A Study to Assess Change in Disease Activity and Adverse Events (AE)s in Adult Participants With Multiple Myeloma Receiving T Cell Engaging Bi/Tri-specific Antibodies Intravenously (IV)/Subcutaneously (SC) Alone or in Combinations

Официальное название

A Phase 1/2, Open-Label, Platform Study to Evaluate Safety and Efficacy of T Cell Engaging Bi/Tri-specific Antibodies in Subjects With MM

Обзор

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 and ABBV-2001 in adult participants with MM. Etentamig and ABBV-2001 are investigational drugs being developed for the treatment of MM. This study is broken into 6 substudies and each substudy consists of a dose escalation phase and dose expansion phase. Participants in substudies 1-4 will receive escalating doses of etentamig alone or with daratumumab and lenalidomide (DR), carfilzomib and dexamethasone (Kd) or lenalidomide (R), followed by etentamig at the dose levels established during the escalation phases alone or with DR, Kd, R. Participants in substudies 1-4 can also receive daratumumab, lenalidomide and dexamethasone (DRd), R, or daratumumab, carfilzomib, and dexamethasone (DKd) as a comparator in the dose expansion phases. Participants in substudies 5-6 will receive escalating doses or at the dose levels established during the escalation phases of ABBV-2001 with iberdomide or mezigdomide. Around 602 adult participants with MM will be enrolled at approximately 75 sites worldwide In substudies 1-3, participants will receive escalating doses of etentamig as Intravenous (IV) infusions, alone or with DR, R or Kd, followed by IV infusions of etentamig at the dose levels established during the escalation phases alone or with IV and DRd, DKd, or R. In substudie 4, participants will receive escalating doses of etentamig as Intravenous (IV) infusions followed by IV infusions of etentamig at the dose levels established during the escalation phase. In substudies 5-6, participants will receive escalating doses of ABBV-2001 as subcutaneous (SC) injections, with oral iberdomide or mezigdomide, followed by SC injections of ABBV-2001 at the dose levels established during the escalation phases with oral iberdomide or mezigdomide. 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.

Вмешательства

• Препарат Etentamig
  Intravenous (IV) Infusion
• Препарат Lenalidomide
  Oral
• Препарат Dexamethasone
  IV Injection
• Препарат Daratumumab
  Subcutaneous Injection
• Препарат Dexamethasone
  Oral
• Препарат Carfilzomib
  IV Infusion
• Препарат Mezigdomide
  Oral
• Препарат Iberdomide
  Oral
• Препарат ABBV-2001
  subcutaneous (SC) Injection

Первичные конечные точки

• Number of Participants with Adverse Events (AE)s [Срок оценки: Up to Approximately 130 Months]
• Substudy 1: Dose-Limiting Toxicity (DLT) of Etentamig + Daratumumab and Lenalidomide (DR) in Participants with Transplant-Ineligible Newly Diagnosed Multiple Myeloma (TI NDMM) [Срок оценки: Up to Approximately 8 weeks]
• Substudy 2: DLT of Etentamig Monotherapy as Maintenance in Participants with Transplant-Eligible Newly Diagnosed Multiple Myeloma (TE NDMM) [Срок оценки: Up to Approximately 8 Weeks]
• Substudy 3: DLT of Etentamig +Carfilzomib and Dexamethasone (Kd) Combination in Participants with Relapsed or Refractory Multiple Myeloma (RR MM) [Срок оценки: Up to Approximately 8 Weeks]
• Substudy 4: DLT of Etentamig plus Lenalidomide when Given as Maintenance in Participants with TE NDMM [Срок оценки: Up to Approximately 8 Weeks]
• Substudy 5: DLT of ABBV-2001 in Combination with Iberdomide in Participants with RR MM [Срок оценки: Up to Approximately 8 Weeks]
• Substudy 6: DLT of ABBV-2001 in Combination with Mezigdomide in Participants with RR MM [Срок оценки: Up to Approximately 8 Weeks]

Вторичные конечные точки (6)

• Substudy 1, 2, 3, 4, 5, 6: Complete Response Rate [Срок оценки: Up to Approximately 1 Year]
• Substudy 1, 2, 3, 4, 5, 6: Overall Response Rate (ORR) [Срок оценки: Up to Approximately 1 Year]
• Substudy 1, 2, 3, 4, 5, 6: Progression Free Survival (PFS) [Срок оценки: Up to Approximately 130 Months]
• Substudy 1, 2, 3, 4, 5, 6: Duration of Response (DOR) [Срок оценки: Up to Approximately 130 Months]
• Substudy 1, 2, 3, 4, 5, 6: Time-to-Progression (TTP) [Срок оценки: Up to Approximately 130 Months]
• Substudy 1, 2, 3, 4, 5, 6: Minimal Residual Disease (MRD) negativity [Срок оценки: Up to Approximately 52 Weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• Participant who has known active central nervous system involvement of MM.
• Participant who has known active infection as outlined in the protocol.

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 · 14 центров

• City of Hope National Medical Center /ID# 273132 — Duarte
• City of Hope - Orange County Lennar Foundation Cancer Center /ID# 277911 — Irvine
• Colorado Blood Cancer Institute /ID# 273129 — Denver
• Moffitt Cancer Center /ID# 272628 — Tampa
• Winship Cancer Institute of Emory University /ID# 274830 — Atlanta
• Mount Sinai - The Tisch Cancer Institute /ID# 272470 — New York
• Weill Cornell Medical College /ID# 272517 — New York
• University of North Carolina at Chapel Hill /ID# 274667 — Chapel Hill
• … и ещё 6 центров

Австралия · 8 центров

• Coffs Harbour Health Campus /ID# 272010 — Coffs Harbour
• Port Macquarie Base Hospital /ID# 275925 — Port Macquarie
• Westmead Hospital /ID# 271880 — Westmead
• Icon Cancer Care - South Brisbane /ID# 271836 — South Brisbane
• Royal Adelaide Hospital /ID# 272629 — Adelaide
• St Vincent's Hospital - Melbourne /ID# 276451 — Fitzroy
• Peter MacCallum Cancer Centre. /ID# 272024 — Melbourne
• The Perth Blood Institute - West Perth /ID# 272469 — West Perth

Израиль · 5 центров

• Rabin Medical Center. /ID# 271365 — Petah Tikva
• Soroka Medical Center /ID# 271367 — Beersheba
• The Chaim Sheba Medical Center /ID# 271366 — Ramat Gan
• Rambam Health Care Campus- Haifa /ID# 271364 — Haifa
• Hadassah Medical Center-Hebrew University /ID# 271362 — Jerusalem

Япония · 3 центра

• Nagoya City University Hospital /ID# 273529 — Nagoya
• University Hospital Kyoto Prefectural University of Medicine /ID# 275713 — Kyoto
• The University of Osaka Hospital /ID# 275791 — Suita-shi

Великобритания · 3 центра

• Hammersmith Hospital /ID# 274615 — London
• University Hospitals Birmingham NHS Foundation Trust /ID# 274620 — Birmingham
• University Hospital of Wales /ID# 273446 — Cardiff

Норвегия · 1 центр

• Oslo Universitetssykehus Ulleval /ID# 277915 — Oslo

Идентификаторы

NCT: NCT06892522 · M25-059 · 2024-515770-27-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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