A Study to Evaluate Adverse Events and Change in Disease Activity With Injected Etentamig Plus Oral Pomalidomide Versus Standard Therapies in Adults With Relapsed or Refractory Multiple Myeloma

Part of paid clinical trials in Tucson, Arizona.

Sponsor
AbbVie
Study ID
NCT07728188
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Relapsed or Refractory Multiple Myeloma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Etentamig — DRUG
    Injection
  • Pomalidomide — DRUG
    Oral
  • Daratumumab — DRUG
    Injection
  • Dexamethasone — DRUG
    Oral or Injection
  • Carfilzomib — DRUG
    Injection
  • Teclistamab — DRUG
    Injection

Study Details

Multiple myeloma (MM) is a plasma cell malignancy characterized by the proliferation of clonal plasma cells in the bone marrow. The disease primarily localizes to the bones and bone marrow, with resultant cytopenias, bone pain, fractures, infections, hypercalcemia, and renal failure. This study aims to evaluate the safety and change in disease activity of etentamig in combination with pomalidomide compared with standard available therapies in participants with relapsed or refractory multiple myeloma who have received 1-3 prior lines of treatment, including lenalidomide. Etentamig is an investigational drug being developed for the treatment of relapsed or refractory multiple myeloma. This is a randomized, open-label study. The study will include a safety run-in portion and a randomized portion. The safety run-in participants will receive etentamig in combination with pomalidomide. The randomized portion of the study participants will receive either etentamig with pomalidomide or Standard Available Therapies (SATs). Approximately 520 participants will be enrolled in the study at approximately 200 sites worldwide. Prior to initiation of the randomized portion of the study, the safety run-in will be conducted in which participants will receive etentamig injections plus oral pomalidomide. Following review of the safety run-in data and per protocol-defined criteria, the study will advance to the randomized portion where participants will be randomized to receive either etentamig injections plus oral pomalidomide or investigator's choice of SAT: SC daratumumab, oral pomalidomide, and oral/ IV dexamethasone (DPd); SC daratumumab, IV carfilzomib, and oral/IV dexamethasone (DKd); or SC teclistamab monotherapy. The total study duration is approximately 75 months There may be higher treatment burden for participants in this trial compared to their standard of care due to study procedures. Participants will attend regular visits during the study at a hospital or clinic. The effects of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Key Dates

First listed
Jul 27, 2026
Start date
Nov 30, 2026
Status verified
Jul 2026
Primary completion
Feb 28, 2033
Completion
Feb 28, 2033

Study Design

Enrollment
520 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Safety Run-In: Etentamig Plus Pomalidomide
    Participants will receive etentamig in combination with pomalidomide, as part of the approximately 75 month study duration.
  • Experimental: Randomized Portion: Etentamig Plus Pomalidomide
    Participants will receive etentamig in combination with pomalidomide, as part of the approximately 75 month study duration.
  • Active Comparator: Randomized Portion: Standard Available Therapy (SAT)
    Participants will receive Investigator's choice of SATs: DPd, DKd, or teclistamab monotherapy as part of the 75 month study duration.

Primary Outcome Measure

Safety Run-In: Number of Participants With Adverse Events (AE)s [ Time Frame: Up to Approximately 75 Months ]

Central Contacts

Locations (24)

FacilityCityStateZIPSite coordinators
University of Arizona Cancer Center /ID# 285339TucsonArizona85704-
Toi Clinical Research - Whittier /ID# 284462CerritosCalifornia90703-
University of California Los Angeles /ID# 282444Los AngelesCalifornia90095-3075-
University Of Colorado - Anschutz Medical Campus /ID# 283478AuroraColorado80045-
MedStar Georgetown University Hospital /ID# 283734Washington D.C.District of Columbia20007-
Cleveland Clinic Florida /ID# 283692WestonFlorida33331-
Northwest Georgia Oncology Centers /ID# 284769MariettaGeorgia30060-
Rush University Medical Center /ID# 283095ChicagoIllinois60612-
Beth Israel Deaconess Medical Center /ID# 285204BostonMassachusetts02215-
Cancer And Hematology Centers Of Western Michigan - Grand Rapids /ID# 282591Grand RapidsMichigan49503-
Columbia University Medical Center /ID# 283510New YorkNew York10032-
The Mount Sinai Hospital /ID# 283535New YorkNew York10029-
Weill Cornell Medicine - Cornell University /ID# 283712New YorkNew York10065-
University of Rochester Medical Center /ID# 283480RochesterNew York14642-
University of North Carolina Lineberger Comprehensive Cancer Center /ID# 281454Chapel HillNorth Carolina27599-
Duke University Medical Center /ID# 283475DurhamNorth Carolina27710-
Novant Health Forsyth Medical Center /ID# 283485Winston-SalemNorth Carolina27103-
University Hospitals Cleveland Medical Center /ID# 283527ClevelandOhio44106-
Oregon Health and Science University /ID# 282023PortlandOregon97239-
SCRI Oncology Partners /ID# 281380NashvilleTennessee37203-
MD Anderson Houston /ID# 282622HoustonTexas77030-4000-
Huntsman Cancer Institute /ID# 283512Salt Lake CityUtah84112-
VCU Massey Cancer Center: Dalton Oncology Clinic /ID# 283606RichmondVirginia23298-
University of Wisconsin Hospitals and Clinics /ID# 282516MadisonWisconsin53792-

Find similar trials in Tucson, AZ

By research site
University of Arizona Cancer Center· Tucson, AZToi Clinical Research - Whittier· Cerritos, CAUniversity of California Los Angeles· Los Angeles, CAUniversity Of Colorado - Anschutz Medical Campus· Aurora, COMedStar Georgetown University Hospital· Washington D.C., DCCleveland Clinic Florida· Weston, FL

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