Study of ABBV-383 Assessing Adverse Events and Clinical Activity With Subcutaneous (SC) Injection in Adult Participants With Relapsed or Refractory Multiple Myeloma

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
AbbVie
Study ID
NCT06223516
Phase
PHASE1
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study 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 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.

Key Dates

Start date
Jun 17, 2024
Status verified
Mar 2026
Primary completion
Feb 28, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
60 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Etentamig Dose A
    Participants will receive Dose A of Etentamig as a subcutaneous (SC) injection and intravenous (IV) infusions, during the 151 week study duration.
  • Experimental: Etentamig Dose B
    Participants will receive Dose B of Etentamig as an SC injection and IV infusions, during the 151 week study duration.
  • Experimental: Etentamig Expansion
    Participants will receive the selected dose from Arm A of Etentamig as SC injections, during the 151 week study duration.

Primary Outcome Measure

Percentage of Participants Experiencing Cytokine Release Syndrome (CRS) Events [ Time Frame: Up to 2 cycles (56 days) ]

Locations (7)

FacilityCityStateZIPSite coordinators
Mayo Clinic Arizona /ID# 260799PhoenixArizona85054-
Mayo Clinic Hospital Jacksonville /ID# 262808JacksonvilleFlorida32224-
Sylvester Comprehensive Cancer Center /ID# 260798MiamiFlorida33136-1002-
University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 261050Ann ArborMichigan48109-
Mayo Clinic - Rochester /ID# 262807RochesterMinnesota55905-0001-
Atrium Health Wake Forest Baptist Medical Center /ID# 260807Winston-SalemNorth Carolina27157-
Wisconsin Medical Center /ID# 261085MilwaukeeWisconsin53226-

Find similar trials in Phoenix, AZ

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
Mayo Clinic Arizona· Phoenix, AZMayo Clinic Hospital Jacksonville· Jacksonville, FLSylvester Comprehensive Cancer Center· Miami, FLUniversity of Michigan Comprehensive Cancer Center Michigan Medicine· Ann Arbor, MIMayo Clinic - Rochester· Rochester, MNAtrium Health Wake Forest Baptist Medical Center· Winston-Salem, NC

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