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RECRUITINGPhase 2 / Phase 3INTERVENTIONAL

A Study to Assess A Change in Disease Activity and Adverse Events of Intravenous Etentamig and Daratumumab (Etentamig+D) Compared to Daratumumab, Lenalidomide, and Dexamethasone (DRd) in Adult Participants With Newly Diagnosed Multiple Myeloma Not Eligible for Transplant

Phase 2/3, Multicenter, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Etentamig and Daratumumab (Etentamig+D) Compared to Daratumumab, Lenalidomide, and Dexamethasone (DRd) in Subjects With Newly Diagnosed Multiple Myeloma Not Eligible for Transplant

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. This is a study to determine the adverse events, change in disease activity, 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 2 phases; phase 2 with 3 study arms and phase 3 with 2 study arms. Participants in phase 2 will receive 1 of 3 doses of etentamig in combination with daratumumab. Participants in phase 3 will receive etentamig at RP3D in combination with daratumumab, or daratumumab, lenalidomide, and dexamethasone (DRd). Around 660 adult participants with MM will be enrolled at approximately 155 sites worldwide Participants in phase 2 will receive 1 of 3 doses of etentamig as intravenous (IV) infusions, combination with subcutaneous (SC) injections of daratumumab. Participants in phase 3 will receive RP3D doses of etentamig as IV infusions, combination with SC injections of daratumumab, or SC injections of daratumumab, capsules of lenalidomide, and tablet/ IV injections of dexamethasone (DRd). The study duration is approximately 16 years. 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: - Participants must have confirmed new diagnosis of multiple myeloma (NDMM) according to the International Myeloma Working Group (IMWG) diagnostic criteria, and per investigator's judgement, participant is not suitable to receive high-dose chemotherapy and stem cell transplantation due to factors likely to have a negative impact on tolerability of high dose chemotherapy and autologous stem cell transplants (ASCT). - IMWG Myeloma Frailty Index Score of \>= 1 - All participants must have measurable disease per central laboratory with at least 1 of the following assessed within 28 days prior to enrollment: - Serum M-protein \>= 0.5 g/dL (\>= 5 g/L). - Urine M-protein \>= 200 mg/24 hours. - Serum free light chain (FLC) \>= 100 mg/L (\>= 10 mg/dL) (involved light chain) and an abnormal serum kappa lambda ratio only for participants without measurable serum or urine M-protein. Who Should NOT Join This Trial: - Prior or current systemic therapy or stem cell transplant (SCT) for multiple myeloma or any plasma cell dyscrasia other than short course of corticosteroids - Participant treated with any investigational treatment within 30 days or 5 half-lives of the treatment (whichever is longer) prior to the first dose of study treatment or is currently enrolled in another clinical study - Participant who has known active central nervous system involvement of MM. - Participant who has history of clinically significant renal, neurologic, psychiatric, endocrine, metabolic, immunologic, pulmonary, or hepatic disease within the last 6 months that, in the investigator's opinion, would adversely affect the participant's participation in the study. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Participants must have confirmed new diagnosis of multiple myeloma (NDMM) according to the International Myeloma Working Group (IMWG) diagnostic criteria, and per investigator's judgement, participant is not suitable to receive high-dose chemotherapy and stem cell transplantation due to factors likely to have a negative impact on tolerability of high dose chemotherapy and autologous stem cell transplants (ASCT). * IMWG Myeloma Frailty Index Score of \>= 1 * All participants must have measurable disease per central laboratory with at least 1 of the following assessed within 28 days prior to enrollment: * Serum M-protein \>= 0.5 g/dL (\>= 5 g/L). * Urine M-protein \>= 200 mg/24 hours. * Serum free light chain (FLC) \>= 100 mg/L (\>= 10 mg/dL) (involved light chain) and an abnormal serum kappa lambda ratio only for participants without measurable serum or urine M-protein. Exclusion Criteria: * Prior or current systemic therapy or stem cell transplant (SCT) for multiple myeloma or any plasma cell dyscrasia other than short course of corticosteroids * Participant treated with any investigational treatment within 30 days or 5 half-lives of the treatment (whichever is longer) prior to the first dose of study treatment or is currently enrolled in another clinical study * Participant who has known active central nervous system involvement of MM. * Participant who has history of clinically significant renal, neurologic, psychiatric, endocrine, metabolic, immunologic, pulmonary, or hepatic disease within the last 6 months that, in the investigator's opinion, would adversely affect the participant's participation in the study.

Treatments Being Tested

DRUG

Etentamig

Intravenous (IV) Infusion

DRUG

Lenalidomide

Oral Capsule

DRUG

Daratumumab

Subcutaneous Injection

DRUG

Dexamethasone

Oral Tablet

DRUG

Dexamethasone

IV Injection

Locations (20)

Mayo Clinic Hospital Scottsdale /ID# 278349
Scottsdale, Arizona, United States
Colorado Blood Cancer Institute /ID# 279080
Denver, Colorado, United States
Fort Wayne Medical Oncology And Hematology /ID# 278141
Fort Wayne, Indiana, United States
Minnesota Oncology - Minneapolis Clinic /ID# 278720
Minneapolis, Minnesota, United States
Mayo Clinic Hospital Rochester /ID# 277886
Rochester, Minnesota, United States
Memorial Sloan Kettering Cancer Center - New York - York Avenue /ID# 277946
New York, New York, United States
University of North Carolina at Chapel Hill /ID# 277708
Chapel Hill, North Carolina, United States
Willamette Valley Cancer Institute and Research Center /ID# 278721
Eugene, Oregon, United States
SCRI Oncology Partners /ID# 278353
Nashville, Tennessee, United States
Texas Oncology - The Woodlands /ID# 278726
The Woodlands, Texas, United States
Texas Oncology - Northeast Texas /ID# 278725
Tyler, Texas, United States
Virginia Cancer Specialists - Fairfax /ID# 278716
Fairfax, Virginia, United States
Blue Ridge Cancer Care - Roanoke /ID# 278722
Roanoke, Virginia, United States
Centre Hospitalier Annecy Genevois /ID# 278406
Epagny Metz Tessy, Auvergne-Rhône-Alpes, France
Chu De Lille - Hopital Claude Huriez /ID# 278413
Lille, Hauts-de-France, France
CHU de Montpellier - Hopital Saint Eloi /ID# 278415
Montpellier, Herault, France
CHRU Tours - Hopital Bretonneau /ID# 279274
Tours, Indre-et-Loire, France
Centre Hospitalier Universitaire de Bordeaux /ID# 278419
Pessac, Nouvelle-Aquitaine, France
IUCT Oncopole /ID# 278403
Toulouse, Occitanie, France
Centre Hospitalier Universitaire de Nantes, Hotel Dieu -HME /ID# 278402
Nantes, Pays de la Loire Region, France