Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
NCT06892522

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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