Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05002816 | Novel Combination of Belantamab Mafodotin and Elotuzumab to Enhance Therapeutic Efficacy in Multiple Myeloma | PHASE1 | ACTIVE NOT_RECRUITING | 24 | — | — | Feb 21, 2022 | Dec 1, 2026 | May 13, 2026 | 1 | United States |
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...