Status:
COMPLETED
A Study of ION251 Administered to Patients With Relapsed/Refractory Multiple Myeloma
Lead Sponsor:
Ionis Pharmaceuticals, Inc.
Conditions:
Relapsed Multiple Myeloma
Refractory Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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.
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 repeat...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2024
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT04398485
Start Date
January 20 2021
End Date
September 30 2024
Last Update
October 31 2024
Active Locations (6)
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1
University of California San Diego Moores Cancer Center
La Jolla, California, United States, 92093
2
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
3
UCLA Rrmc
Los Angeles, California, United States, 90095
4
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201