A Study Evaluating the Safety, Pharmacokinetics, and Activity of the Combination of Cevostamab and Elranatamab in Participants With Relapsed or Refractory Multiple Myeloma (R/R MM)

Официальное название

An Open-Label, Multicenter, Phase Ib Trial Evaluating the Safety, Pharmacokinetics, and Activity of the Combination of Cevostamab and Elranatamab in Patients With Relapsed or Refractory Multiple Myeloma

Обзор

The purpose of the study is to evaluate safety and tolerability of the combination of cevostamab plus elranatamab and also determine the recommended Phase II regimen (RP2R) for the study treatment. The study consists of a safety lead-in stage, and an expansion stage.

Вмешательства

• Препарат Cevostamab
  Cevostamab solution for infusion will be administered as IV as specified in each treatment arm.
• Препарат Elranatamab
  Elranatamab solution for injection will be administered SC as specified in each treatment arm.
• Препарат Tocilizumab
  Tocilizumab will be used as rescue medication for participants who experience a cytokine release syndrome (CRS) event.

Первичные конечные точки

• Number of Participants With Adverse Events (AEs) [Срок оценки: From signing of informed consent up to end of study (EOS) (approximately 36 months)]
• Recommended Phase II Regimen (RP2R) [Срок оценки: Up to approximately 36 months]

Вторичные конечные точки (12)

• Objective Response Rate (ORR) as Determined by the Investigator per International Myeloma Working Group (IMWG) Criteria [Срок оценки: Up to approximately 36 months]
• Complete Response (CR)/ Stringent Complete Response (sCR) Rate as Determined by the Investigator per IMWG Criteria [Срок оценки: Up to approximately 36 months]
• Rate of Very Good Partial Response (VGPR) or Better, as Determined by the Investigator per IMWG Criteria [Срок оценки: Up to approximately 36 months]
• Progression-Free Survival as Determined by the Investigator per IMWG Criteria [Срок оценки: Up to approximately 36 months]
• Duration of Response (DOR) as Determined by the Investigator (for Participants who Achieve a Response of Partial Response (PR) or Better) [Срок оценки: Up to approximately 36 months]
• Time to First Response (for Participants who Achieve a Response of PR or Better) [Срок оценки: Up to approximately 36 months]
• Time to Best Response (for Participants who Achieve a Response of PR or Better) [Срок оценки: Up to approximately 36 months]
• Overall Survival (OS) [Срок оценки: Up to approximately 36 months]
• Serum Concentration of Cevostamab at Specified Timepoints [Срок оценки: Up to approximately 36 months]
• Serum Concentration of Elranatamab at Specified Timepoints [Срок оценки: Up to approximately 36 months]
• Number of Participants with Anti-Drug Antibody (ADA) Against Cevostamab [Срок оценки: Up to approximately 36 months]
• Number of Participants with ADA Against Elranatamab [Срок оценки: Up to approximately 36 months]

Критерии участия

Критерии включения

• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
• Diagnosis of R/R MM per IMWG criteria
• For female participants of childbearing potential: agreement to remain abstinent or use contraception
• For male participants: agreement to remain abstinent or use a condom

Критерии исключения

• Prior treatment with cevostamab or another agent targeting fragment crystallizable receptor-like 5 (FcRH5)
• Prior treatment with elranatamab
• Prior allogeneic stem cell transplantation (SCT)
• Absolute plasma cell count exceeding 500 per milliliter (mL) or 5% of the peripheral blood white cells
• Diagnosis of Waldenström macroglobulinemia or polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, skin changes (POEMS) syndrome
• Participants with known history of amyloidosis
• History of autoimmune disease
• History of confirmed progressive multifocal leukoencephalopathy
• Peripheral motor polyneuropathy of prespecified grade
• Known or suspected chronic cytomegalovirus (CMV) and/or Epstein-Barr virus (EBV) infection
• Known history of hemophagocytic lymphohistiocytosis (HLH) or macrophage activation syndrome (MAS)
• Acute or chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
• Human immunodeficiency virus (HIV) seropositivity
• History of central nervous system (CNS) myeloma disease
• Significant cardiovascular disease

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Австралия · 5 центров

• Royal Prince Alfred Hospital — Camperdown
• Calvary Mater Newcastle — Waratah
• Royal Adelaide Hospital;Haematology Clinical Trials Unit — Adelaide
• St. Vincent's Hospital Melbourne — Melbourne
• The Alfred Hospital — Prahan

South Korea · 5 центров

• The Catholic University of Korea - Seoul St. Mary's Hospital (Kangnam St. Mary's Hospital) — Seocho
• Seoul National University Hospital — Seoul
• Severance Hospital, Yonsei University Health System — Seoul
• Asan Medical Center. — Seoul
• Samsung Medical Center - PPDS — Seoul

Израиль · 4 центра

• The Chaim Sheba Medical Center - PPDS — Ramat Gan
• Rambam Health Care Campus — Haifa
• Hadassah University Hospital - Ein Kerem — Jerusalem
• Tel Aviv Sourasky Medical Center PPDS — Tel Aviv

Идентификаторы

NCT: NCT05927571 · GO43979 · 2023-504657-13-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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