Clinical trial · Interventional
A Study of Filanesib (ARRY-520) and Carfilzomib in Patients With Advanced Multiple Myeloma
NCT01989325CI-TRIAL-00047174completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a Phase 2 study during which patients with advanced multiple myeloma will receive either carfilzomib alone (single-agent) or carfilzomib in combination with investigational study drug filanesib (ARRY-520). Patients will be followed to determine the effectiveness of both single-agent carfilzomib and carfilzomib + filanesib in treating myeloma. Patients will be allowed to crossover from single-agent carfilzomib to carfilzomib + filanesib if disease progression occurs. Approximately 75 patients from the US will be enrolled in this study.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Multiple Myeloma | Multiple Myeloma | CURATED_BROADER | 0.78 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carfilzomib, proteasome inhibitor; intravenous | Drug | — | UNRESOLVED |
| Dexamethasone, steroid; oral or intravenous | Drug | — | UNRESOLVED |
| Filanesib, KSP(Eg5) inhibitor; intravenous | Drug | — | UNRESOLVED |
| Filgrastim, granulocyte-colony stimulating factor (G-CSF); subcutaneous | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Carfilzomib + Filanesib
- description
- 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.
- interventionNames
- Drug: Carfilzomib, proteasome inhibitor; intravenous
- Drug: Filanesib, KSP(Eg5) inhibitor; intravenous
- Drug: Dexamethasone, steroid; oral or intravenous
- Drug: Filgrastim, granulocyte-colony stimulating factor (G-CSF); subcutaneous
- type
- EXPERIMENTAL
- label
- Carfilzomib
- description
- Single agent arm. Patients will be hydrated prior to and following carfilzomib administration and will be premedicated with dexamethasone, per the carfilzomib prescribing information.
- interventionNames
- Drug: Carfilzomib, proteasome inhibitor; intravenous
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Key Inclusion Criteria: * Confirmed multiple myeloma with measurable disease. * Disease refractory to last myeloma regimen. * Patients must have received at least 2 prior treatment regimens, including bortezomib and an IMiD (e.g., lenalidomide, thalidomide, pomalidomide). Induction therapy and stem cell transplant ± maintenance are to be considered as a single regimen. * Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 within 14 days prior to first dose of study treatment. * Adequate hematology, liver and renal function laboratory values within 14 days prior to first dose of study treatment. * Additional criteria exist. Key Exclusion Criteria: * Prior treatment with carfilzomib, filanesib, or any other KSP inhibitor. * Past or current plasma cell leukemia. * Primary amyloidosis (amyloidosis associated with multiple myeloma is allowed). * POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes). * Ongoing Grade 3 or Grade 4 peripheral neuropathy, or Grade 2 peripheral neuropathy with pain despite appropriate interventions, within 28 days prior to first dose of study treatment. * Autologous or allogeneic stem cell or bone marrow transplant within 3 months prior to first dose of study treatment. * Concomitant malignancies or previous malignancies (other than multiple myeloma) with less than a 2-year disease-free interval at the time of first dose of study treatment. Patients with adequately resected basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix or breast, or Stage 1 prostate cancer are eligible irrespective of the time of diagnosis. * Known pulmonary hypertension of any severity. * Concurrent cardiac disease that, in the judgment of the Investigator, would make the patient inappropriate for study participation. * Known positive serology for the human immunodeficiency virus (HIV), active hepatitis B and/or hepatitis C. * Acute active infection requiring treatment. * Additional criteria exist.
References
Publications (0)
Data not yet available
No reference posted for this study.