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Looking for participantsPhase1

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

Sponsor: AbbVie

NCT ID: NCT05650632

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Etentamig (ABBV-383) (drug)
How long the study runs
Study runs about 77 months (dates as stated)
About the drug or intervention
Etentamig (ABBV-383) — drug: Intravenous Infusion
Patient visit burden
Not specified by the sponsor

In plain English

This AbbVie study is testing a drug called etentamig (ABBV-383), given through a drip into a vein (intravenously), in adults with multiple myeloma that has come back or not responded to treatment (relapsed or refractory). The study is looking at side effects of the drug. Participants must not have had etentamig before.

Who can take part

  • Adults with relapsed or refractory multiple myeloma that got worse during or after their last treatment
  • Must have measurable disease, as set out in the trial's own rules
  • Must be well enough for daily activities (a performance score of 2 or below; in Arms C and D, 1 or below)
  • Must not have had etentamig (ABBV-383) before
  • Arm A: have had at least 3 previous treatments, including a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 monoclonal antibody (a type of targeted antibody treatment)
  • Arm B: have had at least 2 previous treatments, including a proteasome inhibitor, an immunomodulatory drug, an anti-CD38 monoclonal antibody, and earlier treatment targeting BCMA (either an antibody-drug conjugate or CAR T-cell therapy)
  • Arm C: have had at least 2 previous treatments, including a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 monoclonal antibody, and be able to receive the drug as an outpatient (without staying in hospital)
  • Arm D: have had between 1 and 3 previous treatments, including a proteasome inhibitor, an immunomodulatory drug, or an anti-CD38 monoclonal antibody, and be able to receive the drug as an outpatient

Who may not be able to

  • Arm A: people who have had any treatment targeting BCMA
  • Arms C and D: people whose disease is progressing very quickly, in the investigator's view

What taking part involves

  • • Etentamig (ABBV-383) given as an infusion into a vein (a drip)

Time commitment: Treatment is given through a drip into a vein; number of visits and how long the study lasts are not stated — ask the trial team.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
210
Started
2023-03-21
Last checked
2026-07

Plain English Summary

What is this study?

  • • Testing a new treatment for multiple myeloma
  • • Phase1 - 210 participants
  • • Multiple Myeloma (MM) is a cancer of the blood's plasma cells ( blood cell)

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with multiple myeloma

Where?

  • • London - University College London Hospital /ID# 251357
  • • Manchester - The Christie Hospital /ID# 251774

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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. 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.

Multiple Myeloma

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Biomarkers mentioned

CD38

Treatment history

Treatments you must have had:

  • ✓ measurable disease as outlined in the protocol

What the study is looking for

  • ✓Must have cancer that can be measured on scans as outlined in the protocol.
  • ✓activity scale (ECOG) performance of \<= 2. Arm C and Arm D: ECOG performance of \<= 1.
  • ✓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...

Who cannot take part

  • ✗Arm A: Received BCMA-treatment that targets specific changes in the cancer.
  • ✗Arm C and Arm D: Rapidly progressing disease per investigator.
See the full criteria
Inclusion Criteria: * 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). Exclusion Criteria: * Arm A: Received BCMA-targeted therapy. * Arm C and Arm D: Rapidly progressing disease per investigator.

Where Is This Study? (2 UK sites)

University College London Hospital /ID# 251357

London NW1 2BU, United Kingdom

Recruiting

The Christie Hospital /ID# 251774

Manchester M20 4BX, United Kingdom

Recruiting
Site contact (verified)
Site Coordinator0161 446 3285

How to Get in Touch

ABBVIE CALL CENTER

Sponsor contact

CONTACT

844-663-3742 abbvieclinicaltrials@abbvie.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-07