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Relapsed/Refractory Multiple MyelomaPhase 1NCT05259839

A Study to Assess Adverse Events and Change in Disease Activity of Intravenously (IV) Infused Etentamig (ABBV-383) in Combination With Anti-Cancer Regimens for the Treatment of Adult Participants With Relapsed/Refractory Multiple Myeloma

A Phase 1 study testing Etentamig, Dexamethasone and Lenalidomide in people with Relapsed/Refractory Multiple Myeloma, run by AbbVie at 49 sites in 7 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 plasma cell disease characterized by the growth of clonal plasma cells in the bone marrow. The purpose of this study is to assess the safety and toxicity of etentamig (ABBV-383) when co-administered with pomalidomide-dexamethasone (Pd), lenalidomide-dexamethasone (Rd), or… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Relapsed/Refractory Multiple Myeloma
What is being tested?
Etentamig, Dexamethasone and Lenalidomide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
283 participants
Where
49 sitesin 7 countries
Study dates
20 Oct 2022to Sep 2033
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.
  • Must have 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.
  • Must have measurable disease as determined by central lab as outlined in the protocol.
  • Must be naïve to treatment with Etentamig.
  • Must have never received BCMA-targeted therapy. Participants who have received targeted therapy against non-BCMA targets will not be excluded.
  • Arms A, B and C: Participant has received at least 3 prior lines of MM treatment.
  • Arm E: Participant has received 1-3 prior lines of MM treatment.

Who cannot join

  • Received a peripheral autologous stem cell transplant (SCT) within 12 weeks, or an allogeneic SCT within 1 year of the first dose of study treatment.
  • Unresolved adverse event (AE)s >= Grade 2 (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version 5.0) from prior anticancer therapy.
  • Has any of the following conditions:
  • Nonsecretory Multiple Myeloma (MM).
  • Active Plasma cell leukemia i.e., either 20% of peripheral white blood cells or > 2.0 × 10^9L circulating plasma cells by standard differential.
  • Waldenstrom's macroglobulinemia.
Show all 12Show fewer
  • Light chain amyloidosis.
  • Polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes (POEMS) syndrome.
  • Major surgery within 4 weeks prior to first dose or planned study participation.
  • Acute infections within 14 days prior to first dose of study requiring therapy (antibiotic, antifungal or antiviral).
  • Uncontrolled diabetes or hypertension within 14 days prior to first dose.
  • Peripheral neuropathy >= Grade 3 or >= Grade 2 with pain within 2 weeks prior to first dose.

Trial locations and contacts

49 sites in 7 countries.

49 sites in 7 countries

United States15 sites

  • University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 243438

    Ann Arbor, Michigan, 48109

  • University of Maryland, Baltimore /ID# 243679

    Baltimore, Maryland, 21201

  • Dana-Farber Cancer Institute /ID# 249529

    Boston, Massachusetts, 02215

  • Atrium Health Levine Cancer Institute /ID# 242851

    Charlotte, North Carolina, 28204

  • University of Texas - Southwestern Medical Center /ID# 243273

    Dallas, Texas, 75235

  • University of Arkansas for Medical Sciences /ID# 243096

    Little Rock, Arkansas, 72205

  • Sylvester Comprehensive Cancer Center /ID# 243673

    Miami, Florida, 33136-1002

  • Froedtert Memorial Lutheran Hospital /ID# 242654

    Milwaukee, Wisconsin, 53226-3522

  • Rutenberg Cancer Center /ID# 244647

    New York, New York, 10029-6030

  • Memorial Sloan Kettering Cancer Center /ID# 244656

    New York, New York, 10065-6007

  • The Valley Hospital /ID# 243829

    Paramus, New Jersey, 07652

  • Huntsman Cancer Institute /ID# 242872

    Salt Lake City, Utah, 84112-5500

  • University of Washington /ID# 243172

    Seattle, Washington, 98109

  • Moffitt Cancer Center /ID# 243437

    Tampa, Florida, 33612-9416

  • University of Massachusetts - Worcester /ID# 243977

    Worcester, Massachusetts, 01655

Other trials in United States

Australia7 sites

  • Monash Health - Monash Medical Centre - Clayton /ID# 244403

    Clayton, Victoria, 3168

  • St Vincent's Hospital Melbourne /ID# 256879

    Fitzroy Melbourne, Victoria, 3065

  • St George Hospital - Kogarah /ID# 243740

    Kogarah, New South Wales, 2217

  • Peter MacCallum Cancer Ctr /ID# 256880

    Melbourne, Victoria, 3000

  • Fiona Stanley Hospital /ID# 244753

    Murdoch, Western Australia, 6150

  • Epworth Healthcare /ID# 243734

    Richmond, Victoria, 3121

  • Calvary Mater Newcastle /ID# 243730

    Waratah, New South Wales, 2298

Other trials in Australia

Spain7 sites

  • Hospital Universitario Vall de Hebron /ID# 242976

    Barcelona, 08035

  • Hospital Clinic de Barcelona /ID# 242978

    Barcelona, 08036

  • Hospital Duran i Reynals /ID# 242979

    L'Hospitalet de Llobregat, Barcelona, 08907

  • CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 244145

    Madrid, 28027

  • Hospital Universitario 12 de Octubre /ID# 242975

    Madrid, 28041

  • Clinica Universidad de Navarra - Pamplona /ID# 242977

    Pamplona, Navarre, 31008

  • Hospital Universitario Virgen del Rocio /ID# 242974

    Seville, 41013

Other trials in Spain

Japan6 sites

  • Kanazawa University Hospital /ID# 246812

    Kanazawa, Ishikawa-ken, 920-8641

  • National Cancer Center Hospital East /ID# 245889

    Kashiwa-shi, Chiba, 277-8577

  • Nagoya City University Hospital /ID# 249094

    Nagoya, Aichi-ken, 467-8602

  • Okayama Medical Center /ID# 245882

    Okayama, Okayama-ken, 701-1192

  • Hokkaido University Hospital /ID# 245966

    Sapporo, Hokkaido, 060-8648

  • Yamagata University Hospital /ID# 245888

    Yamagata, Yamagata, 990-9585

Other trials in Japan

Germany5 sites

  • Universitaetsklinikum Essen /ID# 242819

    Essen, 45147

  • Universitaetsklinikum Hamburg-Eppendorf /ID# 243141

    Hamburg, 20246

  • Universitaetsklinikum Regensburg /ID# 242837

    Regensburg, Bavaria, 93042

  • Universitaetsklinikum Tuebingen /ID# 242815

    Tübingen, Baden-Wurttemberg, 72076

  • Universitaetsklinikum Wuerzburg /ID# 242826

    Würzburg, Bavaria, 97080

Other trials in Germany

Italy5 sites

  • IRCCS AOU di Bologna Policlinico Sant Orsola Malpighi /ID# 242581

    Bologna, 40138

  • Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST - IRCCS /ID# 242584

    Meldola, Forlì-Cesena, 47014

  • IRCCS Ospedale San Raffaele /ID# 242583

    Milan, Milano, 20132

  • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 244057

    Milan, 20122

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Universita Cattolica /ID# 242582

    Rome, Roma, 00168

Other trials in Italy

Poland4 sites

  • Uniwersyteckie Centrum Kliniczne /ID# 243249

    Gdansk, Pomeranian Voivodeship, 80-214

  • Uniwersytecki Szpital Kliniczny Nr 1 w Lublinie /ID# 243500

    Lublin, Lublin Voivodeship, 20-081

  • Szpital Wojewodzki w Opolu sp. z o.o. /ID# 243954

    Opole, Lower Silesian Voivodeship, 45-372

  • Uniwersytecki Szpital Kliniczny We Wroclawiu /ID# 243246

    Wroclaw, Lower Silesian Voivodeship, 50-556

Other trials in Poland

About this study

Official title: A Dose Escalation and Expansion Study of Etentamig (ABBV-383) in Combination With Anti-Cancer Regimens for the Treatment of Patients With Newly Diagnosed or 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 safety and toxicity of etentamig (ABBV-383) when co-administered with pomalidomide-dexamethasone (Pd), lenalidomide-dexamethasone (Rd), or daratumumab-dexamethasone (Dd), in adult participants with relapsed/refractory (R/R) multiple myeloma (MM). Adverse events and change in disease activity 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. Etentamig co-administered with Pd, Rd, or Dd, will be explored. Each treatment arm receives a different treatment combination depending on stage of the study and eligibility. This study will include a dose escalation phase to determine the best dose of etentamig, followed by a dose expansion phase to confirm the dose. Approximately 320 adult participants with R/R MM will be enrolled in the study in approximately 48 sites worldwide.

Read more

Participants will receive intravenous (IV) etentamig co-administered with oral/IV Pd, oral/IV Rd, or oral/IV/subcutaneous (SC) Dd in 28-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, questionnaires and side effects.

Keywords
Relapsed/Refractory Multiple Myeloma, Pomalidomide, Dexamethasone, Lenalidomide, Daratumumab, Nirogacestat, Etentamig, ABBV-383, 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.

Study groups in NCT05259839
Study groupRoleWhat they receive
Part 1: Arm A (Etentamig with Pomalidomide and Dexamethasone)ExperimentalParticipants with relapsed or refractory (R/R) multiple myeloma (MM) who meet the criteria outline in the protocol will receive etentamig with Pomalidomide and Dexamethasone.
Receives: Drug: Etentamig; Drug: Dexamethasone; Drug: Pomalidomide
Part 1: Arm B (Etentamig with Lenalidomide and Dexamethasone)ExperimentalParticipants with R/R MM who meet the criteria outline in the protocol will receive etentamig with Lenalidomide and Dexamethasone.
Receives: Drug: Etentamig; Drug: Dexamethasone; Drug: Lenalidomide
Part 1: Arm C (Etentamig with Daratumumab and Dexamethasone)ExperimentalParticipants with R/R MM who meet the criteria outline in the protocol will receive etentamig with Daratumumab and Dexamethasone.
Receives: Drug: Etentamig; Drug: Dexamethasone; Drug: Daratumumab
Part 2: Arm E (Etentamig with Pomalidomide and Dexamethasone)ExperimentalParticipants with R/R MM who meet the criteria outline in the protocol will receive etentamig with Pomalidomide and Dexamethasone, after 1-3 prior lines of therapy.
Receives: Drug: Etentamig; Drug: Dexamethasone; Drug: Pomalidomide

What is being measured

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

  1. Number of Participants with Dose Limiting Toxicities (DLT) of Etentamig

    DLT events as described in the protocol will be assessed.

    Measured: Up to approximately 28 Days

  2. Number of Participants with Adverse Events (AEs)

    An 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. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above.

    Measured: Up to Approximately 3 Years

Secondary outcomes (5)

  1. Overall Response Rate (ORR)

    ORR is defined as partial response (PR) + very good partial response (VGPR) + complete remission (CR) + stringent complete response (sCR); proportion of participants who achieved a PR or better.

    Measured: Up to Approximately 3 Years

  2. 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 Approximately 3 Years

  3. Duration of Response (DOR)

    DOR will be 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 Approximately 3 Years

  4. Time-to-Progression (TTP)

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

    Measured: Up to Approximately 3 Years

  5. Percentage of Participants with Minimal Residual Diseas (MRD) Negativity by Next-Generation Sequencing (NGS)

    MRD negative status (threshold as assessed by NGS Adaptive Clonoseq) with >= CR (per International Myeloma Working Group [IMWG] response criteria) prior to the initiation of new myeloma therapy.

    Measured: Up to Approximately 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 posted2 Mar 2022
  2. Study start20 Oct 2022
  3. Primary completionSep 2033 (estimated)
  4. Study completionSep 2033 (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
Parallel groups
Masking
None (open label)
Enrolment
283 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05259839
Sponsor's protocol ID
M22-947
Other IDs
2023-506871-88-00, 2023
Status last verified
Aug 2026
First submitted
18 Feb 2022
Last updated
14 Aug 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, Dexamethasone and Lenalidomide in people with Relapsed/Refractory Multiple Myeloma, run by AbbVie at 49 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 7 inclusion and 12 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 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 49 sites in United States, Australia, Spain, Japan, Germany 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?

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 Participants with Dose Limiting Toxicities (DLT) of Etentamig (time frame: Up to approximately 28 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 NCT05259839.

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 14 Aug 2026.

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