Clinical Trial
Study Details
Study Overview
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.
Contacts and Locations
Sylvester Comprehensive Cancer Center - University of Miami /ID# 255856
Miami, Florida 33136
United States
Boston Medical Center /ID# 255066
Boston, Massachusetts 02118
United States
Mayo Clinic - Rochester /ID# 255258
Rochester, Minnesota 55905-0001
United States
Icahn School of Medicine at Mount Sinai /ID# 255408
New York, New York 10029
United States
Columbia University Medical Center /ID# 255068
New York, New York 10032-3729
United States
Memorial Sloan Kettering Cancer Center-Koch Center /ID# 255073
New York, New York 10065-6007
United States
Atrium Health Levine Cancer Institute /ID# 255074
Charlotte, North Carolina 28204
United States
Atrium Health Wake Forest Baptist Medical Center /ID# 255851
Winston-Salem, North Carolina 27157
United States
Oregon Medical Research Center /ID# 255119
Portland, Oregon 97239
United States
Vanderbilt University Medical Center. /ID# 273510
Nashville, Tennessee 37232
United States
University of Washington /ID# 261581
Seattle, Washington 98109
United States
Wisconsin Medical Center /ID# 255836
Milwaukee, Wisconsin 53226
United States
Westmead Hospital /ID# 255200
Westmead New South Wales 2145
Australia
Princess Alexandra Hospital /ID# 255202
Woolloongabba Queensland 4102
Australia
Box Hill Hospital /ID# 255199
Box Hill Victoria 3128
Australia
CHU Limoges - Dupuytren 1 /ID# 255370
87042 Limoges
France
CHU Toulouse - Hopital Rangueil /ID# 255377
31400 Toulouse
France
Alexandra General Hospital /ID# 255542
11528 Athens
Greece
IRCCS AOU di Bologna Policlinico Sant Orsola Malpighi /ID# 255654
40138 Bologna
Italy
Fondazione IRCCS Policlinico San Matteo /ID# 255655
27100 Pavia
Italy
Nagoya City University Hospital /ID# 256086
Nagoya, Aichi-ken
467-8602
Japan
Kumamoto University Hospital /ID# 262579
Kumamoto, Kumamoto
8608556
Japan
Study Contact
Japanese Red Cross Medical Center /ID# 256083
Shibuya-ku, Tokyo
150-8935
Japan