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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02092922 | A Phase 2 Trial of Filanesib in Relapsed/Refractory Multiple Myeloma (AfFIRM) | PHASE2 | COMPLETED | 154 | — | — | May 1, 2014 | Sep 5, 2017 | Oct 19, 2020 | 60 | United States, Belgium +6 |
| NCT01989325 | A Study of Filanesib (ARRY-520) and Carfilzomib in Patients With Advanced Multiple Myeloma | PHASE2 | COMPLETED | 77 | — | — | Nov 1, 2013 | May 1, 2016 | Sep 16, 2020 | 22 | United States |
| Arm | Type | Description |
|---|---|---|
| Filanesib | EXPERIMENTAL | - |
| Carfilzomib + Filanesib | EXPERIMENTAL | Single agent + Carfilzomib arm. Patients will be hydrated prior to and following carfilzomib administration and will be premedicated with dexamethasone, per the carfilzomib prescribing information. Filgrastim to be administered per the approved product prescribing information and institutional guidelines. |
| Carfilzomib | EXPERIMENTAL | Single agent arm. Patients will be hydrated prior to and following carfilzomib administration and will be premedicated with dexamethasone, per the carfilzomib prescribing information. |
| Name | Type | Description |
|---|---|---|
| Filanesib, KSP (Eg5) inhibitor; intravenous | DRUG | multiple dose, single schedule |
| Filgrastim, granulocyte-colony stimulating factor (G-CSF); subcutaneous | DRUG | standard of care |
| Carfilzomib, proteasome inhibitor; intravenous | DRUG | multiple dose, single schedule |
| Filanesib, KSP(Eg5) inhibitor; intravenous | DRUG | multiple dose, single schedule |
| Dexamethasone, steroid; oral or intravenous | DRUG | as indicated, per the carfilzomib prescribing information |
Key Inclusion Criteria: * Patients with confirmed multiple myeloma whose treatment history must include all of the following: 1. Received at least 2 prior lines of therapy (induction therapy and stem cell transplant ± maintenance are to be considered a single line of therapy). 2. Received at l...