A Study to Evaluate Adverse Events and Change in Disease Activity With Injected Etentamig Plus Oral Pomalidomide Versus Standard Therapies in Adults With Relapsed or Refractory Multiple Myeloma

Официальное название

A Phase 3, Multicenter, Randomized, Open Label Study to Evaluate the Safety and Efficacy of Etentamig in Combination With Pomalidomide Compared With Standard Available Therapies in Subjects With Relapsed or Refractory Multiple Myeloma (2L+ RRMM)

Обзор

Multiple myeloma (MM) is a plasma cell malignancy characterized by the proliferation of clonal plasma cells in the bone marrow. The disease primarily localizes to the bones and bone marrow, with resultant cytopenias, bone pain, fractures, infections, hypercalcemia, and renal failure. This study aims to evaluate the safety and change in disease activity of etentamig in combination with pomalidomide compared with standard available therapies in participants with relapsed or refractory multiple myeloma who have received 1-3 prior lines of treatment, including lenalidomide. Etentamig is an investigational drug being developed for the treatment of relapsed or refractory multiple myeloma. This is a randomized, open-label study. The study will include a safety run-in portion and a randomized portion. The safety run-in participants will receive etentamig in combination with pomalidomide. The randomized portion of the study participants will receive either etentamig with pomalidomide or Standard Available Therapies (SATs). Approximately 520 participants will be enrolled in the study at approximately 200 sites worldwide. Prior to initiation of the randomized portion of the study, the safety run-in will be conducted in which participants will receive etentamig injections plus oral pomalidomide. Following review of the safety run-in data and per protocol-defined criteria, the study will advance to the randomized portion where participants will be randomized to receive either etentamig injections plus oral pomalidomide or investigator's choice of SAT: SC daratumumab, oral pomalidomide, and oral/ IV dexamethasone (DPd); SC daratumumab, IV carfilzomib, and oral/IV dexamethasone (DKd); or SC teclistamab monotherapy. The total study duration is approximately 75 months There may be higher treatment burden for participants in this trial compared to their standard of care due to study procedures. Participants will attend regular visits during the study at a hospital or clinic. The effects of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Вмешательства

• Препарат Etentamig
  Injection
• Препарат Pomalidomide
  Oral
• Препарат Daratumumab
  Injection
• Препарат Dexamethasone
  Oral or Injection
• Препарат Carfilzomib
  Injection
• Препарат Teclistamab
  Injection

Первичные конечные точки

• Safety Run-In: Number of Participants With Adverse Events (AE)s [Срок оценки: Up to Approximately 75 Months]
• Randomized Portion: Complete Response (CR) or Better Rate Per Independent Review Committee (IRC) Assessment [Срок оценки: Up to Approximately 75 Months]
• Randomized Portion: Progression-Free Survival (PFS) Per Independent Review Committee (IRC) Assessment [Срок оценки: Up to Approximately 75 Months]

Вторичные конечные точки (12)

• Safety Run-In: Best Overall Response (BOR) of Per Investigator Assessment [Срок оценки: Up to Approximately 75 Months]
• Safety Run-In: Maximum Observed Concentration (Cmax) of Etentamig [Срок оценки: Up to Approximately 12 Months]
• Safety Run-In: Time to Cmax (Tmax) of Etentamig [Срок оценки: Up to Approximately 12 Months]
• Safety Run-In: Area under the Serum Concentration-Time Curve (AUC) of Etentamig [Срок оценки: Up to Approximately 12 Months]
• Safety Run-In: Immunogenicity of Etentamig [Срок оценки: Up to Approximately 75 Months]
• Randomized Portion: Minimal Residual Disease Negative Complete Response (MRDnegCR) Per IRC Assessment [Срок оценки: Up to Approximately 75 Months]
• Randomized Portion: Overall Survival (OS) [Срок оценки: Up to Approximately 75 Months]
• Randomized Portion: Sustained Minimal Residual Disease (MRD) Negativity [Срок оценки: Up to Approximately 75 Months]
• Randomized Portion: Best Minimal Residual Disease Negative Complete Response (MRD Negative CR) Per IRC Assessment [Срок оценки: Up to Approximately 75 Months]
• Randomized Portion: BOR Per IRC Assessment [Срок оценки: Up to Approximately 75 Months]
• Randomized Portion: VGPR or Better Rate Per IRC Assessment [Срок оценки: Up to Approximately 75 Months]
• Randomized Portion: Time to Response (TTR) Per IRC Assessment [Срок оценки: Up to Approximately 75 Months]

Критерии участия

Критерии включения

• Diagnosis of relapsed or refractory (RR) multiple myeloma (MM).
• Prior treatment with at least one and no more than three prior lines of therapy, including lenalidomide.
• Adequate organ function and performance status

Критерии исключения

• Prior B-cell maturation antigen (BCMA) directed T-cell engager therapy (bispecific or trispecific)
• Known central nervous system involvement of MM
• Known history of other active malignancies within the past 3 years (with specific exceptions)
• Clinically significant conditions (renal, neurologic, psychiatric, endocrine, metabolic, immunologic, cardiovascular, pulmonary, or hepatic disease within the last 6 months)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 24 центра

• University of Arizona Cancer Center /ID# 285339 — Tucson
• Toi Clinical Research - Whittier /ID# 284462 — Cerritos
• University of California Los Angeles /ID# 282444 — Los Angeles
• University Of Colorado - Anschutz Medical Campus /ID# 283478 — Aurora
• MedStar Georgetown University Hospital /ID# 283734 — Washington D.C.
• Cleveland Clinic Florida /ID# 283692 — Weston
• Northwest Georgia Oncology Centers /ID# 284769 — Marietta
• Rush University Medical Center /ID# 283095 — Chicago
• … и ещё 16 центров

Германия · 8 центров

• Universitaetsklinikum Freiburg /ID# 282874 — Freiburg im Breisgau
• Staedtisches Klinikum Karlsruhe /ID# 283569 — Karlsruhe
• Universitaetsklinikum Tuebingen /ID# 282873 — Tübingen
• Universitaetsklinikum Ulm /ID# 283884 — Ulm
• Universitaetsklinikum Wuerzburg /ID# 283572 — Würzburg
• Krh Klinikum Siloah-Oststadt-Heidehaus /ID# 283729 — Hanover
• Universitaetsklinikum Bonn /ID# 283881 — Bonn
• Universitaetsklinikum Koeln /ID# 283930 — Cologne

Австралия · 7 центров

• Wollongong Hospital. /ID# 282694 — Wollongong
• Pindara Private Hospital /ID# 283010 — Benowa
• Icon Cancer Care - South Brisbane /ID# 282965 — South Brisbane
• Peter MacCallum Cancer Centre. /ID# 282692 — Melbourne
• Epworth Hospital - Richmond /ID# 281877 — Richmond
• Fiona Stanley Hospital /ID# 281879 — Murdoch
• Sir Charles Gairdner Hospital /ID# 281881 — Nedlands

Великобритания · 6 центров

• University Hospitals Plymouth NHS Trust /ID# 283108 — Plymouth
• Western General Hospital - NHS Lothian /ID# 281838 — Edinburgh
• St Bartholomews Hospital - Barts Health /ID# 283714 — London
• Queen Alexandra Hospital /ID# 281839 — Portsmouth
• NHS Lanarkshire /ID# 282021 — Airdrie
• Nottingham City Hospital /ID# 282748 — Nottingham

Франция · 5 центров

• Chu de Nice-Hopital Larchet Ii /Id# 283541 — Nice
• CHRU Tours - Hopital Bretonneau /ID# 281925 — Tours
• Centre Hospitalier Regional Universitaire de Nancy - Hopitaux de Brabois /ID# 284303 — Vandœuvre-lès-Nancy
• Centre Hospitalier Universitaire de Nantes - L' Hopital l'hotel-Dieu /ID# 282025 — Nantes
• Centre Hospitalier d'Avignon /ID# 283509 — Avignon

Португалия · 4 центра

• Centro Hospitalar De Lisboa Ocidental - Hospital De Sao Francisco Xavier /ID# 283500 — Lisbon
• Unidade Local de Saude de Gaia/Espinho /ID# 283492 — Vila Nova de Gaia
• 2CA-Braga, Hospital de Braga /ID# 283828 — Braga
• Unidade Local de Saude Sao Joao /ID# 283530 — Porto

Канада · 3 центра

• British Columbia Cancer Agency Vancouver Centre /ID# 282147 — Victoria
• London Health Sciences Centre - Victoria Hospital & Children's Hospital /ID# 282149 — London
• Universite de Montreal - Hopital Maisonneuve-Rosemont /ID# 281705 — Montreal

Испания · 3 центра

• Hospital Universitario Marques de Valdecilla /ID# 283344 — Santander
• Clinica Universidad de Navarra - Pamplona /ID# 283290 — Pamplona
• Hospital General Universitario Gregorio Maranon /ID# 283342 — Madrid

Нидерланды · 2 центра

• Leids Universitair Medisch Centrum /ID# 283142 — Leiden
• Erasmus Medisch Centrum /ID# 283408 — Rotterdam

Венгрия · 1 центр

• Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz /ID# 283136 — Szombathely

Италия · 1 центр

• Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST - IRCCS /ID# 281398 — Meldola

Норвегия · 1 центр

• Haukeland University Hospital /ID# 283524 — Bergen

Тайвань · 1 центр

• Kaohsiung Chang Gung Memorial Hospital /ID# 282970 — Kaohsiung City

Идентификаторы

NCT: NCT07728188 · M22-538 · 2026-525596-11-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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