Study of Intravenously (IV) Infused Etentamig in Combination With an Oral Cereblon E3 Ligase Modulatory Drug (CELMoD) Agent Assessing Adverse Events and Change in Disease Activity in Adult Participants With Relapsed or Refractory Multiple Myeloma

Официальное название

Phase 1/2 Study of Etentamig in Combination With a CELMoD Agent for the Treatment of Patients With Relapsed/Refractory Multiple Myeloma

Обзор

Multiple myeloma (MM) is a plasma cell disease characterized by the growth of clonal plasma cells in the bone marrow. The purpose of this study is to assess the adverse events and change in disease activity of etentamig in combination with a cereblon E3 ligase modulatory drug (CELMoD) agent in adult participants with relapsed/refractory (R/R) multiple myeloma (MM). Adverse events and change in disease state will be assessed. Etentamig is an investigational drug being developed for the treatment of R/R MM. Study doctors put the participants in groups called treatment arms. Multiple doses of etentamig in combination with iberdomide will be explored. Each treatment arm receives a different dose of etentamig and iberdomide to determine a tolerable dose. Approximately 135 adult participants with R/R MM will be enrolled in the study in approximately 50 sites worldwide. In phase 1 participants will receive escalating intravenous (IV) etentamig in combination with oral iberdomide. In phase 2 participants will receive IV etentamig at one of two doses in combination with oral iberdomide, as part of the approximately 129 month study duration. 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 an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and and monitoring of side effects.

Подробное описание

B-cell maturation antigen (BCMA) chimeric antigen receptor T-cell (CAR-T) or BCMA antibody-drug conjugate (ADC) are allowed.

Вмешательства

• Препарат Etentamig
  Intravenous (IV) Infusion
• Препарат Iberdomide
  Oral Capsule

Первичные конечные точки

• Phase 1: Dose-Limiting Toxicities (DLT)s of Etentamig when given in Combination with Iberdomide in Participants with Relapsed/Refractory Multiple Myeloma (RRMM) [Срок оценки: Up to Approximately 56 Days]
• Number of Participants with Adverse Events (AE)s [Срок оценки: Up to Approximately 129 Months]

Вторичные конечные точки (9)

• Partial Response (PR) Response Rate (RR) [Срок оценки: Up to 3 Years]
• Very Good Partial Response (VGPR) RR [Срок оценки: Up to 3 Years]
• Complete Response (CR) RR [Срок оценки: Up to 3 Years]
• Stringent Complete Response (sCR) RR [Срок оценки: Up to 3 Years]
• Overall Response Rate (ORR) [Срок оценки: Up to 3 Years]
• Progression-Free Survival (PFS) [Срок оценки: Up to 3 Years]
• Duration of Response (DOR) [Срок оценки: Up to 3 Years]
• Time-to-Progression (TTP) [Срок оценки: Up to 3 Years]
• Minimal Residual Disease (MRD) negativity [Срок оценки: Up to 3 Years]

Критерии участия

Критерии включения

• Eastern Cooperative Oncology Group (ECOG) performance of 0 or 1.
• Must have confirmed diagnosis of Relapsed/Refractory Multiple Myeloma (RRMM) after the participant's last treatment, as outlined in the protocol.
• All participants must have measurable diseases per central laboratory as outlined in protocol

Критерии исключения

• Has received prior etentamig treatment.
• Prior exposure to BCMA-targeted therapy as noted in the protocol.
• Has received prior cereblon E3 ligase modulatory drug (CELMoD) (iberdomide or mezigdomide).

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 7 центров

• Beverly Hills Cancer Center /ID# 266921 — Beverly Hills
• Colorado Blood Cancer Institute /ID# 273751 — Denver
• Washington University /ID# 266972 — St Louis
• Rutgers Cancer Institute of New Jersey /ID# 266833 — New Brunswick
• Memorial Sloan Kettering Cancer Center - New York - York Avenue /ID# 270282 — New York
• University Of North Carolina Health Care - Hillsborough Campus /ID# 278230 — Hillsborough
• Swedish Medical Center - Seattle /ID# 268052 — Seattle

Австралия · 5 центров

• Blacktown Hospital /ID# 265983 — Blacktown
• Wollongong Hospital /ID# 265625 — Wollongong
• The Alfred Hospital /ID# 265981 — Melbourne
• Austin Hospital /ID# 265984 — Melbourne
• Sir Charles Gairdner Hospital /ID# 265985 — Nedlands

Франция · 5 центров

• Chu de Nice-Hopital Larchet Ii /Id# 266845 — Nice
• Hôpital La Timone /ID# 267053 — Marseille
• Chu De Lille - Hopital Claude Huriez /ID# 270193 — Lille
• Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau /ID# 267694 — Tours
• IUCT Oncopole /ID# 266391 — Toulouse

Япония · 5 центров

• National Cancer Center Hospital East /ID# 268343 — Kashiwa-shi
• Kumamoto University Hospital /ID# 270530 — Kumamoto
• Dokkyo Medical University Hospital /ID# 271648 — Mibu
• Nippon Medical School Hospital /ID# 270254 — Bunkyo-ku
• The Cancer Institute Hospital Of JFCR /ID# 268342 — Koto-ku

Канада · 2 центра

• University Health Network_Princess Margaret Cancer Centre /ID# 275636 — Toronto
• Jewish General Hospital /ID# 267574 — Montreal

Нидерланды · 2 центра

• Amsterdam UMC, Location VUmc /ID# 267670 — Amsterdam
• Universitair Medisch Centrum Utrecht /ID# 267660 — Utrecht

Норвегия · 1 центр

• Oslo Universitetssykehus Ulleval /ID# 275433 — Oslo

Идентификаторы

NCT: NCT06896916 · M24-555 · 2024-512146-41-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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