Back to Trials
NCT06892522PHASE1, PHASE2Recruiting

A Study to Assess Change in Disease Activity and Adverse Events (AE)s in Adult Participants With Multiple Myeloma Receiving T Cell Engaging Bi/Tri-specific Antibodies Intravenously (IV)/Subcutaneously (SC) Alone or in Combinations

AbbVie

Start Date

6/30/2025

Completion Date

12/1/2035

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 and ABBV-2001 in adult participants with MM. Etentamig and ABBV-2001 are investigational drugs being developed for the treatment of MM. This study is broken into 6 substudies and each substudy consists of a dose escalation phase and dose expansion phase. Participants in substudies 1-4 will receive escalating doses of etentamig alone or with daratumumab and lenalidomide (DR), carfilzomib and dexamethasone (Kd) or lenalidomide (R), followed by etentamig at the dose levels established during the escalation phases alone or with DR, Kd, R. Participants in substudies 1-4 can also receive daratumumab, lenalidomide and dexamethasone (DRd), R, or daratumumab, carfilzomib, and dexamethasone (DKd) as a comparator in the dose expansion phases. Participants in substudies 5-6 will receive escalating doses or at the dose levels established during the escalation phases of ABBV-2001 with iberdomide or mezigdomide. Around 602 adult participants with MM will be enrolled at approximately 75 sites worldwide In substudies 1-3, participants will receive escalating doses of etentamig as Intravenous (IV) infusions, alone or with DR, R or Kd, followed by IV infusions of etentamig at the dose levels established during the escalation phases alone or with IV and DRd, DKd, or R. In substudie 4, participants will receive escalating doses of etentamig as Intravenous (IV) infusions followed by IV infusions of etentamig at the dose levels established during the escalation phase. In substudies 5-6, participants will receive escalating doses of ABBV-2001 as subcutaneous (SC) injections, with oral iberdomide or mezigdomide, followed by SC injections of ABBV-2001 at the dose levels established during the escalation phases with oral iberdomide or mezigdomide. 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 Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * 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 Criteria: * Participant who has known active central nervous system involvement of MM. * Participant who has known active infection as outlined in the protocol.

Interventions

DRUG

Etentamig

DRUG

Lenalidomide

DRUG

Dexamethasone

DRUG

Daratumumab

DRUG

Dexamethasone

DRUG

Carfilzomib

DRUG

Mezigdomide

DRUG

Iberdomide

DRUG

ABBV-2001

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Multiple Myeloma

Locations

City of Hope National Medical Center /ID# 273132

Duarte, California 91010

United States

City of Hope - Orange County Lennar Foundation Cancer Center /ID# 277911

Irvine, California 92618

United States

Colorado Blood Cancer Institute /ID# 273129

Denver, Colorado 80218

United States

Moffitt Cancer Center /ID# 272628

Tampa, Florida 33612

United States

Winship Cancer Institute of Emory University /ID# 274830

Atlanta, Georgia 30322

United States

Mount Sinai - The Tisch Cancer Institute /ID# 272470

New York, New York 10029

United States

Weill Cornell Medical College /ID# 272517

New York, New York 10065

United States

University of North Carolina at Chapel Hill /ID# 274667

Chapel Hill, North Carolina 27514

United States

Atrium Health Levine Cancer Institute /ID# 276193

Charlotte, North Carolina 28204-2990

United States

Atrium Health Wake Forest Baptist Medical Center /ID# 274847

Winston-Salem, North Carolina 27157

United States

Oncology Hematology Care - Blue Ash /ID# 272918

Cincinnati, Ohio 45252

United States

The Ohio State University /ID# 271336

Columbus, Ohio 43210

United States

University of Texas - Southwestern Medical Center /ID# 274360

Dallas, Texas 75235

United States

Huntsman Cancer Institute /ID# 272575

Salt Lake City, Utah 84112

United States

Coffs Harbour Health Campus /ID# 272010

Coffs Harbour, New South Wales 2450

Australia

Port Macquarie Base Hospital /ID# 275925

Port Macquarie, New South Wales 2444

Australia

Westmead Hospital /ID# 271880

Westmead, New South Wales 2145

Australia

Icon Cancer Care - South Brisbane /ID# 271836

South Brisbane, Queensland 4101

Australia

Royal Adelaide Hospital /ID# 272629

Adelaide, South Australia 5000

Australia

St Vincent's Hospital - Melbourne /ID# 276451

Fitzroy, Victoria 3065

Australia

Peter MacCallum Cancer Centre. /ID# 272024

Melbourne, Victoria 3000

Australia

The Perth Blood Institute - West Perth /ID# 272469

West Perth, Western Australia 6005

Australia

Rabin Medical Center. /ID# 271365

Petah Tikva, Central District 4941492

Israel

Soroka Medical Center /ID# 271367

Beersheba, Southern District 8410101

Israel

The Chaim Sheba Medical Center /ID# 271366

Ramat Gan, Tel Aviv 5265601

Israel

Rambam Health Care Campus- Haifa /ID# 271364

Haifa, 3109601

Israel

Hadassah Medical Center-Hebrew University /ID# 271362

Jerusalem, 91120

Israel

Nagoya City University Hospital /ID# 273529

Nagoya, Aichi-ken 467-8602

Japan

University Hospital Kyoto Prefectural University of Medicine /ID# 275713

Kyoto, Kyoto 602-8566

Japan

The University of Osaka Hospital /ID# 275791

Suita-shi, Osaka 565-0871

Japan

Oslo Universitetssykehus Ulleval /ID# 277915

Oslo, 0450

Norway

Hammersmith Hospital /ID# 274615

London, England W12 0HS

United Kingdom

University Hospitals Birmingham NHS Foundation Trust /ID# 274620

Birmingham, B15 2TG

United Kingdom

University Hospital of Wales /ID# 273446

Cardiff, CF14 4XW

United Kingdom