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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
76
Intravenous Infusion
Sylvester Comprehensive Cancer Center - University of Miami /ID# 255856
Miami, Florida, United States
RECRUITINGBoston Medical Center /ID# 255066
Boston, Massachusetts, United States
RECRUITINGMayo Clinic - Rochester /ID# 255258
Rochester, Minnesota, United States
RECRUITINGIcahn School of Medicine at Mount Sinai /ID# 255408
New York, New York, United States
RECRUITINGColumbia University Medical Center /ID# 255068
New York, New York, United States
RECRUITINGMemorial Sloan Kettering Cancer Center-Koch Center /ID# 255073
New York, New York, United States
RECRUITINGAtrium Health Levine Cancer Institute /ID# 255074
Charlotte, North Carolina, United States
RECRUITINGAtrium Health Wake Forest Baptist Medical Center /ID# 255851
Winston-Salem, North Carolina, United States
RECRUITINGOregon Medical Research Center /ID# 255119
Portland, Oregon, United States
RECRUITINGUniversity of Washington /ID# 261581
Seattle, Washington, United States
RECRUITING...and 11 more locations
Dose Escalation Only: Number of Participants with Dose-Limiting Toxicities (DLT)
DLT events are defined as clinically significant adverse events or abnormal laboratory values assessed as unrelated to disease progression, underlying disease, intercurrent illness, or concomitant medications.
Time frame: Up to 28 Days
Dose Expansion Only: Percentage of Participants who Achieve Hematologic Complete Response (CR)
Hematologic CR is defined as the percentage of participants who achieve normalization of free light chain levels, negative serum immunofixation, negative urine immunofixation as determined per the modified International Amyloidosis Consensus Criteria (IACC).
Time frame: Up to 4 years
Dose Expansion Only: Number of Participants with DLTs
DLT events are defined as clinically significant adverse events or abnormal laboratory values assessed as unrelated to disease progression, underlying disease, intercurrent illness, or concomitant medications.
Time frame: Up to 4 years
Number of Participants with Adverse Events (AEs)
An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Time frame: Up to 4 years
Hematologic Overall Response Rate (ORR)
Hematologic ORR is defined as partial response (PR) + very good partial response (VGPR) + complete remission (CR), proportion of participants who achieved a PR or better, per the modified IACC.
Time frame: Up to 4 Years
Time to Hematologic CR
Time to hematologic CR is defined as the time from first dose of study drug until CR, per the modified IACC.
Time frame: Up to 4 Years
Duration of Hematologic CR
Duration of hematologic CR is defined as the time from CR until disease progression, per the modified IACC.
Time frame: Up to 4 Years
Organ Response Rate (OrRR)
Organ response rate is defined as the time from first dose of study drug until to response in the heart kidney and liver, per the IACC.
Time frame: Up to 4 Years
Time to Organ Response
Time to organ response is defined as the time from first dose of study drug until organ response, per the IACC.
Time frame: Up to 4 Years
Dose Escalation Only: Percentage of Participants who Achieve Hematologic CR Rate as Determined
Hematologic CR is defined as the percentage of participants who achieve normalization of free light chain levels, negative serum immunofixation, negative urine immunofixation as determined per the modified International Amyloidosis Consensus Criteria (IACC).
Time frame: Up to 4 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.