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ACTIVE NOT RECRUITINGPhase3

Study Assessing Activity of Intravenous (IV) Etentamig Monotherapy Versus Standard Available Therapies in Adult Participants With Relapsed or Refractory Multiple Myeloma

Sponsor: AbbVie

NCT ID: NCT06158841

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 (drug), Carfilzomib (drug), Pomalidomide (drug), Elotuzumab (drug)
How long the study runs
Study runs about 43 months (dates as stated)
About the drug or intervention
Etentamig — drug: Intravenous (IV) Infusion · Carfilzomib — drug: IV Infusion · Pomalidomide — drug: Oral Capsule · Elotuzumab — drug: IV Infusion · Selinexor — drug: Oral Tablet · Bortezomib — drug: Subcutaneous or IV Injection · Dexamethasone — drug: Oral Tablet or IV Infusion
Patient visit burden
Not specified by the sponsor

In plain English

This study tests a drug called etentamig, given through a drip into a vein (intravenous), on its own in adults whose multiple myeloma has come back or stopped responding to treatment (relapsed or refractory). It compares etentamig with standard treatments chosen by the doctor. The study is funded by AbbVie.

Who can take part

  • Adults with relapsed or refractory multiple myeloma diagnosed during or after their last treatment, as set out in the study plan.
  • Fairly well day-to-day: an Eastern Cooperative Oncology Group (ECOG) score of 2 or less (a scale of how well you can carry out daily activities).
  • Measurable disease shown by tests within 28 days of joining — for example, a certain level of abnormal protein in the blood or urine, or abnormal free light chains (a type of protein) in the blood.
  • Have already had at least 2 lines of myeloma treatment, including a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 monoclonal antibody (three common types of myeloma medicine). People joining in the US or Puerto Rico only need at least 1 previous line, as long as it included those three types.
  • Able to safely receive a standard available therapy chosen by the doctor, based on the medicine's approved information, past treatment, and hospital guidelines.

Who may not be able to

  • Drug or alcohol misuse in the last 6 months that the doctor considers significant.
  • Other significant health conditions in the last 6 months (for example affecting the nerves, mind, hormones, metabolism, immune system, heart, lungs, or liver) that would affect taking part, in the doctor's view.
  • Myeloma that has spread to the brain or spinal cord (central nervous system).
  • Previous treatment targeting BCMA (B-cell maturation antigen, a protein on myeloma cells).

What taking part involves

  • • Etentamig given alone through a drip into a vein, or
  • • A standard available therapy for multiple myeloma chosen by your doctor.

Time commitment: Not stated — ask the trial team about how many visits are needed, how long the study lasts, and what tests or procedures taking part would involve.

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
421
Started
2024-05-19
Last checked
2026-08

Plain English Summary

What is this study?

  • • Testing a new treatment for multiple myeloma
  • • Phase3 - 421 participants
  • • Multiple myeloma (MM) is a cancer of the blood's plasma cells

Who can take part?

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

Where?

  • • Cambridge - Addenbrookes Hospital /ID# 261104
  • • Edinburgh - Western General Hospital /ID# 261106
  • • London - Dup_Guys and St Thomas NHS Foundation Trust - Guy's Hospital /ID# 262488
  • • Nottingham - Nottingham City Hospital /ID# 261105
  • • +3 more UK sites

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. 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 change in disease symptoms of etentamig compared to standard available therapies in adult participants with relapsed/refractory (R/R) MM. Etentamig is an investigational drug being developed for the treatment of R/R MM. This study is broken into 2 Arms; Arm A and Arm B. In Arm A, participants will receive etentamig as a monotherapy. In Arm B, participants will receive the standard available therapy (SAT) identified by the Investigator during screening, in accordance with the local (or applicable) approved label, package insert, summary of product characteristics, and/or the institutional guidelines, as applicable. Around 380 adult participants with relapsed/refractory multiple myeloma will be enrolled at approximately 140 sites across the world. In Arm A participants will receive etentamig as an infusion into the vein in 28 day cycles, during the 3.5 year study duration. In Arm B, participants will receive the SAT identified by the Investigator during screening, in accordance with the local (or applicable) approved label, package insert, summary of product characteristics, and/or the institutional guidelines, as applicable, during the 3.5 year 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.

Multiple Myeloma

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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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 with at least 1 of the following assessed within 28 days of enrollment:

What the study is looking for

  • ✓activity scale (ECOG) performance of \<= 2.
  • ✓Diagnosis of relapsed/refractory (R/R) multiple myeloma (MM) during or after the participant's last treatment as...
  • ✓Must have cancer that can be measured on scans with at least 1 of the following assessed within 28 days of enrollment:
  • ✓Serum M-protein \>= 0.5 g/dL (\>= 5 g/L).
  • ✓Urine M-protein \>= 200 mg/24 hours.

Who cannot take part

  • ✗Clinically significant (per Investigator's judgment) drug or alcohol abuse within the last 6 months.
  • ✗Central nervous system involvement of MM.
  • ✗Has received B-cell maturation antigen (BCMA)-treatment that targets specific changes in the cancer.
See the full criteria
Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance of \<= 2. * Diagnosis of relapsed/refractory (R/R) multiple myeloma (MM) during or after the participant's last treatment as stated in the protocol. * Must have measurable disease with at least 1 of the following assessed within 28 days of enrollment: * Serum M-protein \>= 0.5 g/dL (\>= 5 g/L). * Urine M-protein \>= 200 mg/24 hours. * In participants without measurable serum or urine M protein, serum free light chain (FLC) \>= 100 mg/L (10 mg/dL) (involved light chain)and an abnormal serum kappa lambda ratio. * Must have received at least 2 or more lines of therapy, including a proteasome inhibitor (PI), an immunomodulatory imide (IMiD), and an anti-CD38 monoclonal antibody (mAb). \-- US and Puerto Rico only: Participant must have received at least 1 or more line of therapy, including exposure to a PI, an IMiD, and an anti-CD38 mAb. * Must be eligible to receive the Investigator's choice standard available therapy (SAT) based on approved prescribing information, previous MM treatment history, and institutional guidelines. Exclusion Criteria: * Clinically significant (per Investigator's judgment) drug or alcohol abuse within the last 6 months. * Clinically significant conditions such as but not limited to the following: neurologic, psychiatric, endocrine, metabolic, immunologic, cardiovascular, pulmonary, or hepatic disease within the last 6 months that would adversely affect the participant's participation in the study. * Central nervous system involvement of MM. * Has received B-cell maturation antigen (BCMA)-targeted therapy.

Where Is This Study? (7 UK sites)

Addenbrookes Hospital /ID# 261104

Cambridge CB2 2QQ, United Kingdom

Western General Hospital /ID# 261106

Edinburgh EH4 2XU, United Kingdom

Dup_Guys and St Thomas NHS Foundation Trust - Guy's Hospital /ID# 262488

London SE1 9RT, United Kingdom

Hospital R&D contact (matched)

Main Email: gstt.RandD@nhs.net

gstt.RandD@nhs.net---

Nottingham City Hospital /ID# 261105

Nottingham NG5 1PB, United Kingdom

Hospital R&D contact (matched)

Alison Lloyd

nuhnt.researchsponsor@nhs.net0115 9249924

Leeds Teaching Hospitals NHS Trust /ID# 261101

Leeds LS9 7TF, United Kingdom

Hospital R&D contact (matched)

R&I Team

leedsth-tr.researchfacilitation@nhs.net0113 2060469

The Royal Marsden NHS Foundation Trust /ID# 262470

London SW3 6JJ, United Kingdom

Hospital R&D contact (matched)

Mark Brandon-Grove

research.development@rmh.nhs.uk020 3186 5416

The Christie Hospital /ID# 261102

Manchester M20 4BX, United Kingdom

Hospital R&D contact (matched)

Research and Innovation Office

the-christie.ri@nhs.net---
Data sourced from ClinicalTrials.gov · Last verified: 2026-08