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RECRUITINGPhase 1 / Phase 2INTERVENTIONAL

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

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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. Who Should NOT Join This Trial: - Participant who has known active central nervous system involvement of MM. - Participant who has known active infection as outlined in the protocol. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

Etentamig

Intravenous (IV) Infusion

DRUG

Lenalidomide

Oral Capsule

DRUG

Dexamethasone

IV Injection

DRUG

Daratumumab

Subcutaneous Injection

DRUG

Dexamethasone

Oral Tablet

DRUG

Carfilzomib

IV Infusion

Locations (20)

Colorado Blood Cancer Institute /ID# 273129
Denver, Colorado, United States
Moffitt Cancer Center /ID# 272628
Tampa, Florida, United States
Winship Cancer Institute of Emory University /ID# 274830
Atlanta, Georgia, United States
Weill Cornell Medical College /ID# 272517
New York, New York, United States
University of North Carolina at Chapel Hill /ID# 274667
Chapel Hill, North Carolina, United States
Atrium Health Levine Cancer Institute /ID# 276193
Charlotte, North Carolina, United States
Atrium Health Wake Forest Baptist Medical Center /ID# 274847
Winston-Salem, North Carolina, United States
Oncology Hematology Care - Kenwood /ID# 272918
Cincinnati, Ohio, United States
Coffs Harbour Health Campus /ID# 272010
Coffs Harbour, New South Wales, Australia
Port Macquarie Base Hospital /ID# 275925
Port Macquarie, New South Wales, Australia
Westmead Hospital /ID# 271880
Westmead, New South Wales, Australia
Icon Cancer Care - South Brisbane /ID# 271836
South Brisbane, Queensland, Australia
Royal Adelaide Hospital /ID# 272629
Adelaide, South Australia, Australia
St Vincent's Hospital - Melbourne /ID# 276451
Fitzroy, Victoria, Australia
Peter MacCallum Cancer Centre /ID# 272024
Melbourne, Victoria, Australia
The Perth Blood Institute - West Perth /ID# 272469
West Perth, Western Australia, Australia
Soroka Medical Center /ID# 271367
Beersheba, Southern District, Israel
The Chaim Sheba Medical Center /ID# 271366
Ramat Gan, Tel Aviv, Israel
Rambam Health Care Campus- Haifa /ID# 271364
Haifa, Israel
Hadassah Medical Center-Hebrew University /ID# 271362
Jerusalem, Israel