Condition: Immunoglobulin Light Chain (AL) Amyloidosis · Sponsor: AbbVie
Immunoglobulin light chain (AL) amyloidosis is the most common form of systemic amyloidosis. AL amyloidosis has many root causes and is characterized by the overproduction of AL that are secreted by clonal bone marrow plasma cells. This is a study to determine adverse events and change in disease activity in adult participants with AL amyloidosis treated with ABBV-383. Etentamig (ABBV-383) is an investigational drug being developed for the treatment of AL amyloidosis. This study in broken into 2 parts (dose escalation and dose expansion) with 4 arms. During dose escalation (arms 1-3) participants will receive 1 of 3 doses of ABBV-383 to determine the part 2 dose. After completion of the dose escalation portion of the study, the dose expansion (part 2) portion of the study will begin. One arm (arm 4) will begin and participants will receive a dose determined during the dose escalation portion (part 1). Around 76 adult participants with relapsed/refractory AL amyloidosis will be enrolled at approximately 25 sites across the world. Participants will receive Etentamig (ABBV-383) as an infusion into the vein for up to approximately 2 year study duration. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and questionnaires.
This description comes directly from the study's public registry record.
ABBVIE CALL CENTER · 844-663-3742 · abbvieclinicaltrials@abbvie.com
Always discuss trial participation with your own doctor first.
| Sylvester Comprehensive Cancer Center - University of Miami /ID# 255856 | Miami, Florida, United States | Recruiting |
| Boston Medical Center /ID# 255066 | Boston, Massachusetts, United States | Recruiting |
| Mayo Clinic - Rochester /ID# 255258 | Rochester, Minnesota, United States | Recruiting |
| Icahn School of Medicine at Mount Sinai /ID# 255408 | New York, New York, United States | Recruiting |
| Columbia University Medical Center /ID# 255068 | New York, New York, United States | Recruiting |
| Memorial Sloan Kettering Cancer Center-Koch Center /ID# 255073 | New York, New York, United States | Recruiting |
| Atrium Health Levine Cancer Institute /ID# 255074 | Charlotte, North Carolina, United States | Recruiting |
| Atrium Health Wake Forest Baptist Medical Center /ID# 255851 | Winston-Salem, North Carolina, United States | Recruiting |
| Oregon Medical Research Center /ID# 255119 | Portland, Oregon, United States | Recruiting |
| Vanderbilt University Medical Center. /ID# 273510 | Nashville, Tennessee, United States | Recruiting |
| University of Washington /ID# 261581 | Seattle, Washington, United States | Recruiting |
| Wisconsin Medical Center /ID# 255836 | Milwaukee, Wisconsin, United States | Recruiting |
+ 11 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT06158854