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REGN5459 for Multiple Myeloma
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- Your heart's pumping ability is less than 40% according to a heart imaging test.My kidney function, measured by creatinine clearance, is above 30 mL/min.I've had 3 types of treatments for my condition and they didn't work or I couldn't tolerate them.You are expected to live for at least 6 more months.A patient with a type of multiple myeloma that does not produce abnormal proteins in the blood may be able to join the study after talking with the people running the study about how to check if the treatment is working for them.I have had a stem cell transplant from a donor or my own within the past 12 weeks.Your blood counts should be high enough, with platelets above 50, ANC above 1.0, and hemoglobin above 8.0.I have not had treatments targeting BCMA for my cancer.I have hepatitis B but it's under control and I'm on anti-viral therapy.I have had hepatitis C but it is now under control.I have multiple myeloma and no remaining treatment options that could help.I have not had a neurodegenerative condition, CNS movement disorder, or seizure in the last year.I do not have an uncontrolled HIV, HBV, or HCV infection.My myeloma can be measured for treatment response.I am fully active or can carry out light work.My liver is functioning well according to recent tests.If you have HIV, it must be under control with low viral levels and a healthy CD4 count.My IgA myeloma can't be measured by M-protein, but my IgA levels are high enough to track over time.My condition worsened after anti-CD38 treatment and doesn't respond to two other drug types.You have high levels of specific proteins in your blood or urine.I have brain lesions or meningeal involvement due to multiple myeloma.
- Group 1: REGN5459
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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