Clinical trial NCT06223516: Study of ABBV-383 Assessing Adverse Events and Clinical Activity With Subcutaneous (SC) Injection in Adult Participants With Relapsed or Refractory Multiple Myeloma
Official title: A Multicenter, Phase 1b, Open-label Study of ABBV-383 Administered Subcutaneously in Subjects With Relapsed or Refractory Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Multiple Myeloma
Keywords: Multiple Myeloma
ABBV-383
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2024-01-25
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief 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 criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

- Received B-cell maturation antigen (BCMA)xCD3 bispecific antibody.

Primary outcomes:
measure: Percentage of Participants Experiencing Cytokine Release Syndrome (CRS) Events
timeFrame: Up to 2 cycles (56 days)
measure: Percentage of Participants Experiencing Immune Cell-Associated Neurotoxicity Syndrome (ICANS) Events
timeFrame: Up to 2 cycles (56 days)
measure: Maximum Observed Concentration (Cmax) of ABBV-383
timeFrame: Up to 32 weeks
measure: Time to Cmax (Tmax) of ABBV-383
timeFrame: Up to 32 weeks
measure: Trough Concentration (Ctrough) of ABBV-383
timeFrame: Up to 32 weeks
measure: Area Under the Plasma Concentration-time Curve (AUC) of ABBV-383
timeFrame: Up to 24 weeks
Secondary outcomes:
measure: Overall Response Rate (ORR)
timeFrame: Up to 24 months
measure: Percentage of Participants Achieving Stringent Complete Response (sCR),
timeFrame: Up to 24 months
measure: Percentage of Participants Achieving Complete Response (CR)
timeFrame: Up to 24 months
measure: Percentage of Participants Achieving Very Good Partial Response (VGPR)
timeFrame: Up to 24 months
measure: Percentage of Participants Achieving Partial Response (PR)
timeFrame: Up to 24 months
measure: Duration of Response (DoR)
timeFrame: Up to 24 months
measure: Progression Free Survival (PFS)
timeFrame: Up to 24 months
measure: Time to Response (TTR)
timeFrame: Up to 24 months
measure: Immunogenicity of ABBV-383 as Determined by Anti-Drug Antibodies (ADAs)
timeFrame: Up to 27 months
measure: Immunogenicity of ABBV-383 as Determined by Neutralizing Anti-Drug Antibodies (NAbs)
timeFrame: Up to 27 months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic Arizona /ID# 260799
state: Arizona
city: Jacksonville
country: United States
facility: Mayo Clinic /ID# 262808
state: Florida
city: Miami
country: United States
facility: Sylvester Comprehensive Cancer Center /ID# 260798
state: Florida
city: Ann Arbor
country: United States
facility: University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 261050
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic - Rochester /ID# 262807
state: Minnesota
city: Winston-Salem
country: United States
facility: Atrium Health Wake Forest Baptist Medical Center /ID# 260807
state: North Carolina
city: Milwaukee
country: United States
facility: Wisconsin Medical Center /ID# 261085
state: Wisconsin
city: Frankfurt am Main
country: Germany
facility: Universitaetsklinikum Frankfurt /ID# 260442
state: Hessen
city: Köln
country: Germany
facility: Universitaetsklinikum Koeln /ID# 260445
state: Nordrhein-Westfalen
city: Hamburg
country: Germany
facility: Universitaetsklinikum Hamburg-Eppendorf /ID# 260444
city: Ramat Gan
country: Israel
facility: The Chaim Sheba Medical Center /ID# 261699
state: Tel-Aviv
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center /ID# 261525
state: Tel-Aviv
city: Jerusalem
country: Israel
facility: Hadassah Medical Center-Hebrew University /ID# 261446
state: Yerushalayim
city: Nagoya
country: Japan
facility: Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital /ID# 265286
state: Aichi
city: Osakasayama-shi
country: Japan
facility: Kindai University Hospital /ID# 266016
state: Osaka
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: