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

Completed · Phase 1

Conditions studied: Relapsed Multiple Myeloma, Refractory Multiple Myeloma

In brief

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.

Key facts

Study ID

NCT04398485

Run by

Ionis Pharmaceuticals, Inc.

People needed

23

Starts

2021-01-20

Expected to finish

2024-09-30

Last updated by the study team

2024-10-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Aged ≥ 18 years at the time of informed consent
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Measurable multiple myeloma (MM)
• In need of systemic treatment for MM and either is refractory to or has failed treatment with, is intolerant to or has refused, or is not otherwise a candidate in the opinion of the Investigator, for any of the currently available established therapies known to provide clinical benefit in relapsed/refractory MM. Refractory to treatment is defined as documented MM disease progression while on or within 60 days from the last dose (LD) of treatment

You may not qualify if…

• Screen laboratory results as follows, or any other clinically significant abnormalities in screen laboratory values that would render a participant unsuitable for inclusion
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2 × upper limit of normal (ULN)
• Total bilirubin > 1.3 × ULN
• Absolute neutrophil count ≤ 1.0 1000/cubic millimeter (k/mm\^3)
• Platelet count < 50 k/mm\^3
• Hemoglobin < 8.0 g/dL
• Estimated glomerular filtration rate (eGFR) < 50 milliliters per minute (mL/min)/1.73 square meter (m\^2)
• Urine albumin creatinine ratio > 100 mg/g
• History of or current plasma cell leukemia, POEMS (polyneuropathy, organomegaly, endocrinopathy, and skin changes) syndrome, solitary bone or extramedullary plasmacytoma as the only evidence for plasma cell dyscrasia, myelodysplastic syndrome or a myeloproliferative neoplasm
• Uncontrolled hypertension (systolic pressure ≥ 160 mm of mercury (mm Hg) and/or diastolic pressure ≥ 100 mm Hg)
• Presence of a bleeding disorder or an underlying disease state associated with active bleeding.

Where it is running

• University of California San Diego Moores Cancer Center — La Jolla, California, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• UCLA Rrmc — Los Angeles, California, United States
• Barbara Ann Karmanos Cancer Institute — Detroit, Michigan, United States
• Washington University School of Medicine in Saint Louis — St Louis, Missouri, United States
• Levine Cancer Institute — Charlotte, North Carolina, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.