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

NCT06223516 | Active Not Recruiting Phase 1

• 2 other identifiers: M23-0012023-507901-32-00
• Study Type: interventional
• Target: 60
• Locations: 4 countries
• Sites: 15

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 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.

Conditions

Multiple Myeloma

Keywords

Multiple Myeloma; ABBV-383; Etentamig

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (10)

• Overall Response Rate (ORR)

  Up to 24 months

• Percentage of Participants Achieving Stringent Complete Response (sCR),

  Up to 24 months

• Percentage of Participants Achieving Complete Response (CR)

  Up to 24 months

• Percentage of Participants Achieving Very Good Partial Response (VGPR)

  Up to 24 months

• Percentage of Participants Achieving Partial Response (PR)

  Up to 24 months

Study Arms (3)

Etentamig Dose A

EXPERIMENTAL

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; Drug: Intravenous (IV) Etentamig

Etentamig Dose B

EXPERIMENTAL

Participants will receive Dose B of Etentamig as an SC injection and IV infusions, during the 151 week study duration.

Drug: Subcutaneous (SC) Etentamig; Drug: Intravenous (IV) Etentamig

Etentamig Expansion

EXPERIMENTAL

Participants will receive the selected dose from Arm A of Etentamig as SC injections, during the 151 week study duration.

Drug: Subcutaneous (SC) Etentamig

Interventions

Subcutaneous (SC) Etentamig DRUG

SC Injection

Etentamig Dose A; Etentamig Dose B; Etentamig Expansion

Intravenous (IV) Etentamig DRUG

IV Infusion

Etentamig Dose A; Etentamig Dose B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• AbbVie: lead

Study Sites (15)

Mayo Clinic Arizona /ID# 260799

Phoenix, Arizona, 85054, United States

Location

Mayo Clinic Hospital Jacksonville /ID# 262808

Jacksonville, Florida, 32224, United States

Location

Sylvester Comprehensive Cancer Center /ID# 260798

Miami, Florida, 33136-1002, United States

Location

University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 261050

Ann Arbor, Michigan, 48109, United States

Location

Mayo Clinic - Rochester /ID# 262807

Rochester, Minnesota, 55905-0001, United States

Location

Atrium Health Wake Forest Baptist Medical Center /ID# 260807

Winston-Salem, North Carolina, 27157, United States

Location

Wisconsin Medical Center /ID# 261085

Milwaukee, Wisconsin, 53226, United States

Location

Universitaetsklinikum Frankfurt /ID# 260442

Frankfurt am Main, Hesse, 60590, Germany

Location

Universitaetsklinikum Koeln /ID# 260445

Cologne, North Rhine-Westphalia, 50937, Germany

Location

Universitaetsklinikum Hamburg-Eppendorf /ID# 260444

Hamburg, 20246, Germany

Location

Hadassah Medical Center-Hebrew University /ID# 261446

Jerusalem, Jerusalem, 91120, Israel

Location

The Chaim Sheba Medical Center /ID# 261699

Ramat Gan, Tel Aviv, 5265601, Israel

Location

Tel Aviv Sourasky Medical Center /ID# 261525

Tel Aviv, Tel Aviv, 6423906, Israel

Location

Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital /ID# 265286

Nagoya, Aichi-ken, 466-8650, Japan

Location

Kindai University Hospital /ID# 266016

Sakai-shi, Osaka, 590-0197, Japan

Location

Related Links

• Related Info

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Injections, Subcutaneous

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Injections; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2024
• First Posted: January 25, 2024
• Study Start: June 17, 2024
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (7); DE (3); IL (3); JP (2)