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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

RecruitingPhase 2, Phase 3Ages 18 Years - anyAllAbbVie
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In plain words

What the trial is, and whether it could suit you

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 etenta

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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.
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What it tests

  • Etentamig
  • Lenalidomide
  • Daratumumab
  • Dexamethasone
  • Dexamethasone
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Where

49 sites
Mayo Clinic Hospital Scottsdale /ID# 278349
Scottsdale, United States
Cedars-Sinai Medical Center /ID# 278238
Los Angeles, United States
Colorado Blood Cancer Institute /ID# 279080
Denver, United States
Winship Cancer Institute of Emory University /ID# 277667
Atlanta, United States
Fort Wayne Medical Oncology And Hematology /ID# 278141
Fort Wayne, United States
Minnesota Oncology - Minneapolis Clinic /ID# 278720
Minneapolis, United States
Mayo Clinic Hospital Rochester /ID# 277886
Rochester, United States
Icahn School of Medicine at Mount Sinai /ID# 277844
New York, United States

โ€ฆand 41 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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