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
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
Interventions
Etentamig
Lenalidomide
Dexamethasone
Daratumumab
Dexamethasone
Carfilzomib
Mezigdomide
Iberdomide
ABBV-2001
Conditions
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