Actively Recruiting
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
Led by AbbVie · Updated on 2026-02-17
440
Participants Needed
25
Research Sites
556 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Eastern cooperative oncology group (ECOG) performance of <= 1
- Confirmed diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) criteria
- Participants with newly diagnosed or relapsed or refractory multiple myeloma depending on substudy
You will not qualify if you...
- Known active central nervous system involvement of multiple myeloma
- Known active infection as detailed in the protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 25 locations
1
Colorado Blood Cancer Institute /ID# 273129
Denver, Colorado, United States, 80218
Actively Recruiting
2
Moffitt Cancer Center /ID# 272628
Tampa, Florida, United States, 33612
Actively Recruiting
3
Winship Cancer Institute of Emory University /ID# 274830
Atlanta, Georgia, United States, 30322
Actively Recruiting
4
Weill Cornell Medical College /ID# 272517
New York, New York, United States, 10065
Actively Recruiting
5
University of North Carolina at Chapel Hill /ID# 274667
Chapel Hill, North Carolina, United States, 27514
Actively Recruiting
6
Atrium Health Levine Cancer Institute /ID# 276193
Charlotte, North Carolina, United States, 28204-2990
Actively Recruiting
7
Atrium Health Wake Forest Baptist Medical Center /ID# 274847
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
8
Oncology Hematology Care - Kenwood /ID# 272918
Cincinnati, Ohio, United States, 45236
Actively Recruiting
9
Coffs Harbour Health Campus /ID# 272010
Coffs Harbour, New South Wales, Australia, 2450
Actively Recruiting
10
Port Macquarie Base Hospital /ID# 275925
Port Macquarie, New South Wales, Australia, 2444
Actively Recruiting
11
Westmead Hospital /ID# 271880
Westmead, New South Wales, Australia, 2145
Actively Recruiting
12
Icon Cancer Care - South Brisbane /ID# 271836
South Brisbane, Queensland, Australia, 4101
Actively Recruiting
13
Royal Adelaide Hospital /ID# 272629
Adelaide, South Australia, Australia, 5000
Actively Recruiting
14
St Vincent's Hospital - Melbourne /ID# 276451
Fitzroy, Victoria, Australia, 3065
Actively Recruiting
15
Peter MacCallum Cancer Centre /ID# 272024
Melbourne, Victoria, Australia, 3000
Actively Recruiting
16
The Perth Blood Institute - West Perth /ID# 272469
West Perth, Western Australia, Australia, 6005
Actively Recruiting
17
Soroka Medical Center /ID# 271367
Beersheba, Southern District, Israel, 8410101
Actively Recruiting
18
The Chaim Sheba Medical Center /ID# 271366
Ramat Gan, Tel Aviv, Israel, 5265601
Actively Recruiting
19
Rambam Health Care Campus- Haifa /ID# 271364
Haifa, Israel, 3525408
Actively Recruiting
20
Hadassah Medical Center-Hebrew University /ID# 271362
Jerusalem, Israel, 91120
Actively Recruiting
21
Rabin Medical Center. /ID# 271365
Petah Tikva, Israel, 4941492
Actively Recruiting
22
Nagoya City University Hospital /ID# 273529
Nagoya, Aichi-ken, Japan, 467-8602
Actively Recruiting
23
University Hospital Kyoto Prefectural University of Medicine /ID# 275713
Kyoto, Kyoto, Japan, 602-8566
Actively Recruiting
24
The University of Osaka Hospital /ID# 275791
Suita-shi, Osaka, Japan, 565-0871
Actively Recruiting
25
Hammersmith Hospital /ID# 274615
London, England, United Kingdom, W12 0HS
Actively Recruiting
Research Team
A
ABBVIE CALL CENTER
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
15
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