A Study to Assess Adverse Events of Intravenously (IV) Infused Etentamig (ABBV-383) in Adult Participants With Relapsed or Refractory Multiple Myeloma

Официальное название

A Multicenter, Phase 1b, Open-label Study to Evaluate Dose Optimization Measures and Safety of Etentamig (ABBV-383) in Subjects With Relapsed or Refractory Multiple Myeloma

Обзор

Multiple Myeloma (MM) is a cancer of the blood's plasma cells ( blood cell). 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 adverse events and change in disease symptoms of etentamig (ABBV-383) in adult participants with relapsed/refractory (R/R) MM. Etentamig (ABBV-383) is an investigational drug being developed for the treatment of R/R Multiple Myeloma (MM). This study is broken into 4 Arms; Arm A (Parts 1 and 2), Arm B and Arms C \& D. Arm A includes 2 parts: step-up dose optimization (Part 1) and dose expansion (Part 2). In Part 1, different level of step-up doses are tested followed by the target dose of etentamig (ABBV-383). In Part 2, the step-up dose identified in Part 1 (Dose A) will be used followed by the target dose A of etentamig (ABBV-383). In Arm B a flat dose of etentamig (ABBV-383) will be tested. In Arms C \& D, the step-up dose identified in Arm A will be used followed by the target dose of etentamig (ABBV-383) to investigate outpatient administration of etentamig (ABBV-383). Around 210 adult participants with relapsed/refractory multiple myeloma will be enrolled at approximately 50 sites across the world. Participants will receive etentamig (ABBV-383) as an infusion into the vein in 28 day cycles for approximately 3 years. 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 (ABBV-383)
  Intravenous Infusion

Первичные конечные точки

• Arm A (Part 1 and Part 2) Arm C, and Arm D: Number of Grade >= 2 Cytokine Release Syndrome (CRS) Events [Срок оценки: Up to Day 28]
• Arm B: Number of Adverse Events (AEs) of Special Interest (CRS and Immune Effector Cell-associated Neurotoxicity Syndrome [ICANS]) [Срок оценки: Up to Day 28]

Вторичные конечные точки (1)

• Arm A, Arm C. and Arm D: Number of Cytokine Release Syndrome (CRS) Events [Срок оценки: Up to 3 Years]

Критерии участия

Критерии включения

• Must have measurable disease as outlined in the protocol.
• Eastern Cooperative Oncology Group (ECOG) performance of <= 2. Arm C and Arm D: ECOG performance of <= 1.
• Relapsed/refractory (R/R) multiple myeloma (MM) with documented evidence of progression during or after the participant's last treatment regimen based on the investigator's determination of the International Myeloma Working Group (IMWG) 2016 criteria.
• Must be naïve to treatment with etentamig (ABBV-383).
• Arm A: Must have received at least 3 or more lines of therapy, including a proteasome inhibitor (PI), an immunomodulatory imide drug (IMiD), and an anti-CD38 monoclonal antibody.
• Arm B: Must have received at least 2 or more lines of therapy, including exposure to a PI, an IMiD, an anti-CD38 monoclonal antibody, and a prior B-cell maturation antigen (BCMA)-targeted therapy (must be an anti-drug conjugate \[ADC\] or chimeric antigen receptor T-cell \[CAR-T\] directed against BCMA).
• Arm C: Must have received at least 2 or more lines of therapy, including exposure to a PI, an IMiD, and an anti-CD38 monoclonal antibody. Must be suitable for outpatient administration of etentamig (ABBV-383).
• Arm D: Must have received at least 1 and no more than 3 prior lines of therapy, including exposure to a PI, an IMiD, or an anti-CD38 monoclonal antibody. Must be suitable for outpatient administration of etentamig (ABBV-383).

Критерии исключения

• Arm A: Received BCMA-targeted therapy.
• Arm C and Arm D: Rapidly progressing disease per investigator.

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 · 27 центров

• Mayo Clinic Arizona /ID# 251405 — Phoenix
• Highlands Oncology Group - Springdale /ID# 267742 — Springdale
• Rocky Mountain Cancer Centers - Aurora /ID# 268574 — Aurora
• Medical Oncology Hematology Consultants /ID# 268560 — Newark
• Hope And Healing Cancer Services /ID# 268536 — Hinsdale
• Fort Wayne Medical Oncology And Hematology /ID# 268179 — Fort Wayne
• Franciscan St. Francis Health /ID# 280928 — Indianapolis
• Tulane University School of Medicine /ID# 251204 — New Orleans
• … и ещё 19 центров

Франция · 6 центров

• Institut Paoli-Calmettes /ID# 252100 — Marseille
• Hopitaux Universitaires Henri Mondor - Hopital Henri Mondor /ID# 252101 — Créteil
• Centre Hospitalier Universitaire de Nantes, Hotel Dieu -HME /ID# 251196 — Nantes
• HCL - Hopital Lyon Sud /ID# 251223 — Pierre-Bénite
• CHU Poitiers - La miletrie /ID# 251219 — Poitiers
• AP-HP - Hopital Saint-Antoine /ID# 252326 — Paris

Израиль · 4 центра

• Rabin Medical Center. /ID# 251330 — Petah Tikva
• Hadassah Medical Center-Hebrew University /ID# 252079 — Jerusalem
• The Chaim Sheba Medical Center /ID# 251329 — Ramat Gan
• Tel Aviv Sourasky Medical Center /ID# 251573 — Tel Aviv

Испания · 3 центра

• Hospital Universitario Marques de Valdecilla /ID# 251528 — Santander
• Hospital Universitario Puerta de Hierro - Majadahonda /ID# 251545 — Majadahonda
• Hospital Universitario de Salamanca /ID# 251529 — Salamanca

Канада · 2 центра

• Juravinski Cancer Centre /ID# 252053 — Hamilton
• Ottawa Hospital Research Institute /ID# 252151 — Ottawa

Дания · 2 центра

• Odense University Hospital /ID# 251261 — Odense
• Vejle Sygehus /ID# 251260 — Vejle

Великобритания · 2 центра

• University College London Hospital /ID# 251357 — London
• The Christie Hospital /ID# 251774 — Manchester

Идентификаторы

NCT: NCT05650632 · M24-108 · 2023-504674-38-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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