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

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

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 Overview

• Status: Active, not recruiting
• Conditions: Multiple Myeloma
• Intervention / Treatment: Drug: Subcutaneous (SC) Etentamig; Drug: Intravenous (IV) Etentamig

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Hamburg, Germany, 20246
    • Universitaetsklinikum Hamburg-Eppendorf /ID# 260444
  • Hesse
    • Frankfurt am Main, Hesse, Germany, 60590
      • Universitaetsklinikum Frankfurt /ID# 260442
  • North Rhine-Westphalia
    • Cologne, North Rhine-Westphalia, Germany, 50937
      • Universitaetsklinikum Koeln /ID# 260445
• Israel
  • Jerusalem
    • Jerusalem, Jerusalem, Israel, 91120
      • Hadassah Medical Center-Hebrew University /ID# 261446
  • Tel Aviv
    • Ramat Gan, Tel Aviv, Israel, 5265601
      • The Chaim Sheba Medical Center /ID# 261699
    • Tel Aviv, Tel Aviv, Israel, 6423906
      • Tel Aviv Sourasky Medical Center /ID# 261525
• Japan
  • Aichi-ken
    • Nagoya, Aichi-ken, Japan, 466-8650
      • Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital /ID# 265286
  • Osaka
    • Sakai-shi, Osaka, Japan, 590-0197
      • Kindai University Hospital /ID# 266016
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85054
      • Mayo Clinic Arizona /ID# 260799
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic Hospital Jacksonville /ID# 262808
    • Miami, Florida, United States, 33136-1002
      • Sylvester Comprehensive Cancer Center /ID# 260798
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 261050
  • Minnesota
    • Rochester, Minnesota, United States, 55905-0001
      • Mayo Clinic - Rochester /ID# 262807
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Atrium Health Wake Forest Baptist Medical Center /ID# 260807
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Wisconsin Medical Center /ID# 261085

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: Subcutaneous (SC) Etentamig; SC Injection; Drug: Intravenous (IV) Etentamig; IV Infusion
Experimental: Etentamig Dose B; Participants will receive Dose B of Etentamig as an SC injection and IV infusions, during the 151 week study duration.	Drug: Subcutaneous (SC) Etentamig; SC Injection; Drug: Intravenous (IV) Etentamig; IV Infusion
Experimental: Etentamig Expansion; Participants will receive the selected dose from Arm A of Etentamig as SC injections, during the 151 week study duration.	Drug: Subcutaneous (SC) Etentamig; SC Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Up to 2 cycles (56 days)
Maximum Observed Concentration (Cmax) of ABBV-383	Cmax of ABBV-383.	Up to 32 weeks
Time to Cmax (Tmax) of ABBV-383	Tmax of ABBV-383.	Up to 32 weeks
Trough Concentration (Ctrough) of ABBV-383	Ctrough of ABBV-383.	Up to 32 weeks
Area Under the Plasma Concentration-time Curve (AUC) of ABBV-383	AUC of ABBV-383.	Up to 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	Up to 24 months
Immunogenicity of ABBV-383 as Determined by Anti-Drug Antibodies (ADAs)	Incidence and concentration of ADAs.	Up to 27 months
Immunogenicity of ABBV-383 as Determined by Neutralizing Anti-Drug Antibodies (NAbs)	Incidence and concentration of NAbs.	Up to 27 months

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): June 17, 2024
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: January 17, 2024
• First Submitted That Met QC Criteria: January 17, 2024
• First Posted (Actual): January 25, 2024

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 26, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Multiple Myeloma; ABBV-383; Etentamig
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Neoplasms, Plasma Cell; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Hemic and Lymphatic Diseases; Multiple Myeloma; Therapeutics; Drug Administration Routes; Drug Therapy; Injections; Injections, Subcutaneous
• Other Study ID Numbers: M23-001; 2023-507901-32-00 (Other Identifier: EU CT)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes