Overview

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

Status:
Recruiting
Trial end date:
2024-01-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Ionis Pharmaceuticals, Inc.
Criteria
Inclusion Criteria:

1. Aged ≥ 18 years at the time of informed consent

2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

3. Measurable multiple myeloma (MM)

4. 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:

1. 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

2. 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

3. Uncontrolled hypertension (systolic pressure ≥ 160 mm of mercury (mm Hg) and/or
diastolic pressure ≥ 100 mm Hg)

4. Presence of a bleeding disorder or an underlying disease state associated with active
bleeding.