Dose Schedule Study of BCMA Bispecific Antibody, Elranatamab, for Newly Diagnosed Immunoglobulin Light Chain (AL) Amyloidosis

Conditions

• Amyloid Light-chain Amyloidosis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• BCMA bispecific — DRUG
  All Participants will receive standard step-up dosing (SUD) of BCMA bispecific (elranatamab) in Cycle 1. They will then have 5 additional 28-day cycles on two different dose schedules, for a total duration of 6 months.

Study Details

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).

Key Dates

Start date

Jun 30, 2026

Status verified

Apr 2026

Primary completion

Jun 30, 2031

Completion

Jun 30, 2031

Study Design

Enrollment

64 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm A: SUD followed by Arm A dose scheduling
  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.
• Experimental: Arm B: SUD followed by Arm B dose scheduling
  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.

Primary Outcome Measure

Efficacy of BCMA bispecific in treating newly diagnosed AL Amyloid, as measured by hematologic complete response (hCR) rates [ Time Frame: At end of therapy (after 6 cycles, up to 6 months) ]

Central Contacts

• Sandra Mazzoni, DO
  216-444-8111
  [email protected]

Locations (2)

Find similar trials in Rochester, MN

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