RecruitingPhase 1Phase 2NCT06892522

A Study to Assess Change in Disease Activity and Adverse Events (AE)s in Adult Participants With Multiple Myeloma Receiving Etentamig (ABBV-383) as an Intravenous (IV) Infusion Alone or in Combination With Oral, IV, Subcutaneous Daratumumab; Lenalidomide; Dexamethasone; Carfilzomib

A Phase 1/2, Open-Label, Platform Study to Evaluate Safety and Efficacy of Etentamig Monotherapy or Etentamig Combinations in Subjects With Multiple Myeloma


Sponsor

AbbVie

Enrollment

440 participants

Start Date

Jun 30, 2025

Study Type

INTERVENTIONAL

Conditions

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 the safety, efficacy, and pharmacokinetics of Etentamig in adult participants with MM. Etentamig is an investigational drug being developed for the treatment of MM. This study is broken into 4 substudies and each substudy consists of a dose escalation phase and dose expansion phase. Participants will receive escalating doses of etentamig alone or in combination with daratumumab and lenalidomide (DR), carfilzomib and dexamethasone (Kd) or lenalidomide (R). This will be followed by etentamig at the dose levels established during the escalation phases alone or in combination with DR, Kd, R. The participants can also receive daratumumab, lenalidomide and dexamethasone (DRd), R, or daratumumab, carfilzomib, and dexamethasone (DKd) as a comparator in the dose expansion phases. Around 440 adult participants with MM will be enrolled at approximately 50 sites worldwide In all substudies, participants will receive escalating doses of etentamig as Intravenous (IV) infusions, alone or in combination with DR, R or Kd, followed by IV infusions of etentamig at the dose levels established during the escalation phases alone or in combination with IV and oral DRd, DKd, or R. The study duration is approximately 130 months. 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.


Eligibility

Min Age: 18 Years

Inclusion Criteria2

  • Eastern cooperative oncology group (ECOG) performance of \<= 1.
  • Confirmed diagnosis of multiple myeloma (MM) according to the International Myeloma Working Group (IMWG) diagnostic criteria with either newly diagnosed or relapsed or refractory (RR) MM, depending on the substudy.

Exclusion Criteria2

  • Participant who has known active central nervous system involvement of MM.
  • Participant who has known active infection as outlined in the protocol.

Interventions

DRUGEtentamig

Intravenous (IV) Infusion

DRUGLenalidomide

Oral Capsule

DRUGDexamethasone

IV Injection

DRUGDaratumumab

Subcutaneous Injection

DRUGDexamethasone

Oral Tablet

DRUGCarfilzomib

IV Infusion


Locations(25)

Colorado Blood Cancer Institute /ID# 273129

Denver, Colorado, United States

Moffitt Cancer Center /ID# 272628

Tampa, Florida, United States

Winship Cancer Institute of Emory University /ID# 274830

Atlanta, Georgia, United States

Weill Cornell Medical College /ID# 272517

New York, New York, United States

University of North Carolina at Chapel Hill /ID# 274667

Chapel Hill, North Carolina, United States

Atrium Health Levine Cancer Institute /ID# 276193

Charlotte, North Carolina, United States

Atrium Health Wake Forest Baptist Medical Center /ID# 274847

Winston-Salem, North Carolina, United States

Oncology Hematology Care - Kenwood /ID# 272918

Cincinnati, Ohio, United States

Coffs Harbour Health Campus /ID# 272010

Coffs Harbour, New South Wales, Australia

Port Macquarie Base Hospital /ID# 275925

Port Macquarie, New South Wales, Australia

Westmead Hospital /ID# 271880

Westmead, New South Wales, Australia

Icon Cancer Care - South Brisbane /ID# 271836

South Brisbane, Queensland, Australia

Royal Adelaide Hospital /ID# 272629

Adelaide, South Australia, Australia

St Vincent's Hospital - Melbourne /ID# 276451

Fitzroy, Victoria, Australia

Peter MacCallum Cancer Centre /ID# 272024

Melbourne, Victoria, Australia

The Perth Blood Institute - West Perth /ID# 272469

West Perth, Western Australia, Australia

Soroka Medical Center /ID# 271367

Beersheba, Southern District, Israel

The Chaim Sheba Medical Center /ID# 271366

Ramat Gan, Tel Aviv, Israel

Rambam Health Care Campus- Haifa /ID# 271364

Haifa, Israel

Hadassah Medical Center-Hebrew University /ID# 271362

Jerusalem, Israel

Rabin Medical Center. /ID# 271365

Petah Tikva, Israel

Nagoya City University Hospital /ID# 273529

Nagoya, Aichi-ken, Japan

University Hospital Kyoto Prefectural University of Medicine /ID# 275713

Kyoto, Kyoto, Japan

The University of Osaka Hospital /ID# 275791

Suita-shi, Osaka, Japan

Hammersmith Hospital /ID# 274615

London, England, United Kingdom

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NCT06892522


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