Refractory Multiple Myeloma Clinical Trial
Official title:
A Phase I Study of INCB053914 (Pan-PIM Kinase Inhibitor) and Pomalidomide With Dexamethasone in Patients With Relapsed and/or Refractory Multiple Myeloma
This is a prospective, single-center, open-label phase Ib study aimed at determining a recommended phase II dose of INCB053914 and pomalidomide with dexamethasone. The trial will follow a 3 + 3 phase I dose-escalation design.
This is a prospective, single-center phase I clinical study aimed at determining the
maximum-tolerated dose and safety of INCB053914 (pan-PIM kinase inhibitor) and pomalidomide
with dexamethasone in patients with relapsed and/or refractory multiple myeloma. Three
candidate dose levels of INCB053914, 50 mg, 65 mg, and 80 mg twice daily will be considered.
The research team will utilize a 3+3 design to determine a safe dose of INCB053914 combined
with fixed doses of pomalidomide (4 mg Days 1- Days 21) and dexamethasone (40 mg Days 1, 8,
15, 22).
The first three patients will be treated with INCB053914 twice daily at a dose of 50 mg.
Dose-limiting toxicity (DLT) assessment during the first 28-day cycle will be the basis for
maximum-tolerated dose assessment.
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