A Multicenter, Phase 1b, Open-label Study of ABBV-383 Administered Subcutaneously in Subjects With Relapsed or Refractory Multiple Myeloma

Status: Recruiting
Location: See all (15) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Eastern Cooperative Oncology Group (ECOG) performance of \<= 2.

• Participants with relapsed or refractory multiple myeloma who have received 3-5 prior lines of therapies and with prior triple class exposure including a proteasome inhibitor, anti-CD38 monoclonal antibody and an immunomodulatory drug.

• Must be naïve to treatment with ABBV-383.

Locations
United States
Arizona
Mayo Clinic Arizona /ID# 260799
RECRUITING
Phoenix
Florida
Mayo Clinic /ID# 262808
RECRUITING
Jacksonville
Sylvester Comprehensive Cancer Center /ID# 260798
RECRUITING
Miami
Michigan
University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 261050
RECRUITING
Ann Arbor
Minnesota
Mayo Clinic - Rochester /ID# 262807
RECRUITING
Rochester
North Carolina
Atrium Health Wake Forest Baptist Medical Center /ID# 260807
RECRUITING
Winston-salem
Wisconsin
Wisconsin Medical Center /ID# 261085
COMPLETED
Milwaukee
Other Locations
Germany
Universitaetsklinikum Koeln /ID# 260445
RECRUITING
Cologne
Universitaetsklinikum Frankfurt /ID# 260442
RECRUITING
Frankfurt Am Main
Universitaetsklinikum Hamburg-Eppendorf /ID# 260444
RECRUITING
Hamburg
Israel
Hadassah Medical Center-Hebrew University /ID# 261446
RECRUITING
Jerusalem
The Chaim Sheba Medical Center /ID# 261699
RECRUITING
Ramat Gan
Tel Aviv Sourasky Medical Center /ID# 261525
RECRUITING
Tel Aviv
Japan
Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital /ID# 265286
RECRUITING
Nagoya
Kindai University Hospital /ID# 266016
RECRUITING
Osaka Sayama-shi
Contact Information
Primary
ABBVIE CALL CENTER
abbvieclinicaltrials@abbvie.com
844-663-3742
Time Frame
Start Date: 2024-06-17
Estimated Completion Date: 2027-02
Participants
Target number of participants: 55
Treatments
Experimental: ABBV-383 Dose A
Participants will receive Dose A of ABBV-383 as a subcutaneous (SC) injection and intravenous (IV) infusions, during the 151 week study duration.
Experimental: ABBV-383 Dose B
Participants will receive Dose B of ABBV-383 as an SC injection and IV infusions, during the 151 week study duration.
Experimental: ABBV-383 Expansion
Participants will receive the selected dose from Arm A of ABBV-383 as SC injections, during the 151 week study duration.
Related Therapeutic Areas
Sponsors
Leads: AbbVie

This content was sourced from clinicaltrials.gov

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