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Relapsed/Refractory Multiple MyelomaPhase 1NCT05286229

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 testing Etentamig in people with Relapsed/Refractory Multiple Myeloma, run by AbbVie at 6 sites in Japan.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Relapsed/Refractory Multiple Myeloma
What is being tested?
Etentamig
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
6 sitesJapan
Study dates
24 Mar 2022to Mar 2026
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

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

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Japan6 sites

  • Kanazawa University Hospital /ID# 240948

    Kanazawa, Ishikawa-ken, 920-8641

  • National Cancer Center Hospital East /ID# 240943

    Kashiwa-shi, Chiba, 277-8577

  • Duplicate_Okayama Medical Center /ID# 240949

    Okayama, Okayama-ken, 701-1192

  • Hokkaido University Hospital /ID# 242672

    Sapporo, Hokkaido, 060-8648

  • The University of Osaka Hospital /ID# 242032

    Suita-shi, Osaka, 565-0871

  • Yamagata University Hospital /ID# 240945

    Yamagata, Yamagata, 990-9585

Other trials in Japan

About this study

Official title: 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.

Read more

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.

Being tested
Etentamig
Keywords
Relapsed/Refractory Multiple Myeloma, Etentamig, Cancer
Medical subject headings
Multiple Myeloma, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EtentamigDrug

    Intravenous (IV) Infusion

Study groups in NCT05286229
Study groupRoleWhat they receive
Cohort 1 (Etentamig Dose A)ExperimentalParticipants 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.
Receives: Drug: Etentamig
Cohort 2 (Etentamig Dose B)ExperimentalParticipants with R/R MM who meet the criteria outline in the protocol will receive Etentamig Dose B in 21-day cycles.
Receives: Drug: Etentamig

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to Approximately 12 Months

  2. 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.

    Measured: Up to Approximately 24 Months

Secondary outcomes (5)

  1. 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.

    Measured: Up to Approximately 24 Months

  2. 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.

    Measured: Up to Approximately 24 Months

  3. 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.

    Measured: Up to Approximately 24 Months

  4. 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.

    Measured: Up to Approximately 24 Months

  5. Minimal Residual Disease (MRD) Negativity Rate

    MRD is defined as the percentage of participants with assessment of the minimal residual disease negativity.

    Measured: Up to Approximately 24 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Mar 2022
  2. Study start24 Mar 2022
  3. Primary completionMar 2026 (estimated)
  4. Study completionMar 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05286229
Sponsor's protocol ID
M22-984
Status last verified
Aug 2025
First submitted
17 Mar 2022
Last updated
8 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Etentamig in people with Relapsed/Refractory Multiple Myeloma, run by AbbVie at 6 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Dose-Limiting Toxicities (DLT) (time frame: Up to Approximately 12 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05286229.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2025; AzTrials last refreshed its copy on 6 Nov 2026.

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