Last updated on September 2020

A Study Comparing JNJ-68284528 a CAR-T Therapy Directed Against B-cell Maturation Antigen (BCMA) Versus Pomalidomide Bortezomib and Dexamethasone (PVd) or Daratumumab Pomalidomide and Dexamethasone (DPd) in Participants With Relapsed and Lenalidomide-Refractory Multiple Myeloma

Brief description of study

The purpose of this study is to compare the efficacy of JNJ-68284528 with standard therapy, either Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd).

Detailed Study Description

Multiple myeloma is a malignant plasma cell disorder diagnosed annually in approximately 86,000 participants worldwide. JNJ-68284528 is an autologous chimeric antigen receptor T-cell (CAR-T) therapy that targets B-cell maturation antigen (BCMA), a molecule expressed on the surface of mature B lymphocytes and malignant plasma cells. The primary hypothesis for this study is that JNJ-68284528 will significantly improve progression free survival (PFS) compared with standard therapy (PVd or DPd), in participants who have previously received 1 to 3 prior line(s) of therapy, that included a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD) and who are refractory to lenalidomide. This study will be conducted in 3 phases: Screening (up to 28 days before randomization), Treatment, and Follow-Up. Assessment like patient-reported outcome(s) (PROs) assessments, electrocardiogram (ECG), vital signs, pharmacokinetic will be performed during the study. Safety evaluations will include review of adverse events, laboratory test results, vital sign measurements, physical examination findings, and assessments of cardiac function, Immune Effector Cell-associated Encephalopathy (only for Arm B) and Eastern Cooperative Oncology Group performance status. Safety data will be periodically reviewed by an Independent Data Monitoring Committee (IDMC). The duration of the study is approximately 6 years.

Clinical Study Identifier: NCT04181827

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Yale New Haven Hospital

New Haven, CT United States
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University of Kansas

Westwood, KS United States
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University Of Minnesota

Minneapolis, MN United States
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Mayo Clinic - Rochester

Rochester, MN United States
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The Ohio State University

Columbus, OH United States
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Huntsman Cancer Institute

Salt Lake City, UT United States
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Medical College Of Wisconsin

Milwaukee, WI United States
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Alfred Health

Melbourne, Australia
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UZ Gent

Gent, Belgium
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UZ Leuven

Leuven, Belgium
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Copenhagen, Denmark
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Hopital Saint-Louis

Paris cedex 10, France
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Centre hospitalier Lyon-Sud

Pierre Benite cedex, France
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Samsung Medical Center

Seoul, Korea, Republic of
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VU Medisch Centrum

Amsterdam, Netherlands
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Erasmus MC

Rotterdam, Netherlands
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UMC Utrecht

Utrecht, Netherlands
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Queen Elizabeth Hospital

Birmingham, United Kingdom
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Bristol Royal Infirmary

Bristol, United Kingdom
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Christie Hospital

Manchester, United Kingdom
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Freeman Hospital

Newcastle Upon Tyne, United Kingdom
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Recruitment Status: Open

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