NCT04398485CompletedPhase 1
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
Source: ClinicalTrials.gov · Last updated 31 Oct 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 23 (actual)
- First submitted
- 11 May 2020
- Start date
- 20 Jan 2021
- Primary completion date
- 30 Sept 2024
- Lead sponsor
- Ionis Pharmaceuticals, Inc.
- Diseases
- Multiple myeloma
- NCT number
- NCT04398485
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 23
- From 20 Jan 2021 to the primary completion date, 30 Sept 2024
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Lab values
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Levine Cancer Institute Coordinator of this site? Confirm its status | Charlotte | United States | Unknown status |
| Barbara Ann Karmanos Cancer Institute Coordinator of this site? Confirm its status | Detroit | United States | Unknown status |
| University of California San Diego Moores Cancer Center Coordinator of this site? Confirm its status | La Jolla | United States | Unknown status |
| UCLA Rrmc Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Cedars-Sinai Medical Center Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Washington University School of Medicine in Saint Louis Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.