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NCT06158841 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Multiple Myeloma, sponsored by AbbVie.

Recruiting
Registry status
Phase 3
Development phase
380
Enrollment target
20
Study locations

NCT06158841 is a Phase 3 study of Multiple Myeloma that is actively recruiting participants, run by AbbVie. The registered enrollment target is 380 participants, below the 546-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (30% lower). The trial reports 20 study locations across 11 states.

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The verdict

NCT06158841, a Phase 3 study of Multiple Myeloma, is actively recruiting participants, sponsored by AbbVie.

RECRUITING
Registry status
Phase 3
Development phase
380 participants
Enrollment target
20
Study locations

Study Summary

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.

Conditions Studied

Interventions

  • DRUG Selinexor
  • DRUG Pomalidomide
  • DRUG Carfilzomib
  • DRUG Elotuzumab
  • DRUG Etentamig

Study Locations (20)

California

  • Alta Bates Summit Medical Center for Research /ID# 261438 - Berkeley
  • Providence - St. Jude Medical Center /ID# 262031 - Fullerton
  • VA Loma Linda Healthcare System /ID# 261015 - Loma Linda
  • Cedars-Sinai Medical Center /ID# 261008 - Los Angeles

Illinois

  • University of Illinois Hospital and Health Sciences System /ID# 246349 - Chicago
  • Rush University Medical Center /ID# 265690 - Chicago
  • Nancy W. Knowles Cancer Center /ID# 271361 - Elmhurst
  • Springfield Clinic - First /ID# 262266 - Springfield

Florida

  • Mayo Clinic Hospital Jacksonville /ID# 263324 - Jacksonville
  • Cancer Specialists of North Florida - Jacksonville - AC Skinner Parkway /ID# 246230 - Jacksonville

Massachusetts

  • Beth Israel Deaconess Medical Center /ID# 271535 - Boston
  • Dana-Farber Cancer Institute /ID# 261554 - Boston

Michigan

  • Regents of the University of Michigan /ID# 261577 - Ann Arbor
  • Karmanos Cancer Institute - Detroit /ID# 266298 - Detroit

Alabama

  • University of Alabama at Birmingham - Main /ID# 261434 - Birmingham

Arizona

  • Mayo Clinic Hospital - Phoenix /ID# 263326 - Phoenix

Colorado

  • Rocky Mountain Cancer Centers - Lone Tree /ID# 278320 - Lone Tree

Trial Details

FieldValue
Enrollment Target 380 participants
Start Date 2024-05-19
Est. Completion 2027-12
Phase Phase 3

Sponsor

AbbVie

526 total trials

What the Registry Record Tells You About NCT06158841

The ClinicalTrials.gov registry entry for NCT06158841 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 380 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 546-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (30% lower). The listed sponsor is AbbVie, which has 526 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Multiple Myeloma appearing as the primary indexed condition, and to 5 interventions - of which Selinexor is the first listed.

NCT06158841 reports 20 study locations spanning 11 distinct geographic areas - top geographies include California, Illinois, Florida.

Frequently Asked Questions

What is clinical trial NCT06158841 about?

NCT06158841 is a clinical study titled "Study Assessing Activity of Intravenous (IV) Etentamig Monotherapy Versus Standard Available Therapies in Adult Participants With Relapsed or Refractory Multiple Myeloma". 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...

What is the current status of trial NCT06158841?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 380 participants. The study started on 2024-05-19. Estimated completion is 2027-12.

What conditions does trial NCT06158841 study?

This clinical trial studies the following conditions: Multiple Myeloma.

What interventions are being tested in trial NCT06158841?

The interventions under investigation include: Selinexor (DRUG), Pomalidomide (DRUG), Carfilzomib (DRUG), Elotuzumab (DRUG), Etentamig (DRUG).

Who is sponsoring clinical trial NCT06158841?

This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06158841 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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