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Monoclonal Antibodies

REGN5459 for Multiple Myeloma

Phase 1 & 2
Waitlist Available
Research Sponsored by Regeneron Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Serum creatinine clearance by Cockcroft-Gault >30 mL/min. A patient with a creatinine clearance by Cockcroft-Gault who does not meet eligibility criteria may be considered for enrollment if a measured creatinine clearance is >30 mL/min
Progression on or after at least 3 lines of therapy, or intolerance of therapy, including a proteasome inhibitor, an Immunomodulatory imide drug (IMiD), and an anti-CD38 antibody, OR
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 104 weeks
Awards & highlights

Study Summary

This trial is studying a drug called REGN5459 to see if it is safe and effective in treating patients with relapsed or refractory multiple myeloma who have exhausted all other treatment options. The trial has two parts: in the first part, the researchers will determine the best dose of the drug to give; in the second part, they will study how well the drug works.

Who is the study for?
Adults with relapsed or refractory Multiple Myeloma who have tried at least three lines of therapy, including a proteasome inhibitor, an IMiD, and an anti-CD38 antibody. They should not have brain involvement by MM or certain neurological conditions, no recent seizures, adequate heart function, and no prior BCMA-targeted therapies. Patients must also be free from uncontrolled infections like HIV or hepatitis.Check my eligibility
What is being tested?
The trial is testing REGN5459 as a solo treatment for Multiple Myeloma in two phases: Phase 1 to find the safest dose with acceptable side effects (dose-limiting toxicities) and Phase 2 to see how well it works against cancer (measuring response rate). The study will also look at how long the benefits last and any impacts on quality of life.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system's response to the drug which can affect various organs. Specific side effects are not listed but generally may involve fatigue, digestive issues, blood disorders based on similar treatments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My kidney function, measured by creatinine clearance, is above 30 mL/min.
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I've had 3 types of treatments for my condition and they didn't work or I couldn't tolerate them.
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I have multiple myeloma and no remaining treatment options that could help.
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My myeloma can be measured for treatment response.
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I am fully active or can carry out light work.
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My liver is functioning well according to recent tests.
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My IgA myeloma can't be measured by M-protein, but my IgA levels are high enough to track over time.
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My condition worsened after anti-CD38 treatment and doesn't respond to two other drug types.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 104 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 104 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence and severity of adverse events of special interest (AESI) with REGN5459 treatment period
Incidence and severity of treatment-emergent adverse events (TEAEs) during REGN5459 treatment period
Incidence of dose-limiting toxicities (DLTs) from the first dose through the end of the DLT observation period
+1 more
Secondary outcome measures
Change in patient-reported general health status per EQ-5D-3L
Change in patient-reported global health status/QOL per EORTC QLQ-C30
Concentrations of REGN5459 in the serum over time
+12 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: REGN5459Experimental Treatment1 Intervention
Cohorts of multiple REGN5459 dose levels

Find a Location

Who is running the clinical trial?

Regeneron PharmaceuticalsLead Sponsor
613 Previous Clinical Trials
379,416 Total Patients Enrolled
8 Trials studying Multiple Myeloma
1,342 Patients Enrolled for Multiple Myeloma
Clinical Trials InvestigatorStudy DirectorRegeneron Pharmaceuticals

Media Library

REGN5459 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04083534 — Phase 1 & 2
Multiple Myeloma Research Study Groups: REGN5459
Multiple Myeloma Clinical Trial 2023: REGN5459 Highlights & Side Effects. Trial Name: NCT04083534 — Phase 1 & 2
REGN5459 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04083534 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many distinct locations are being utilized for this clinical experiment?

"Right now, the study is enrolling patients at 7 centres located in Ann Arbor, Milwaukee and Indianapolis as well as 4 other metropolitan areas. To reduce travel strain on participants, it would be beneficial to select a clinic that's close by."

Answered by AI

Are there any opportunities for enrolment in this clinical trial?

"This study, initially posted on September 26th 2019 and last revised August 16th 2022, is not currently recruiting. However, 807 other studies are in the process of enrolling patients at this time."

Answered by AI

What results are expected from this trial?

"Regeneron Pharmaceuticals, the study's sponsor, has identified a series of primary and secondary endpoints to be measured over an Up-to 35 Day period. The primary outcome is Objective Response Rate (ORR) as noted by International Myeloma Working Group criteria while Secondary Outcomes include Incidence and severity of Treatment Emergent Adverse Events during treatment with REGN5459, ORR assessed using IMWG guidelines for Phase 1 Only patients and Duration Of Response utilising IMWG protocols for both Phases 1 & 2 participants."

Answered by AI
~10 spots leftby Aug 2025