RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase 3, Multicenter, Randomized, Open Label Study of Etentamig Compared With Standard Available Therapies in Subjects With Relapsed or Refractory Multiple Myeloma (3L+ RRMM Monotherapy Study)

Quick Facts

Study Start:2024-05-19
Study Completion:2027-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06158841

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Eastern Cooperative Oncology Group (ECOG) performance of \<= 2.
  2. * Diagnosis of relapsed/refractory (R/R) multiple myeloma (MM) during or after the participant's last treatment as stated in the protocol.
  3. * Must have measurable disease with at least 1 of the following assessed within 28 days of enrollment:
  4. * Serum M-protein \>= 0.5 g/dL (\>= 5 g/L).
  5. * Urine M-protein \>= 200 mg/24 hours.
  6. * 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.
  7. * 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).
  8. * 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.
  1. * Clinically significant (per Investigator's judgment) drug or alcohol abuse within the last 6 months.
  2. * 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.
  3. * Central nervous system involvement of MM.
  4. * Has received B-cell maturation antigen (BCMA)-targeted therapy.

Contacts and Locations

Study Contact

ABBVIE CALL CENTER
CONTACT
844-663-3742
abbvieclinicaltrials@abbvie.com

Principal Investigator

ABBVIE INC.
STUDY_DIRECTOR
AbbVie

Study Locations (Sites)

Alta Bates Summit Medical Center for Research /ID# 261438
Berkeley, California, 94705
United States
Providence - St. Jude Medical Center /ID# 262031
Fullerton, California, 92835
United States
Cedars-Sinai Medical Center /ID# 261008
Los Angeles, California, 90048
United States
Cancer Specialists of North Florida /ID# 246230
Jacksonville, Florida, 32256
United States
University of Illinois at Chicago /ID# 246349
Chicago, Illinois, 60607
United States
Springfield Clinic /ID# 262266
Springfield, Illinois, 62702-3749
United States
Center for Cancer and Blood Disorders /ID# 263637
Bethesda, Maryland, 20817
United States
Regents of the University of Michigan /ID# 261577
Ann Arbor, Michigan, 48109-1276
United States
Karmanos Cancer Institute - Detroit /ID# 266298
Detroit, Michigan, 48201
United States
Henry Ford Hospital /ID# 262704
Detroit, Michigan, 48202
United States
New York Cancer & Blood Specialists - Bay Shore /ID# 261524
Bay Shore, New York, 11706
United States
Eastchester Center for Cancer Care /ID# 262952
Bronx, New York, 10469
United States
New York Cancer & Blood Specialists - Lake Success Medical Oncology /ID# 262953
New Hyde Park, New York, 11042
United States
New York Cancer and Blood Specialists - New York /ID# 262951
New York, New York, 10028
United States
University of North Carolina /ID# 259854
Chapel Hill, North Carolina, 27514
United States
Levine Cancer Institute /ID# 246199
Charlotte, North Carolina, 28204
United States
University Of Cincinnati Medical Center /ID# 246415
Cincinnati, Ohio, 45219
United States
Cleveland Clinic Main Campus /ID# 246183
Cleveland, Ohio, 44195
United States
Virginia Cancer Specialists - Fairfax /ID# 262792
Fairfax, Virginia, 22031
United States

Collaborators and Investigators

Sponsor: AbbVie

  • ABBVIE INC., STUDY_DIRECTOR, AbbVie

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-19
Study Completion Date2027-12

Study Record Updates

Study Start Date2024-05-19
Study Completion Date2027-12

Terms related to this study

Keywords Provided by Researchers

  • Cervino
  • Multiple Myeloma
  • Etentamig
  • Carfilzomib
  • Pomalidomide
  • Elotuzumab
  • Selinexor
  • Bortezomib
  • Dexamethasone

Additional Relevant MeSH Terms

  • Multiple Myeloma