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INCB053914 will have a dose escalation in a 3 + 3 design.

INCB053914 50 mg bis in die (BID)

INCB053914 65 mg BID

INCB053914 80 mg BID

Binod Dhakal, MD

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.

INCB053914 and Pomalidomide With Dexamethasone for Relapsed and/or Refractory Multiple Myeloma

A Phase I Study of INCB053914 (Pan-PIM Kinase Inhibitor) and Pomalidomide With Dexamethasone in Patients With Relapsed and/or Refractory Multiple Myeloma

The safety of INCB053914 with pomalidomide and dexamethasone in participants with relapsed and/or refractory multiple myeloma.

Based on number of dose-limiting toxicities.

This measure is the number of months participants remain free from evidence of disease. This will be captured using International Myeloma Working Group criteria.

Overall survival is defined from the number of months from initiation of treatment until death due to any cause. Participants without an observed progression / death event will be censored at the last follow-up or end of study.

The number of months from the date of first documented response (complete or partial) to the time of the next relapse/progression. This will be captured using International Myeloma Working Group criteria.

The number of subjects with negative serum C terminal telopeptide type-X (CTX). This is determined by a blood draw.

The number of subjects with positive serum N terminal propeptide of procollagen (P1NP). This is determined by a blood draw.

This will be determined by positron emission tomography (PET) /MRI scans, using RECIST.

Medical College of Wisconsin

Assistant Professor

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
INCB053914 and Pomalidomide With Dexamethasone for Relapsed and/or Refractory Multiple Myeloma	NCT04355039	Refractory Mult... Relapse Multipl...	Pomalidomide Dexamethasone INCB053914 50 m... INCB053914 65 m... INCB053914 80 m...	18 Years -	Medical College of Wisconsin
INCB053914 and Pomalidomide With Dexamethasone for Relapsed and/or Refractory Multiple Myeloma	NCT04355039	Refractory Mult... Relapse Multipl...	Pomalidomide Dexamethasone INCB053914 50 m... INCB053914 65 m... INCB053914 80 m...	18 Years -	Medical College of Wisconsin
INCB053914 and Pomalidomide With Dexamethasone for Relapsed and/or Refractory Multiple Myeloma	NCT04355039	Refractory Mult... Relapse Multipl...	Pomalidomide Dexamethasone INCB053914 50 m... INCB053914 65 m... INCB053914 80 m...	18 Years -	Medical College of Wisconsin

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