed by 20mg/kg on day 1 of each cycle thereafter, cycles repeated every 28 days. |
| Belantamab mafodotin | DRUG | Belantamab mafodotin will be administered via IV infusion on day 1 of each 28 day cycle. There will be 3 dose levels for belantamab mafodotin, with the starting dose of 1.9 mg/kg IV at every 4 week interval. Up to 12 subjects will be treated at this dose level. If the initial dose is found to be too toxic, dose of belantamab mafodotin 1.9 mg/kg every 8 weeks will be tested, further dose reduction to 1.4mg/kg every 8 weeks will be administered. Following the dose evaluation, there will be a dose expansion cohort wtih 12 additional subjects. There is no dose escalation planned in this study. |
Inclusion Criteria: 1. Participant must have MM that has relapsed after or is refractory to at least 3 prior lines of therapy. Relapsed/refractory disease as defined by IMWG criteria. 2. Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2 3. Participant must...
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Elotuzumab is an investigational antibody being studied for the treatment of Multiple Myeloma. It is currently in Phase 1 clinical development, with an active trial evaluating its use in combination with Belantamab Mafodotin to enhance therapeutic efficacy in patients with this condition.
Elotuzumab is a monoclonal antibody, classified as a -mab (antibody) modality. Its specific molecular target is not disclosed in available information, but it is being investigated for its role in Multiple Myeloma therapy as part of a combination regimen.
Elotuzumab is being developed by GSK plc, a biopharmaceutical company listed on the stock exchange under the ticker GSK. The company is conducting clinical research to evaluate the drug's safety and efficacy in patients with Multiple Myeloma.
Elotuzumab is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The ongoing Phase 1 trial is active but not recruiting participants, with a planned enrollment of 24 patients.
Elotuzumab is being studied in a Phase 1 clinical trial with the identifier NCT05002816. The trial is titled "Novel Combination of Belantamab Mafodotin and Elotuzumab to Enhance Therapeutic Efficacy in Multiple Myeloma" and is being conducted in the United States. The study is active but not recruiting, and it is not randomized or blinded.
No, Elotuzumab is not the same as Belantamab Mafodotin. They are distinct drugs being studied together in a combination regimen for Multiple Myeloma. The clinical trial NCT05002816 evaluates the combination of these two agents to assess their potential therapeutic benefit in patients.