NCT04398485

A Study of ION251 Administered to Patients With Relapsed/Refractory Multiple Myeloma

A Phase 1 Study of ION251 Administered by Intravenous Infusion to Patients With Relapsed/Refractory Multiple Myeloma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Ionis Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the maximum-tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of ION251 in patients with relapsed/refractory multiple myeloma.

Detailed description

This is a two-part, multi-center first in human study of ION251 in up to 80 participants. Part 1 will use a 3+3 dose-escalation scheme in sequential cohorts to determine the MTD and RP2D during repeated 28-day treatment cycles. MTD will be determined by the number of participants with AEs meeting the dose-limiting toxicity (DLT) criteria during Cycle 1. The MTD determined in Part 1 will be used with other variables to inform a RP2D for participants proceeding to Part 2 for further assessments in the safety, tolerability and anti-myeloma activity.

Conditions

• Relapsed Multiple Myeloma
• Refractory Multiple Myeloma

Interventions

Type	Name	Description
DRUG	ION251	ION251 administered by IV infusion

Timeline

• Start date: 2021-01-20
• Primary completion: 2024-09-30
• Completion: 2024-09-30
• First posted: 2020-05-21
• Last updated: 2024-10-31

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study