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Multiple MyelomaPhase 1NCT05650632

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

A Phase 1 study testing Etentamig (ABBV-383) in people with Multiple Myeloma, run by AbbVie at 46 sites in 7 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Multiple Myeloma (MM) is a cancer of the blood's plasma cells ( blood cell). 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?
Etentamig (ABBV-383)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
210 participants
Where
46 sitesin 7 countries
Study dates
21 Mar 2023to Aug 2029
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

  • Must have measurable disease as outlined in the protocol.
  • Eastern Cooperative Oncology Group (ECOG) performance of <= 2. Arm C and Arm D: ECOG performance of <= 1.
  • 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) 2016 criteria.
  • Must be naïve to treatment with etentamig (ABBV-383).
  • Arm A: Must have received at least 3 or more lines of therapy, including a proteasome inhibitor (PI), an immunomodulatory imide drug (IMiD), and an anti-CD38 monoclonal antibody.
  • Arm B: Must have received at least 2 or more lines of therapy, including exposure to a PI, an IMiD, an anti-CD38 monoclonal antibody, and a prior B-cell maturation antigen (BCMA)-targeted therapy (must be an anti-drug conjugate [ADC] or chimeric antigen receptor T-cell [CAR-T] directed against BCMA).
  • Arm C: Must have received at least 2 or more lines of therapy, including exposure to a PI, an IMiD, and an anti-CD38 monoclonal antibody. Must be suitable for outpatient administration of etentamig (ABBV-383).
  • Arm D: Must have received at least 1 and no more than 3 prior lines of therapy, including exposure to a PI, an IMiD, or an anti-CD38 monoclonal antibody. Must be suitable for outpatient administration of etentamig (ABBV-383).

Who cannot join

  • Arm A: Received BCMA-targeted therapy.
  • Arm C and Arm D: Rapidly progressing disease per investigator.

Trial locations and contacts

46 sites in 7 countries. Contact the study team or a site near you to ask about taking part.

ABBVIE CALL CENTER contact

844-663-3742

abbvieclinicaltrials@abbvie.com

46 sites in 7 countries

United States27 sites, 27 recruiting

  • Rocky Mountain Cancer Centers - Aurora /ID# 268574

    Aurora, Colorado, 80012

    Recruiting

  • Texas Oncology - Central/South Texas /ID# 268563

    Austin, Texas, 78705

    Recruiting

  • University of North Carolina /ID# 251203

    Chapel Hill, North Carolina, 27514

    Recruiting

  • University Of Cincinnati Medical Center /ID# 251746

    Cincinnati, Ohio, 45219

    Recruiting

  • Texas Oncology - Dallas - Worth Street /ID# 280064

    Dallas, Texas, 75246

    Recruiting

  • Willamette Valley Cancer Institute and Research Center /ID# 267088

    Eugene, Oregon, 97401

    Recruiting

  • Virginia Cancer Specialists - Fairfax /ID# 268559

    Fairfax, Virginia, 22031

    Recruiting

  • Fort Wayne Medical Oncology And Hematology /ID# 268179

    Fort Wayne, Indiana, 46804

    Recruiting

  • Hope And Healing Cancer Services /ID# 268536

    Hinsdale, Illinois, 60521

    Recruiting

  • Oncology Consultants /ID# 268323

    Houston, Texas, 77030

    Recruiting

  • Franciscan St. Francis Health /ID# 280928

    Indianapolis, Indiana, 46237

    Site Coordinator, 317-528-8538, kathleen.novak@franciscanalliance.org

    Recruiting

  • NHO Revive Research Institute, LLC /ID# 267869

    Lincoln, Nebraska, 68506

    Recruiting

  • Baptist Memorial Hospital /ID# 280677

    Memphis, Tennessee, 38120

    Not yet recruiting

  • Vanderbilt Ingram Cancer Center /ID# 252470

    Nashville, Tennessee, 37232-0021

    Recruiting

  • Tulane University School of Medicine /ID# 251204

    New Orleans, Louisiana, 70112

    Recruiting

  • Mt Sinai /ID# 251166

    New York, New York, 10029-6542

    Recruiting

  • Memorial Sloan Kettering Cancer Center-Koch Center /ID# 251167

    New York, New York, 10065-6007

    Recruiting

  • Medical Oncology Hematology Consultants /ID# 268560

    Newark, Delaware, 19713

    Recruiting

  • Nebraska Cancer Specialists - Omaha - Wright Street /ID# 282497

    Omaha, Nebraska, 68130

    Recruiting

  • Mayo Clinic Arizona /ID# 251405

    Phoenix, Arizona, 85054

    Recruiting

  • Mayo Clinic - Rochester /ID# 251164

    Rochester, Minnesota, 55905-0001

    Recruiting

  • Fred Hutchinson Cancer Center. /ID# 267940

    Seattle, Washington, 98109-4405

    Recruiting

  • Maryland Oncology Hematology - Silver Spring /ID# 268562

    Silver Spring, Maryland, 20904

    Not yet recruiting

  • Highlands Oncology Group - Springdale /ID# 267742

    Springdale, Arkansas, 72762

    Recruiting

  • Northwest Medical Specialties Tacoma /ID# 267117

    Tacoma, Washington, 98405

    Recruiting

  • Texas Oncology - Northeast Texas /ID# 268877

    Tyler, Texas, 75702

    Recruiting

  • Atrium Health Wake Forest Baptist Medical Center /ID# 251165

    Winston-Salem, North Carolina, 27157

    Recruiting

Other trials in United States

France6 sites, 3 recruiting

  • Hopitaux Universitaires Henri Mondor - Hopital Henri Mondor /ID# 252101

    Créteil, Paris, 94010

    Completed

  • Institut Paoli-Calmettes /ID# 252100

    Marseille, Bouches-du-Rhone, 13009

    Completed

  • Centre Hospitalier Universitaire de Nantes, Hotel Dieu -HME /ID# 251196

    Nantes, Pays de la Loire Region, 44000

    Recruiting

  • AP-HP - Hopital Saint-Antoine /ID# 252326

    Paris, 75012

    Completed

  • HCL - Hopital Lyon Sud /ID# 251223

    Pierre-Bénite, Rhone, 69495

    Recruiting

  • CHU Poitiers - La miletrie /ID# 251219

    Poitiers, Vienne, 86000

    Recruiting

Other trials in France

Israel4 sites, 4 recruiting

  • Hadassah Medical Center-Hebrew University /ID# 252079

    Jerusalem, Jerusalem, 91120

    Recruiting

  • Rabin Medical Center. /ID# 251330

    Petah Tikva, Central District, 4941492

    Recruiting

  • The Chaim Sheba Medical Center /ID# 251329

    Ramat Gan, Tel Aviv, 5265601

    Recruiting

  • Tel Aviv Sourasky Medical Center /ID# 251573

    Tel Aviv, Tel Aviv, 6423906

    Recruiting

Other trials in Israel

Spain3 sites, 2 recruiting

  • Hospital Universitario Puerta de Hierro - Majadahonda /ID# 251545

    Majadahonda, Madrid, 28222

    Completed

  • Hospital Universitario de Salamanca /ID# 251529

    Salamanca, 37711

    Recruiting

  • Hospital Universitario Marques de Valdecilla /ID# 251528

    Santander, Cantabria, 39008

    Recruiting

Other trials in Spain

Canada2 sites, 1 recruiting

  • Juravinski Cancer Centre /ID# 252053

    Hamilton, Ontario, L8V 1C3

    Recruiting

  • Ottawa Hospital Research Institute /ID# 252151

    Ottawa, Ontario, K1H 8L6

    Completed

Other trials in Canada

Denmark2 sites, 2 recruiting

  • Odense University Hospital /ID# 251261

    Odense, Region Syddanmark, 5000

    Recruiting

  • Vejle Sygehus /ID# 251260

    Vejle, Region Syddanmark, 7100

    Recruiting

Other trials in Denmark

United Kingdom2 sites, 2 recruiting

  • University College London Hospital /ID# 251357

    London, Greater London, NW1 2BU

    Recruiting

  • The Christie Hospital /ID# 251774

    Manchester, M20 4BX

    Site Coordinator, 0161 446 3285

    Recruiting

Other trials in United Kingdom

About this study

Official title: A Multicenter, Phase 1b, Open-label Study to Evaluate Dose Optimization Measures and Safety of Etentamig (ABBV-383) in Subjects With Relapsed or Refractory Multiple Myeloma

Multiple Myeloma (MM) is a cancer of the blood's plasma cells ( blood cell). 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 adverse events and change in disease symptoms 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 Multiple Myeloma (MM). This study is broken into 4 Arms; Arm A (Parts 1 and 2), Arm B and Arms C \& D. Arm A includes 2 parts: step-up dose optimization (Part 1) and dose expansion (Part 2). In Part 1, different level of step-up doses are tested followed by the target dose of etentamig (ABBV-383). In Part 2, the step-up dose identified in Part 1 (Dose A) will be used followed by the target dose A of etentamig (ABBV-383). In Arm B a flat dose of etentamig (ABBV-383) will be tested. In Arms C \& D, the step-up dose identified in Arm A will be used followed by the target dose of etentamig (ABBV-383) to investigate outpatient administration of etentamig (ABBV-383). Around 210 adult participants with relapsed/refractory multiple myeloma will be enrolled at approximately 50 sites across the world.

Read more

Participants will receive etentamig (ABBV-383) as an infusion into the vein in 28 day cycles for approximately 3 years.

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
Etentamig (ABBV-383)
Keywords
Multiple Myeloma, Cancer, ABBV-383, B-Cell Maturation Antigen
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.

  • Etentamig (ABBV-383)Drug

    Intravenous Infusion

Study groups in NCT05650632
Study groupRoleWhat they receive
Arm A (Part 1): ABBV-383 Dose EscalationExperimentalB-cell maturation antigen (BCMA) naïve participants will receive different doses of ABBV-383 in 28 day cycles.
Receives: Drug: Etentamig (ABBV-383)
Arm A (Part 2): ABBV-383 Dose ExpansionExperimentalBCMA naïve participants will receive the dose of ABBV-383 dose A in 28 day cycles.
Receives: Drug: Etentamig (ABBV-383)
Arm B: ABBV-383 BCMA ExposedExperimentalParticipants previously exposed to BCMA-targeted agents will receive ABBV-383 Dose A in 28 day cycles.
Receives: Drug: Etentamig (ABBV-383)
Arm C: ABBV-383 Step UpExperimentalParticipants will receive step up dose and full target dose of ABBV-383 in 28 day cycles.
Receives: Drug: Etentamig (ABBV-383)
Arm D: ABBV-383 Step UpExperimentalParticipants who have received at least 1 and no more than 3 prior lines of therapy will receive step up dose and full target dose of ABBV-383 in 28 day cycles.
Receives: Drug: Etentamig (ABBV-383)

What is being measured

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

  1. Arm A (Part 1 and Part 2) Arm C, and Arm D: Number of Grade >= 2 Cytokine Release Syndrome (CRS) Events

    CRS is defined by fever, hypoxia, and hypotension and graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) guidelines

    Measured: Up to Day 28

  2. Arm B: Number of Adverse Events (AEs) of Special Interest (CRS and Immune Effector Cell-associated Neurotoxicity Syndrome [ICANS])

    AEs of special interest will be graded according to American Society for Transplantation and Cellular Therapy (ASTCT) 2019 guidelines. All other AEs will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.

    Measured: Up to Day 28

Secondary outcomes (1)

  1. Arm A, Arm C. and Arm D: Number of Cytokine Release Syndrome (CRS) Events

    CRS is defined by fever, hypoxia, and hypotension and graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) guidelines

    Measured: Up to 3 Years

Timeline

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

  1. First posted14 Dec 2022
  2. Study start21 Mar 2023
  3. Primary completionAug 2029 (estimated)
  4. Study completionAug 2029 (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
210 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05650632
Sponsor's protocol ID
M24-108
Other IDs
2023-504674-38-00, 2023
Status last verified
Jul 2026
First submitted
6 Dec 2022
Last updated
13 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Etentamig (ABBV-383) in people with Multiple Myeloma, run by AbbVie at 46 sites in 7 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 8 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 46 sites in United States, France, Israel, Spain, Canada and 2 more countries. 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?

Contact ABBVIE CALL CENTER (844-663-3742, abbvieclinicaltrials@abbvie.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Arm A (Part 1 and Part 2) Arm C, and Arm D: Number of Grade >= 2 Cytokine Release Syndrome (CRS) Events (time frame: Up to Day 28). 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 NCT05650632.

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 13 Jul 2026.

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