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Multiple MyelomaPhase 1NCT06896916

Study of Intravenously (IV) Infused Etentamig in Combination With an Oral Cereblon E3 Ligase Modulatory Drug (CELMoD) Agent Assessing Adverse Events and Change in Disease Activity in Adult Participants With Relapsed or Refractory Multiple Myeloma

A Phase 1 study testing Etentamig and Iberdomide in people with Multiple Myeloma, run by AbbVie at 27 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
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Trial summary

Multiple myeloma (MM) is a plasma cell disease characterized by the growth of clonal plasma cells in the bone marrow. The purpose of this study is to assess the adverse events and change in disease activity of etentamig in combination with a cereblon E3 ligase modulatory drug (CELMoD) agent in adult participants with… 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 and Iberdomide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
135 participants
Where
27 sitesin 7 countries
Study dates
7 Aug 2025to Mar 2036
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 0 or 1.
  • Must have confirmed diagnosis of Relapsed/Refractory Multiple Myeloma (RRMM) after the participant's last treatment, as outlined in the protocol.
  • All participants must have measurable diseases per central laboratory as outlined in protocol

Who cannot join

  • Has received prior etentamig treatment.
  • Prior exposure to BCMA-targeted therapy as noted in the protocol.
  • Has received prior cereblon E3 ligase modulatory drug (CELMoD) (iberdomide or mezigdomide).

Trial locations and contacts

27 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

27 sites in 7 countries

United States7 sites, 7 recruiting

  • Beverly Hills Cancer Center /ID# 266921

    Beverly Hills, California, 90211

    Recruiting

  • Colorado Blood Cancer Institute /ID# 273751

    Denver, Colorado, 80218

    Recruiting

  • University Of North Carolina Health Care - Hillsborough Campus /ID# 278230

    Hillsborough, North Carolina, 27278

    Recruiting

  • Rutgers Cancer Institute of New Jersey /ID# 266833

    New Brunswick, New Jersey, 08901

    Recruiting

  • Memorial Sloan Kettering Cancer Center - New York - York Avenue /ID# 270282

    New York, New York, 10065

    Recruiting

  • Swedish Medical Center - Seattle /ID# 268052

    Seattle, Washington, 98104

    Recruiting

  • Washington University /ID# 266972

    St Louis, Missouri, 63110

    Recruiting

Other trials in United States

Australia5 sites, 5 recruiting

  • Blacktown Hospital /ID# 265983

    Blacktown, New South Wales, 2148

    Recruiting

  • The Alfred Hospital /ID# 265981

    Melbourne, Victoria, 3004

    Recruiting

  • Austin Hospital /ID# 265984

    Melbourne, Victoria, 3084

    Recruiting

  • Sir Charles Gairdner Hospital /ID# 265985

    Nedlands, Western Australia, 6009

    Recruiting

  • Wollongong Hospital /ID# 265625

    Wollongong, New South Wales, 2500

    Recruiting

Other trials in Australia

France5 sites, 5 recruiting

  • Chu De Lille - Hopital Claude Huriez /ID# 270193

    Lille, Hauts-de-France, 59037

    Recruiting

  • Hôpital La Timone /ID# 267053

    Marseille, Bouches-du-Rhone, 13885

    Recruiting

  • Chu de Nice-Hopital Larchet Ii /Id# 266845

    Nice, Alpes-Maritimes, 06202

    Recruiting

  • IUCT Oncopole /ID# 266391

    Toulouse, Occitanie, 31059

    Site Coordinator, 05 31 15 50 50

    Recruiting

  • Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau /ID# 267694

    Tours, Indre-et-Loire, 37000

    Recruiting

Other trials in France

Japan5 sites, 5 recruiting

  • Nippon Medical School Hospital /ID# 270254

    Bunkyo-ku, Tokyo, 113-8603

    Recruiting

  • National Cancer Center Hospital East /ID# 268343

    Kashiwa-shi, Chiba, 277-8577

    Recruiting

  • The Cancer Institute Hospital Of JFCR /ID# 268342

    Koto-ku, Tokyo, 135-8550

    Recruiting

  • Kumamoto University Hospital /ID# 270530

    Kumamoto, Kumamoto, 860-8556

    Recruiting

  • Dokkyo Medical University Hospital /ID# 271648

    Mibu, Tochigi, 321-0293

    Recruiting

Other trials in Japan

Canada2 sites, 2 recruiting

  • Jewish General Hospital /ID# 267574

    Montreal, Quebec, H3T 1E2

    Recruiting

  • University Health Network_Princess Margaret Cancer Centre /ID# 275636

    Toronto, Ontario, M5G 2M9

    Recruiting

Other trials in Canada

Netherlands2 sites, 2 recruiting

  • Amsterdam UMC, Location VUmc /ID# 267670

    Amsterdam, North Holland, 1081 HV

    Recruiting

  • Universitair Medisch Centrum Utrecht /ID# 267660

    Utrecht, 3584 CX

    Recruiting

Other trials in Netherlands

Norway1 site, 1 recruiting

  • Oslo Universitetssykehus Ulleval /ID# 275433

    Oslo, 0450

    Recruiting

Other trials in Norway

About this study

Official title: Phase 1/2 Study of Etentamig in Combination With a CELMoD Agent for the Treatment of Patients With Relapsed/Refractory Multiple Myeloma

Multiple myeloma (MM) is a plasma cell disease characterized by the growth of clonal plasma cells in the bone marrow. The purpose of this study is to assess the adverse events and change in disease activity of etentamig in combination with a cereblon E3 ligase modulatory drug (CELMoD) agent in adult participants with relapsed/refractory (R/R) multiple myeloma (MM). Adverse events and change in disease state will be assessed.

Etentamig is an investigational drug being developed for the treatment of R/R MM. Study doctors put the participants in groups called treatment arms. Multiple doses of etentamig in combination with iberdomide will be explored. Each treatment arm receives a different dose of etentamig and iberdomide to determine a tolerable dose. Approximately 135 adult participants with R/R MM will be enrolled in the study in approximately 50 sites worldwide.

Read more

In phase 1 participants will receive escalating intravenous (IV) etentamig in combination with oral iberdomide. In phase 2 participants will receive IV etentamig at one of two doses in combination with oral iberdomide, as part of the approximately 129 month 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 an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and and monitoring of side effects.

Read the detailed description

B-cell maturation antigen (BCMA) chimeric antigen receptor T-cell (CAR-T) or BCMA antibody-drug conjugate (ADC) are allowed.

Being tested
Etentamig, Iberdomide
Keywords
Multiple Myeloma, Cereblon E3 Ligase Modulatory Drug, CELMoD, Iberdomide, Etentamig, ABBV-383
Medical subject headings
Multiple Myeloma

What participants receive

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

  • EtentamigDrug

    Intravenous (IV) Infusion

  • IberdomideDrug

    Oral Capsule

Study groups in NCT06896916
Study groupRoleWhat they receive
Phase 1: ABBV-383 Dose EscalationExperimentalIn phase 1 participants will receive escalating Etentamig in combination with iberdomide, as part of the approximately 129 month study duration.
Receives: Drug: Etentamig; Drug: Iberdomide
Phase 2: ABBV-383 Dose Expansion Dose AExperimentalIn phase 2 participants will receive Etentamig at dose A in combination with iberdomide, as part of the approximately 129 month study duration.
Receives: Drug: Etentamig; Drug: Iberdomide
Phase 2: ABBV-383 Dose Expansion Dose BExperimentalIn phase 2 participants will receive Etentamig at dose B in combination with iberdomide, as part of the approximately 129 month study duration.
Receives: Drug: Etentamig; Drug: Iberdomide

What is being measured

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

  1. Phase 1: Dose-Limiting Toxicities (DLT)s of Etentamig when given in Combination with Iberdomide in Participants with Relapsed/Refractory Multiple Myeloma (RRMM)

    DLT events are defined as clinically significant adverse events or abnormal laboratory values assessed as unrelated to disease progression, underlying disease, intercurrent illness, or concomitant medications.

    Measured: Up to Approximately 56 Days

  2. Number of Participants with Adverse Events (AE)s

    An adverse event 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 129 Months

Secondary outcomes (9)

  1. Partial Response (PR) Response Rate (RR)

    PR is defined >= 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by >= 90% or to < 200 mg per 24 hours, if the serum and urine M-protein are unmeasurable, a >= 50% decrease in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria, if the serum and urine M-protein are unmeasurable, and serum free light assay is also unmeasurable, a >= 50% reduction in plasma cells is required in place of M-protein, provided baseline bone marrow plasma cell percentage was >= 30%, >= 50% reduction in the size of soft tissue plasmacytomas is also required, if present at baseline.

    Measured: Up to 3 Years

  2. Very Good Partial Response (VGPR) RR

    VGPR is defined as serum and urine M-protein detectable by immunofixation but not on electrophoresis or >= 90% reduction in serum M-protein plus urine M-protein < 100 mg per 24 hours, for participants in whom the only measurable disease is by serum free light chains (FLC) levels, VGPR is defined as >= 90% decrease in the difference between involved and uninvolved FLC levels.

    Measured: Up to 3 Years

  3. Complete Response (CR) RR

    CR is defined negative immunofixation on the serum and urine (regardless of whether disease at baseline was measurable on serum, urine, both, or neither), 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 is also required.

    Measured: Up to 3 Years

  4. Stringent Complete Response (sCR) RR

    sCR is defined negative immunofixation on the serum and urine (regardless of whether disease at baseline was measurable on serum, urine, both, or neither), disappearance of any soft tissue plasmacytomas, < 5% plasma cells in bone marrow, normal FLC ratio and absence of clonal cells in bone marrow by immunohistochemistry (kappa/lambda ratio <= 4:1 or >= 1:2 for kappa and lambda participants, respectively, after counting >= 100 plasma cells).

    Measured: Up to 3 Years

  5. Overall Response Rate (ORR)

    ORR (PR + VGPR + CR + sCR) will be defined as the proportion of participants who achieved a PR or better.

    Measured: Up to 3 Years

  6. Progression-Free Survival (PFS)

    PFS is defined as the number of days from the date of first dose to the date of earliest disease progression or death.

    Measured: Up to 3 Years

  7. Duration of Response (DOR)

    DOR is defined as the number of days from the date of first response (sCR, CR, VGPR, or PR) to the earliest recurrence, progressive disease, or death, whatever occurs first.

    Measured: Up to 3 Years

  8. Time-to-Progression (TTP)

    TTP will be defined as the number of days from the date of first dose to the date of earliest disease progression.

    Measured: Up to 3 Years

  9. Minimal Residual Disease (MRD) negativity

    The MRD negativity rate is defined as the proportion of participants who achieve MRD negative status.

    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 posted26 Mar 2025
  2. Study start7 Aug 2025
  3. Primary completionMar 2036 (estimated)
  4. Study completionMar 2036 (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
135 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06896916
Sponsor's protocol ID
M24-555
Other IDs
2024-512146-41-00
Status last verified
May 2026
First submitted
19 Mar 2025
Last updated
12 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Etentamig and Iberdomide in people with Multiple Myeloma, run by AbbVie at 27 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 3 inclusion and 3 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 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in United States, Australia, France, Japan, 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?

Phase 1: Dose-Limiting Toxicities (DLT)s of Etentamig when given in Combination with Iberdomide in Participants with Relapsed/Refractory Multiple Myeloma (RRMM) (time frame: Up to Approximately 56 Days). 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 NCT06896916.

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 12 May 2026.

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