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

NCT05286229 | Active Not Recruiting Phase 1

• 1 other identifier: M22-984
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Relapsed/Refractory Multiple Myeloma

Keywords

Relapsed/Refractory Multiple Myeloma; Etentamig; Cancer

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (5)

• Objective Response Rate (ORR)

  Up to Approximately 24 Months

• Progression Free Survival (PFS)

  Up to Approximately 24 Months

• Time to Response (TTR)

  Up to Approximately 24 Months

• Duration of Response (DOR)

  Up to Approximately 24 Months

• Minimal Residual Disease (MRD) Negativity Rate

  Up to Approximately 24 Months

Study Arms (2)

Cohort 1 (Etentamig Dose A)

EXPERIMENTAL

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

Cohort 2 (Etentamig Dose B)

EXPERIMENTAL

Participants with R/R MM who meet the criteria outline in the protocol will receive Etentamig Dose B in 21-day cycles.

Drug: Etentamig

Interventions

Etentamig DRUG

Intravenous (IV) Infusion

Cohort 1 (Etentamig Dose A); Cohort 2 (Etentamig Dose B)

Eligibility Criteria

• Age: 20 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.
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• AbbVie: lead

Study Sites (6)

National Cancer Center Hospital East /ID# 240943

Kashiwa-shi, Chiba, 277-8577, Japan

Location

Hokkaido University Hospital /ID# 242672

Sapporo, Hokkaido, 060-8648, Japan

Location

Kanazawa University Hospital /ID# 240948

Kanazawa, Ishikawa-ken, 920-8641, Japan

Location

Duplicate_Okayama Medical Center /ID# 240949

Okayama, Okayama-ken, 701-1192, Japan

Location

The University of Osaka Hospital /ID# 242032

Suita-shi, Osaka, 565-0871, Japan

Location

Yamagata University Hospital /ID# 240945

Yamagata, Yamagata, 990-9585, Japan

Location

MeSH Terms

Conditions

Multiple Myeloma; Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; 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

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: March 17, 2022
• First Posted: March 18, 2022
• Study Start: March 24, 2022
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: August 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

JP (6)