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RecruitingInterventionalPhase 3

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)

NCT ID: NCT06158841Sponsor: AbbVieLast updated: 2026-06-16

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.

Arms & interventions

  • DrugEtentamig

    Intravenous (IV) Infusion

  • DrugCarfilzomib

    IV Infusion

  • DrugPomalidomide

    Oral Capsule

  • DrugElotuzumab

    IV Infusion

  • DrugSelinexor

    Oral Tablet

  • DrugBortezomib

    Subcutaneous or IV Injection

  • DrugDexamethasone

    Oral Tablet or IV Infusion

Outcome measures

Primary

  • Progression Free Survival (PFS)

    PFS is defined as the duration from the date of randomization to the date of confirmed disease progression (PD) determined by independent review committee (IRC) per international myeloma working group (IMWG) (2016) response criteria, or death, whichever occurs first.

    Time frame: Up to Approximately 5 Years

  • Objective Response Rate (ORR)

    ORR is defined as the percentage of participants who achieve confirmed partial response (PR) + VGPR + complete response (CR) + stringent complete response (sCR) or per IRC assessment.

    Time frame: Up to Approximately 5 Years

Secondary

  • Overall Survival (OS)

    Time frame: Up to Approximately 5 Years

  • Change in Rate of Very Good Partial Response (VGPR) or Better (>= VGPR)

    Time frame: Up to Approximately 5 Years

  • Change in Rate of CR or Better (>=CR)

    Time frame: Up to Approximately 5 Years

  • Change in Rate of Minimum Residual Disease (MRD) negativity with >= CR

    Time frame: Up to Approximately 5 Years

  • Change from Baseline in Disease Symptoms as Measured by the Disease Symptoms Domain of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Multiple Myeloma Module (EORTC QLQ-MY20)

    Time frame: Up to 6 Months

  • Change from Baseline in Physical Functioning as Measured by the Physical Functioning Domain of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30)

    Time frame: Up to 6 Months

  • Time to Response (TTR)

    Time frame: Up to Approximately 5 Years

  • Duration of Response (DOR)

    Time frame: Up to Approximately 5 Years

  • Time-to-Progression (TTP)

    Time frame: Up to Approximately 5 Years

  • Time to Next Anti-lymphoma Therapy (TTNT)

    Time frame: Up to Approximately 5 Years

  • Number of Participants with Event-free Survival (EFS)

    Time frame: Up to Approximately 5 Years

  • Change from Baseline in Patient-Reported Outcomes Measurement Information System Fatigue Short Form 7a (PROMIS Fatigue SF 7a)

    Time frame: Up to Approximately 6 Months

  • Change from Baseline in Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE)

    Time frame: Up to Approximately 6 Months

  • Change from Baseline in Remaining Items in the EORTC QLQ-C30

    Time frame: Up to Approximately 6 Months

  • Change from Baseline in Remaining Items in the EORTC QLQ-MY20

    Time frame: Up to Approximately 6 Months

  • Change from Baseline in European Quality-of-Life 5-dimensional-5-level (EQ-5D-5L)

    Time frame: Up to Approximately 6 Months

  • Change from Baseline in Patient Global Impression of Severity (PGIS)

    Time frame: Up to Approximately 6 Months

  • Change from Baseline in Patient Global Impression of Change (PGIC)

    Time frame: Up to Approximately 6 Months

  • Number of Participants with Skeletal-Related Event (SRE)

    Time frame: Up to Approximately 5 Years

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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.

Study locations (46)

University of Alabama at Birmingham - Main /ID# 261434

Birmingham, Alabama, 35233

Recruiting

Mayo Clinic Hospital - Phoenix /ID# 263326

Phoenix, Arizona, 85054

Recruiting

Alta Bates Summit Medical Center for Research /ID# 261438

Berkeley, California, 94705

Completed

Providence - St. Jude Medical Center /ID# 262031

Fullerton, California, 92835

Recruiting

VA Loma Linda Healthcare System /ID# 261015

Loma Linda, California, 92357

Recruiting

Cedars-Sinai Medical Center /ID# 261008

Los Angeles, California, 90048

Recruiting

Rocky Mountain Cancer Centers - Lone Tree /ID# 278320

Lone Tree, Colorado, 80124

Recruiting

Mayo Clinic Hospital Jacksonville /ID# 263324

Jacksonville, Florida, 32224

Recruiting

Cancer Specialists of North Florida - Jacksonville - AC Skinner Parkway /ID# 246230

Jacksonville, Florida, 32256

Recruiting
Site Coordinator · Contact
904-538-4488

Winship Cancer Institute of Emory University /ID# 262525

Atlanta, Georgia, 30322

Recruiting

University of Illinois Hospital and Health Sciences System /ID# 246349

Chicago, Illinois, 60607

Recruiting

Rush University Medical Center /ID# 265690

Chicago, Illinois, 60612

Completed

Nancy W. Knowles Cancer Center /ID# 271361

Elmhurst, Illinois, 60126

Recruiting

Springfield Clinic - First /ID# 262266

Springfield, Illinois, 62702

Recruiting

Our Lady Of The Lake Regional Medical Center /ID# 272780

Baton Rouge, Louisiana, 70808

Recruiting

Center for Cancer and Blood Disorders-American Oncology Partners of Maryland /ID# 263637

Bethesda, Maryland, 20817

Recruiting

Beth Israel Deaconess Medical Center /ID# 271535

Boston, Massachusetts, 02215

Recruiting

Dana-Farber Cancer Institute /ID# 261554

Boston, Massachusetts, 02215

Recruiting

Regents of the University of Michigan /ID# 261577

Ann Arbor, Michigan, 48109-1276

Recruiting

Karmanos Cancer Institute - Detroit /ID# 266298

Detroit, Michigan, 48201

Recruiting

Henry Ford Hospital /ID# 262704

Detroit, Michigan, 48202

Completed

Barbara Ann Karmanos Cancer Institute - McLaren Greater Lansing /ID# 259891

Lansing, Michigan, 48912

Recruiting

Mayo Clinic - Rochester /ID# 246228

Rochester, Minnesota, 55905-0001

Recruiting

University of Missouri Hospital /ID# 261553

Columbia, Missouri, 65212

Completed

Nebraska Cancer Specialists - Omaha - Wright Street /ID# 276772

Omaha, Nebraska, 68130

Recruiting

New York Cancer & Blood Specialists - Bay Shore /ID# 261524

Bay Shore, New York, 11706

Recruiting

New York Cancer & Blood Specialists - Lake Success Medical Oncology /ID# 262953

New Hyde Park, New York, 11042

Completed

New York Cancer and Blood Specialists - New York /ID# 262951

New York, New York, 10028

Completed

Eastchester Center for Cancer Care /ID# 262952

The Bronx, New York, 10469

Recruiting

University of North Carolina /ID# 259854

Chapel Hill, North Carolina, 27514

Recruiting

Atrium Health Levine Cancer Institute /ID# 246199

Charlotte, North Carolina, 28204

Recruiting

Duke University Medical Center /ID# 259694

Durham, North Carolina, 27710

Completed

University Of Cincinnati Medical Center /ID# 246415

Cincinnati, Ohio, 45219

Recruiting

Cleveland Clinic Main Campus /ID# 246183

Cleveland, Ohio, 44195

Recruiting

Oregon Medical Research Center /ID# 262335

Portland, Oregon, 97239

Recruiting

Medical University of South Carolina /ID# 259692

Charleston, South Carolina, 29425

Recruiting

University of Tennessee Health Science Center /ID# 261622

Memphis, Tennessee, 38103

Recruiting

Baptist Memorial Hospital /ID# 270910

Memphis, Tennessee, 38120

Recruiting

The West Clinic /ID# 262444

Memphis, Tennessee, 38120

Recruiting
Site Coordinator · Contact
9016830055

Vanderbilt University Medical Center /ID# 261621

Nashville, Tennessee, 37232-0011

Recruiting

Oncology Consultants /ID# 276774

Houston, Texas, 77030

Recruiting

Texas Oncology - Northeast Texas /ID# 278304

Tyler, Texas, 75702

Recruiting

Virginia Cancer Specialists - Fairfax /ID# 262792

Fairfax, Virginia, 22031

Recruiting

Virginia Oncology Associates - Norfolk (Lake Wright) /ID# 278314

Norfolk, Virginia, 23502

Recruiting

VCU Massey Cancer Center: Dalton Oncology Clinic /ID# 261944

Richmond, Virginia, 23298

Recruiting

Northwest Medical Specialties Tacoma /ID# 276281

Tacoma, Washington, 98405

Recruiting