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RECRUITING Phase 2 / Phase 3 ClinicalTrials.gov

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

Sponsor: AbbVie • ClinicalTrials.gov ID: NCT07095452

Registry updated: 2026-10-19
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Description

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; a phase 2 dose selection and optimization cohort with 3 study arms and a subcutaneous (SC) safety cohort with 2 study arms. Phase 3 participants will receive etentamig at recommended Phase 3 dose (RP3D). Around 680 adult participants with MM will be enrolled at approximately 155 sites worldwide Participants in the phase 2 dose selection and optimization cohort will receive 1 of 3 doses of etentamig as intravenous (IV) infusions, combination with subcutaneous (SC) injections of daratumumab. The Phase 2 subcutaneous (SC) safety cohort participants will receive 1 of 2 doses of etentamig in combination with 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.

Interventions

  • Etentamig (Drug)
    Intravenous (IV) Infusion
  • Lenalidomide (Drug)
    Oral Capsule
  • Daratumumab (Drug)
    Subcutaneous Injection
  • Dexamethasone (Drug)
    Oral Tablet
  • Dexamethasone (Drug)
    IV Injection
  • Etentamig (Drug)
    Subcutaneous Injection

Eligibility criteria

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.

Conditions

Multiple Myeloma

Locations

  • Mayo Clinic Hospital Scottsdale /ID# 278349 — Scottsdale, Arizona, United States
  • Cedars-Sinai Medical Center /ID# 278238 — Los Angeles, California, United States
  • Colorado Blood Cancer Institute /ID# 279080 — Denver, Colorado, United States
  • Winship Cancer Institute of Emory University /ID# 277667 — Atlanta, Georgia, 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
  • Icahn School of Medicine at Mount Sinai /ID# 277844 — New York, New York, United States
  • Memorial Sloan Kettering Cancer Center - New York - York Avenue /ID# 277946 — New York, New York, United States
  • Weill Cornell Medicine Myeloma Center /ID# 278216 — 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
  • Centre Hospitalier De Dunkerque-Hospital Alexandra Lepeve /ID# 278399 — Dunkirk, Hauts-de-France, 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
  • CH Bretagne Atlantique /ID# 278422 — Vannes, Morbihan, France
  • Centre Hospitalier Universitaire de Bordeaux /ID# 278419 — Pessac, New Aquitaine, France
  • Centre Hospitalier Universitaire de Poitiers /ID# 278398 — Poitiers, New 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
  • Centre Hospitalier Universitaire de Saint Etienne - Hopital Nord /ID# 278421 — St-Priest-en-Jarez, Pays de la Loire Region, France
  • HCL - Hopital Lyon Sud /ID# 282145 — Pierre-Bénite, Rhone, France
  • Hopital Saint-Louis /ID# 278429 — Paris, France
  • Hopital Saint Antoine /ID# 278428 — Paris, France
  • Hopital Universitaire Necker Enfants Malades /ID# 278426 — Paris, Île-de-France Region, France
  • Nagoya City University Hospital /ID# 278188 — Nagoya, Aichi-ken, Japan
  • Matsuyama Red Cross Hospital /ID# 278660 — Matsuyama, Ehime, Japan
  • Kurume University Hospital /ID# 278209 — Kurume-shi, Fukuoka, Japan
  • Tokai University Hospital /ID# 278157 — Isehara, Kanagawa, Japan
  • University Hospital Kyoto Prefectural University of Medicine /ID# 278156 — Kyoto, Kyoto, Japan
  • Complejo Hospitalario Universitario de Santiago /ID# 278531 — Santiago de Compostela, A Coruna, Spain
  • Institut Catala d Oncologia - ICO - Badalona /ID# 278522 — Badalona, Barcelona, Spain
  • Hospital Universitario Marques de Valdecilla /ID# 278535 — Santander, Cantabria, Spain
  • Hospital Universitario de Gran Canaria Doctor Negrin /ID# 278527 — Las Palmas de Gran Canaria, Las Palmas, Spain
  • Clinica Universidad de Navarra - Pamplona /ID# 278583 — Pamplona, Navarre, Spain
  • Hospital Clinic de Barcelona /ID# 278532 — Barcelona, Spain
  • Complejo Asistencial Universitario de Leon - Hospital de Leon /ID# 278534 — León, Spain
  • Hospital General Universitario Gregorio Maranon /ID# 278551 — Madrid, Spain
  • Hospital Universitario Ramon y Cajal /ID# 278533 — Madrid, Spain
  • Hospital Universitario 12 de Octubre /ID# 278520 — Madrid, Spain
  • Hospital Universitario de Salamanca /ID# 278530 — Salamanca, Spain
  • Hospital Universitari i Politecnic La Fe /ID# 278525 — Valencia, Spain
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record