A Study to Assess Adverse Events and Change in Disease State of Intravenously (IV) Infused Etentamig (ABBV-383) of Adult Participants With Relapsed or Refractory Multiple Myeloma in Japan

A Phase 1 Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Etentamig (ABBV-383) Monotherapy in Japanese Subjects With Relapsed or Refractory Multiple Myeloma (4L+ RRMM Monotherapy Study)

Multiple myeloma (MM) is an incurable disease characterized by the growth of monoclonal plasma cells in the bone marrow. The purpose of this study is to assess the adverse events and change in disease state of etentamig in adult participants with relapsed/refractory (R/R) multiple myeloma (MM). Adverse events and change in disease state will be assessed.

Etentamig (ABBV-383) is an investigational drug being developed for the treatment of R/R MM. Study doctors put the participants in groups called treatment arms. Two doses of ABBV-383 will be explored. Each treatment arm receives a different dose of ABBV-383 to determine a tolerable dose. Approximately 12 adult participants with R/R MM will be enrolled in the study in approximately 6 sites in Japan.

Participants will receive intravenous (IV) Etentamig (ABBV-383) at two increasing doses in 21-day cycles.

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 an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, and and monitoring of side effects.

Study Overview

• Status: Active, not recruiting
• Conditions: Relapsed/Refractory Multiple Myeloma
• Intervention / Treatment: Drug: Etentamig

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Chiba
    • Kashiwa-shi, Chiba, Japan, 277-8577
      • National Cancer Center Hospital East /ID# 240943
  • Hokkaido
    • Sapporo-shi, Hokkaido, Japan, 060-8648
      • Hokkaido University Hospital /ID# 242672
  • Ishikawa
    • Kanazawa-shi, Ishikawa, Japan, 920-8641
      • Kanazawa University Hospital /ID# 240948
  • Okayama
    • Okayama-shi, Okayama, Japan, 701-1192
      • Duplicate_Okayama Medical Center /ID# 240949
  • Osaka
    • Suita-shi, Osaka, Japan, 565-0871
      • The University of Osaka Hospital /ID# 242032
  • Yamagata
    • Yamagata-shi, Yamagata, Japan, 990-9585
      • Yamagata University Hospital /ID# 240945

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Eastern Cooperative Oncology Group (ECOG) performance of <= 2.
• Must have adequate bone marrow function as defined in the protocol.
• Must meet laboratory parameters as outlined in the protocol.

• Must have a confirmed diagnosis of relapsed/refractory (R/R) multiple myeloma (MM) with documented evidence of progression during or after the participant's last treatment regimen based on the investigator's determination of the International Myeloma Working group (IMWG) criteria.

  • Relapsed defined as previously treated myeloma that progresses and requires initiation of salvage therapy, but does not meet criteria for refractory myeloma.
  • Refractory defined as disease that is nonresponsive (failure to achieve minimal response or development of progressive disease) while on primary or salvage therapy, or progresses within 60 days of last therapy.
• Must have received at least 3 prior lines of therapy (including exposure to a proteasome inhibitor (PI), an immunomodulatory imide (IMiD), and an anti-CD38 mAb).

• Must have measurable disease within 28 days of enrollment, defined as at least 1 of the following:

  • Serum M-protein >= 0.5 g/dL (>= 5 g/L).
  • Urine M-protein >= 200 mg/24 hours.
  • Serum free light chain (FLC) >= 100 mg/L (involved light chain) and an abnormal serum kappa lambda ratio only for participants without measurable serum or urine M-protein.
• Consents to a fresh pretreatment bone marrow tumor biopsy or has adequate archival bone marrow tumor tissue that was collected within 12 weeks prior to screening and without intervening treatment.

Exclusion Criteria:

- Has received B-cell maturation antigen (BCMA)-targeted therapy. Participants who have received targeted therapy against non-BCMA targets will not be excluded.

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

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1 (Etentamig Dose A); Participants with relapsed or refractory (R/R) multiple myeloma (MM) who meet the criteria outline in the protocol will receive Etentamig Dose A in 21-day cycles.	Drug: Etentamig; Intravenous (IV) Infusion
Experimental: Cohort 2 (Etentamig Dose B); Participants with R/R MM who meet the criteria outline in the protocol will receive Etentamig Dose B in 21-day cycles.	Drug: Etentamig; Intravenous (IV) Infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Adverse Events (AE)	AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.	Up to Approximately 24 Months
Number of Dose-Limiting Toxicities (DLT)	DLT events are defined as adverse events or abnormal laboratory values assessed as "reasonable possibility" of relationship to the administration of Etentamig, which cannot be attributed by the investigator to a clearly identifiable cause such as disease progression or concurrent illness.	Up to Approximately 12 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate (ORR)	ORR is defined as the percentage of participants who achieve confirmed partial response (PR) or better determined by International Myeloma Working Group (IMWG) criteria, prior to the initiation of subsequent myeloma therapy.	Up to Approximately 24 Months
Progression Free Survival (PFS)	PFS is defined as the duration from the date of first dose to the date of disease progression (PD) determined by IMWG criteria, or death, whichever occurs first.	Up to Approximately 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 as assessed by investigator.	Up to Approximately 24 Months
Duration of Response (DOR)	DOR is defined as the number of days from the day the response criteria are met to the date that disease progression is objectively documented.	Up to Approximately 24 Months
Minimal Residual Disease (MRD) Negativity Rate	MRD is defined as the percentage of participants with assessment of the minimal residual disease negativity.	Up to Approximately 24 Months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): March 24, 2022
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: March 17, 2022
• First Submitted That Met QC Criteria: March 17, 2022
• First Posted (Actual): March 18, 2022

Study Record Updates

• Last Update Posted (Actual): August 8, 2025
• Last Update Submitted That Met QC Criteria: August 7, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Cancer; Relapsed/Refractory Multiple Myeloma; Etentamig
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Multiple Myeloma; Neoplasms, Plasma Cell
• Other Study ID Numbers: M22-984

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.: No