drugset / Trial / NCT01537861

Filgrastim in Treating Patients With Bortezomib-, Carfilzomib-, or IMID-Refractory Multiple Myeloma

NCT01537861 ↗

Phase 0 Terminated 7 enrolled Washington University School of Medicine
NaSingle-groupOpen-labelTreatment

Summary

Based on the pre-clinical data the investigators hypothesize that G-CSF treatment in patients with multiple myeloma will generate a 'hostile' bone marrow microenvironment for myeloma cells, depriving them of key support signals and rendering them more sensitive to chemotherapy. The investigators therefore propose to do an initial pilot study 1) to explore the safety of the combination of G-CSF and bortezomib-, carfilzomib-, or IMID-based treatment regimens in patients with bortezomib-, carfilzomib-, or IMID-refractory myeloma and 2) to generate correlative data for a subsequent larger study looking at the combination.

Timeline

Start
2012-06
Primary completion
2014-02
Completion
2014-12

Outcome

Outcome not reported

Stopped: “Unexpected toxicity (2 early deaths)”

Drugs

EvaluationDrugModalityDoseRoute
Subject filgrastim Protein / enzyme biologic 5 ug/kg —
Background Bortezomib Small molecule — —
Background Carfilzomib Other / unclassified — —
Background Cyclophosphamide Other / unclassified — Oral
Background Dexamethasone Small molecule — —
Background Lenalidomide Other / unclassified — —
Background Pomalidomide Other / unclassified — —
Background Thalidomide Other / unclassified — —

Indications