Study ID:
M23-001ClinicalTrials.gov ID:
NCT06223516EudraCT ID:
Not AvailableEU CT ID:
2023-507901-32-00Multiple 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 det...
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Study Phase
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Healthy Volunteers
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Call us @: 844 663-3742
Location | Status | Site Contact Details |
---|---|---|
Location Mayo Clinic Arizona, Phoenix, Arizona, 85054 | Status Recruiting | Site Contact Details |
Location Mayo Clinic, Jacksonville, Florida, 32224 | Status Recruiting | Site Contact Details |
Location Sylvester Comprehensive Cancer Center, Miami, Florida, 33136-1002 | Status Recruiting | Site Contact Details |
Location University of Michigan Comprehensive Cancer Center Michigan Medicine, Ann Arbor, Michigan, 48109 | Status Recruiting | Site Contact Details |
Location Mayo Clinic - Rochester, Rochester, Minnesota, 55905-0001 | Status Recruiting | Site Contact Details |
Location Atrium Health Wake Forest Baptist Medical Center, Winston-Salem, North Carolina, 27157 | Status Recruiting | Site Contact Details |
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 ABBV-383 in adult participants with relapsed/refractory (R/R) MM. 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 25 sites across the world In Arm A participants will receive one of two doses of 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.
Percentage of Participants Experiencing Cytokine Release Syndrome (CRS) Events
Time Frame: Up to 2 cycles (56 days)
Percentage of Participants Experiencing Immune Cell-Associated Neurotoxicity Syndrome (ICANS) Events
Time Frame: Up to 2 cycles (56 days)
Maximum Observed Concentration (Cmax) of ABBV-383
Time Frame: Up to 32 weeks
Time to Cmax (Tmax) of ABBV-383
Time Frame: Up to 32 weeks
Trough Concentration (Ctrough) of ABBV-383
Time Frame: Up to 32 weeks
Area Under the Plasma Concentration-time Curve (AUC) of ABBV-383
Time Frame: Up to 24 weeks
Overall Response Rate (ORR)
Time Frame: Up to 24 months
Percentage of Participants Achieving Stringent Complete Response (sCR),
Time Frame: Up to 24 months
Percentage of Participants Achieving Complete Response (CR)
Time Frame: Up to 24 months
Percentage of Participants Achieving Very Good Partial Response (VGPR)
Time Frame: Up to 24 months
Percentage of Participants Achieving Partial Response (PR)
Time Frame: Up to 24 months
Duration of Response (DoR)
Time Frame: Up to 24 months
Progression Free Survival (PFS)
Time Frame: Up to 24 months
Time to Response (TTR)
Time Frame: Up to 24 months
Immunogenicity of ABBV-383 as Determined by Anti-Drug Antibodies (ADAs)
Time Frame: Up to 27 months
Immunogenicity of ABBV-383 as Determined by Neutralizing Anti-Drug Antibodies (NAbs)
Time Frame: Up to 27 months
Interventions:
Enrollment:
55
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