Elranatamab for AL Amyloidosis
What You Need to Know Before You Apply
What is the purpose of this trial?
This research study is for people who have newly diagnosed with AL (light chain) amyloidosis and have not yet received any treatment for this condition. The purpose of this study is to evaluate whether elranatamab, a type of immunotherapy drug, can produce deep remissions and organ recovery in people with newly diagnosed AL amyloidosis, and to compare two different dosing schedules.
Elranatamab (brand name ELREXFIO™) is an investigational (experimental) drug in the setting of AL amyloidosis. It works by connecting immune cells (T-cells) directly to the abnormal plasma cells that are causing amyloidosis, triggering the immune system to destroy those cells. It is not approved by the Food and Drug Administration (FDA) for use in AL amyloidosis.
Participants in this study will receive elranatamab as a series of injections under the skin (subcutaneously) over 6 treatment cycles (approximately 6 months). Treatment begins with inpatient "step-up" doses designed to reduce side effects, followed by two different dosing schedules based on which study arm participants are randomly assigned to. Participants will have regular blood tests, physical exams, bone marrow biopsies, and heart assessments throughout the study, and follow-up visits for up to 2 years after treatment ends.
This study is randomized, meaning that participants will be assigned by chance (similar to a coin flip) to one of two treatment arms. Participants cannot choose their arm.
Participation in this research will last approximately 6 months of active treatment, followed by follow-up visits for up to 2 years (with an option to extend to 5 years).
Who Is on the Research Team?
Sandra Mazzoni, DO
Principal Investigator
Case Comprehensive Cancer Center, Cleveland Clinic
Are You a Good Fit for This Trial?
Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive elranatamab as a series of injections over 6 treatment cycles, approximately 6 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Elranatamab
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Participants in Arm B will receive standard step-up dosing (SUD) with one dose a week after SUD, followed by Arm B dose scheduling with a fixed duration of 6 months of BCMA bispecific.
Participants in Arm A will receive standard step-up dosing (SUD) with one dose a week after SUD, followed by Arm A dose scheduling with a fixed duration of 6 months of BCMA bispecific.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Case Comprehensive Cancer Center
Lead Sponsor
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