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

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Brief 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.

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase I

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

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Study Stats
Protocol No.
22-000340
Category
Hematology-Oncology
Oncology
Contact
Bruck Habtemariam
Location
  • UCLA Westwood
For Providers
NCT No.
NCT04398485
For detailed technical eligibility, visit ClinicalTrials.gov.