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Multiple MyelomaPhase 1NCT06223516

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

A Phase 1 study testing Subcutaneous (SC) Etentamig and Intravenous (IV) Etentamig in people with Multiple Myeloma, run by AbbVie at 15 sites in 4 countries.

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 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Myeloma
What is being tested?
Subcutaneous (SC) Etentamig and Intravenous (IV) Etentamig
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
15 sitesin 4 countries
Study dates
17 Jun 2024to Dec 2027
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 18 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.
  • 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.

Who cannot join

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

Trial locations and contacts

15 sites in 4 countries.

15 sites in 4 countries

United States7 sites

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

    Ann Arbor, Michigan, 48109

  • Mayo Clinic Hospital Jacksonville /ID# 262808

    Jacksonville, Florida, 32224

  • Sylvester Comprehensive Cancer Center /ID# 260798

    Miami, Florida, 33136-1002

  • Wisconsin Medical Center /ID# 261085

    Milwaukee, Wisconsin, 53226

  • Mayo Clinic Arizona /ID# 260799

    Phoenix, Arizona, 85054

  • Mayo Clinic - Rochester /ID# 262807

    Rochester, Minnesota, 55905-0001

  • Atrium Health Wake Forest Baptist Medical Center /ID# 260807

    Winston-Salem, North Carolina, 27157

Other trials in United States

Germany3 sites

  • Universitaetsklinikum Koeln /ID# 260445

    Cologne, North Rhine-Westphalia, 50937

  • Universitaetsklinikum Frankfurt /ID# 260442

    Frankfurt am Main, Hesse, 60590

  • Universitaetsklinikum Hamburg-Eppendorf /ID# 260444

    Hamburg, 20246

Other trials in Germany

Israel3 sites

  • Hadassah Medical Center-Hebrew University /ID# 261446

    Jerusalem, Jerusalem, 91120

  • The Chaim Sheba Medical Center /ID# 261699

    Ramat Gan, Tel Aviv, 5265601

  • Tel Aviv Sourasky Medical Center /ID# 261525

    Tel Aviv, Tel Aviv, 6423906

Other trials in Israel

Japan2 sites

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

    Nagoya, Aichi-ken, 466-8650

  • Kindai University Hospital /ID# 266016

    Sakai-shi, Osaka, 590-0197

Other trials in Japan

About this study

Official title: 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

Read more

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.

Being tested
Subcutaneous (SC) Etentamig, Intravenous (IV) Etentamig
Keywords
Multiple Myeloma, ABBV-383, Etentamig
Medical subject headings
Multiple Myeloma

What participants receive

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

  • Subcutaneous (SC) EtentamigDrug

    SC Injection

  • Intravenous (IV) EtentamigDrug

    IV Infusion

Study groups in NCT06223516
Study groupRoleWhat they receive
Etentamig Dose AExperimentalParticipants will receive Dose A of Etentamig as a subcutaneous (SC) injection and intravenous (IV) infusions, during the 151 week study duration.
Receives: Drug: Subcutaneous (SC) Etentamig; Drug: Intravenous (IV) Etentamig
Etentamig Dose BExperimentalParticipants will receive Dose B of Etentamig as an SC injection and IV infusions, during the 151 week study duration.
Receives: Drug: Subcutaneous (SC) Etentamig; Drug: Intravenous (IV) Etentamig
Etentamig ExpansionExperimentalParticipants will receive the selected dose from Arm A of Etentamig as SC injections, during the 151 week study duration.
Receives: Drug: Subcutaneous (SC) Etentamig

What is being measured

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

  1. 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.

    Measured: Up to 2 cycles (56 days)

  2. 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.

    Measured: Up to 2 cycles (56 days)

  3. Maximum Observed Concentration (Cmax) of ABBV-383

    Cmax of ABBV-383.

    Measured: Up to 32 weeks

  4. Time to Cmax (Tmax) of ABBV-383

    Tmax of ABBV-383.

    Measured: Up to 32 weeks

  5. Trough Concentration (Ctrough) of ABBV-383

    Ctrough of ABBV-383.

    Measured: Up to 32 weeks

  6. Area Under the Plasma Concentration-time Curve (AUC) of ABBV-383

    AUC of ABBV-383.

    Measured: Up to 24 weeks

Secondary outcomes (10)

  1. 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.

    Measured: Up to 24 months

  2. 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.

    Measured: Up to 24 months

  3. 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.

    Measured: Up to 24 months

  4. 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.

    Measured: Up to 24 months

  5. 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.

    Measured: Up to 24 months

  6. 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.

    Measured: Up to 24 months

  7. 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.

    Measured: Up to 24 months

  8. 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.

    Measured: Up to 24 months

  9. Immunogenicity of ABBV-383 as Determined by Anti-Drug Antibodies (ADAs)

    Incidence and concentration of ADAs.

    Measured: Up to 27 months

  10. Immunogenicity of ABBV-383 as Determined by Neutralizing Anti-Drug Antibodies (NAbs)

    Incidence and concentration of NAbs.

    Measured: Up to 27 months

Timeline

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

  1. First posted25 Jan 2024
  2. Study start17 Jun 2024
  3. Primary completionFeb 2027 (estimated)
  4. Study completionDec 2027 (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
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06223516
Sponsor's protocol ID
M23-001
Other IDs
2023-507901-32-00, 2023
Status last verified
Mar 2026
First submitted
17 Jan 2024
Last updated
27 Mar 2026
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 Subcutaneous (SC) Etentamig and Intravenous (IV) Etentamig in people with Multiple Myeloma, run by AbbVie at 15 sites in 4 countries.

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 3 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 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in United States, Germany, Israel, 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?

Percentage of Participants Experiencing Cytokine Release Syndrome (CRS) Events (time frame: Up to 2 cycles (56 days)). The study lists 6 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 NCT06223516.

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 27 Mar 2026.

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