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

Status: Recruiting
Location: See all (15) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Colorado
Colorado Blood Cancer Institute /ID# 273129
RECRUITING
Denver
North Carolina
University of North Carolina at Chapel Hill /ID# 274667
RECRUITING
Chapel Hill
Other Locations
Australia
Royal Adelaide Hospital /ID# 272629
RECRUITING
Adelaide
Coffs Harbour Health Campus /ID# 272010
RECRUITING
Coffs Harbour
Peter MacCallum Cancer Centre /ID# 272024
RECRUITING
Melbourne
Port Macquarie Base Hospital /ID# 275925
RECRUITING
Port Macquarie
Icon Cancer Care - South Brisbane /ID# 271836
RECRUITING
South Brisbane
The Perth Blood Institute - West Perth /ID# 272469
RECRUITING
West Perth
Westmead Hospital /ID# 271880
RECRUITING
Westmead
Israel
Rambam Health Care Campus /ID# 271364
RECRUITING
Haifa
Hadassah Medical Center-Hebrew University /ID# 271362
RECRUITING
Jerusalem
Rabin Medical Center /ID# 271365
RECRUITING
Petah Tikva
The Chaim Sheba Medical Center /ID# 271366
RECRUITING
Ramat Gan
Japan
University Hospital Kyoto Prefectural University of Medicine /ID# 275713
RECRUITING
Kyoto
The University of Osaka Hospital /ID# 275791
RECRUITING
Suita-shi
Contact Information
Primary
ABBVIE CALL CENTER
abbvieclinicaltrials@abbvie.com
844-663-3742
Time Frame
Start Date: 2025-06-30
Estimated Completion Date: 2036-03
Participants
Target number of participants: 440
Treatments
Experimental: Substudy 1: Etentamig Dose Escalation
Participants will receive escalating etentamig in combination with daratumumab, and lenalidomide (DR), as part of the approximately 130 month study duration.
Experimental: Substudy 1: Etentamig Dose Expansion Dose Level 1
Participants will receive dose level 1 of etentamig in combination with DR, as part of the approximately 130 month study duration.
Experimental: Substudy 1: Etentamig Dose Expansion Dose Level 2
Participants will receive dose level 2 of etentamig in combination with DR, as part of the approximately 130 month study duration.
Experimental: Substudy 1: Comparator
Participants will receive daratumumab, lenalidomide, and dexamethasone (DRd), as part of the approximately 130 month study duration.
Experimental: Substudy 2: Etentamig Dose Escalation
Participants will receive escalating etentamig, as part of the approximately 130 month study duration.
Experimental: Substudy 2: Etentamig Dose Expansion Dose Level 1
Participants will receive dose level 1 of etentamig, as part of the approximately 130 month study duration.
Experimental: Substudy 2: Etentamig Dose Expansion Dose Level 2
Participants will receive dose level 2 of etentamig, as part of the approximately 130 month study duration.
Experimental: Substudy 2: Comparator
Participants will receive lenalidomide (R), as part of the approximately 130 month study duration.
Experimental: Substudy 3: Etentamig Dose Escalation
Participants will receive escalating etentamig in combination with carfilzomib, and dexamethasone (Kd), as part of the approximately 130 month study duration.
Experimental: Substudy 3: Etentamig Dose Expansion Dose Level 1
Participants will receive dose level 1 of etentamig in combination with Kd, as part of the approximately 130 month study duration.
Experimental: Substudy 3: Etentamig Dose Expansion Dose Level 2
Participants will receive dose level 2 of etentamig in combination with Kd, as part of the approximately 130 month study duration.
Experimental: Substudy 3: Comparator
Participants will receive daratumumab, carfilzomib, and dexamethasone (DKd), as part of the approximately 130 month study duration.
Experimental: Substudy 4: Etentamig Dose Escalation
Participants will receive escalating etentamig in combination with R, as part of the approximately 130 month study duration.
Experimental: Substudy 4: Etentamig Dose Expansion Dose Level 1
Participants will receive dose level 1 of etentamig in combination with R, as part of the approximately 130 month study duration.
Experimental: Substudy 4: Etentamig Dose Expansion Dose Level 2
Participants will receive dose level 2 of etentamig in combination with R, as part of the approximately 130 month study duration.
Related Therapeutic Areas
Sponsors
Leads: AbbVie

This content was sourced from clinicaltrials.gov

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