Multiple myeloma (MM) is a cancer of the blood's plasma cells. The cancer is typically found in the bones and bone marrow (the spongy tissue inside of the bones) and can cause bone pain, fractures, infections, weaker bones, and kidney failure. Treatments are available, but MM can come back (relapsed) or may not get better (refractory) with treatment. This is a study to determine the safety and pharmacokinetics of Etentamig (ABBV-383) in adult participants with relapsed/refractory (R/R) MM. Etentamig (ABBV-383) is an investigational drug being developed for the treatment of R/R MM. This study is broken into 3 Arms: Arm A with 2 parts and Arm B as an expansion. Participants will receive ABBV-383 as a subcutaneous (SC) injection and intravenous (IV) infusion in Arm A and SC injections of ABBV-383 in Arm B. Around 55 adult participants with relapsed/refractory multiple myeloma will be enrolled at approximately 15 sites across the world In Arm A participants will receive one of two doses of Etentamig (ABBV-383) as an SC injection and (IV) infusions, during the 151 week study duration. In Arm B, participants will receive the selected dose from Arm A as SC injections, during the 151 week 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
60
SC Injection
IV Infusion
Mayo Clinic Arizona /ID# 260799
Phoenix, Arizona, United States
Mayo Clinic Hospital Jacksonville /ID# 262808
Jacksonville, Florida, United States
Sylvester Comprehensive Cancer Center /ID# 260798
Miami, Florida, United States
University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 261050
Ann Arbor, Michigan, United States
Mayo Clinic - Rochester /ID# 262807
Rochester, Minnesota, United States
Atrium Health Wake Forest Baptist Medical Center /ID# 260807
Winston-Salem, North Carolina, United States
Wisconsin Medical Center /ID# 261085
Milwaukee, Wisconsin, United States
Universitaetsklinikum Frankfurt /ID# 260442
Frankfurt am Main, Hesse, Germany
Universitaetsklinikum Koeln /ID# 260445
Cologne, North Rhine-Westphalia, Germany
Universitaetsklinikum Hamburg-Eppendorf /ID# 260444
Hamburg, Germany
...and 5 more locations
Percentage of Participants Experiencing Cytokine Release Syndrome (CRS) Events
Cytokine Release Syndrome events will be graded using American Society for Transplantation and Cellular Therapy (ASTCT), with a higher grade indicating higher severity.
Time frame: Up to 2 cycles (56 days)
Percentage of Participants Experiencing Immune Cell-Associated Neurotoxicity Syndrome (ICANS) Events
ICANS events will be graded using ASTCT, with a higher grade indicating higher severity.
Time frame: Up to 2 cycles (56 days)
Maximum Observed Concentration (Cmax) of ABBV-383
Cmax of ABBV-383.
Time frame: Up to 32 weeks
Time to Cmax (Tmax) of ABBV-383
Tmax of ABBV-383.
Time frame: Up to 32 weeks
Trough Concentration (Ctrough) of ABBV-383
Ctrough of ABBV-383.
Time frame: Up to 32 weeks
Area Under the Plasma Concentration-time Curve (AUC) of ABBV-383
AUC of ABBV-383.
Time frame: Up to 24 weeks
Overall Response Rate (ORR)
The ORR is defined as the percentage of participants who achieve a best overall response of confirmed PR or better determined by international myeloma working group (IMWG) criteria, prior to the initiation of subsequent myeloma therapy.
Time frame: Up to 24 months
Percentage of Participants Achieving Stringent Complete Response (sCR),
sCR is defined as participants achieving negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, \< 5% plasma cells in bone marrow, normal free light chain (FLC) ratio, and Absence of clonal cells in bone marrow by immunohistochemistry.
Time frame: Up to 24 months
Percentage of Participants Achieving Complete Response (CR)
CR is defined as participants achieving negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, \< 5% plasma cells in bone marrow, and for participants in whom the only measurable disease is by serum FLC levels, a normal FLC ratio.
Time frame: Up to 24 months
Percentage of Participants Achieving Very Good Partial Response (VGPR)
VGPR is defined as participants achieving serum and urine M-protein detectable by immunofixation but not on electrophoresis, \>= 90% reduction in serum M-protein plus urine, and for participants in whom the only measurable disease is by serum FLC levels, \>= 90% decrease in the difference between involved and uninvolved FLC levels.
Time frame: Up to 24 months
Percentage of Participants Achieving Partial Response (PR)
PR is defined as participants achieving \>= 50% reduction of serum M-protein, reduction in 24-hour urinary M-protein by \>= 90% as noted in the protocol, \>= 50% reduction in the size of soft tissue plasmacytomas is also required, if present at baseline.
Time frame: Up to 24 months
Duration of Response (DoR)
DoR will be defined as the time from the date of first response \[partial response (PR) + VGPR + complete response (CR) + stringent complete response (sCR)\] to the earliest occurrence of progressive disease, or death, whatever occurs first.
Time frame: Up to 24 months
Progression Free Survival (PFS)
PFS is defined as the duration from the date of randomization to the date of confirmed disease progression (PD) per international myeloma working group (IMWG) criteria, or death, whichever occurs first.
Time frame: Up to 24 months
Time to Response (TTR)
TTR is defined as the number of months from the date of first dose to the date of best overall response of CR or PR ('responders') determined by IMWG criteria.
Time frame: Up to 24 months
Immunogenicity of ABBV-383 as Determined by Anti-Drug Antibodies (ADAs)
Incidence and concentration of ADAs.
Time frame: Up to 27 months
Immunogenicity of ABBV-383 as Determined by Neutralizing Anti-Drug Antibodies (NAbs)
Incidence and concentration of NAbs.
Time frame: Up to 27 months
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