NCT04355039

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

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Medical College of Wisconsin · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Refractory Multiple Myeloma
• Relapse Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Pomalidomide	4 mg Days 1-21
DRUG	Dexamethasone	40 mg Days 1, 8, 15 and 22
DRUG	INCB053914 50 mg bis in die (BID)	Dose level 0: 50 mg BID
DRUG	INCB053914 65 mg BID	Dose level 1: 65 mg BID
DRUG	INCB053914 80 mg BID	Dose level 2: 80 mg BID

Timeline

• Start date: 2021-07-01
• Primary completion: 2023-07-01
• Completion: 2024-07-01
• First posted: 2020-04-21
• Last updated: 2020-08-19