Print

Purpose

The purpose of this study is to evaluate the efficacy and safety of talquetamab in participants with relapsed or refractory multiple myeloma at the recommended Phase 2 dose(s) (RP2Ds) (Part 3).

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Documented initial diagnosis of multiple myeloma according to international myeloma working group (IMWG) diagnostic criteria - Part 3: Measurable disease cohort A, cohort B, cohort C and cohort D: multiple myeloma must be measurable by central laboratory assessment; Cohort E: Multiple myeloma must be measurable by local laboratory assessment - Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2 - Women of childbearing potential must have a negative pregnancy test at screening and prior to the first dose of study drug using a highly sensitive pregnancy test either serum (beta human chorionic gonadotropin [hCG]) or urine - Willing and able to adhere to the prohibitions and restrictions specified in this protocol

Exclusion Criteria

  • Part 3 only: Cohort A and Cohort C only: exposed to a CAR-T or T cell redirection therapy at any time. Cohort B, Cohort D and Cohort E: T cell redirection therapy within 3 months - Toxicities from previous anticancer therapies should have resolved to baseline levels or to Grade 1 or less except for alopecia or peripheral neuropathy - Received a cumulative dose of corticosteroids equivalent to >= 140 milligram (mg) of prednisone within the 14-day period before the first dose of study drug (does not include pretreatment medication) - Stroke or seizure within 6 months prior to signing the informed consent form (ICF)

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Part 3: Cohort A (Talquetamab) 		Cohort A will enroll participants with multiple myeloma who have previously received greater than or equal to (>=) 3 prior lines of therapy and have not been exposed to T cell redirection therapies. Participants will receive talquetamab subcutaneously (SC) at a recommended Phase 2 dose (RP2D) selected after review of safety, efficacy, PK, and pharmacodynamic data from Part 1 and Part 2 of this study. All participants (ongoing and those who are in follow-up) will transition to open-label extension (OLE) phase and will continue to receive the study treatment. Upon approval of amendment 19 and notification from the sponsor, participants will transition to the long-term extension (LTE) and will continue to receive study treatment.
  • Drug: Talquetamab
    Talquetamab will be administered SC until disease progression.
    Other names:
    • JNJ-64407564
Experimental
Part 3: Cohort B (Talquetamab) 		Cohort B will enroll participants with multiple myeloma who have previously received >= 3 prior lines of therapy and have been exposed to T cell redirection therapies. Participants will receive talquetamab subcutaneously (SC) at a recommended Phase 2 dose (RP2D) selected after review of safety, efficacy, PK, and pharmacodynamic data from Part 1 and Part 2 of this study. All participants (ongoing and those who are in follow-up) will transition to OLE phase and will continue to receive the study treatment. Upon approval of amendment 19 and notification from the sponsor, participants will transition to the LTE and will continue to receive study treatment.
  • Drug: Talquetamab
    Talquetamab will be administered SC until disease progression.
    Other names:
    • JNJ-64407564
Experimental
Part 3: Cohort C (Talquetamab) 		Cohort C will enroll participants with multiple myeloma who have previously received >= 3 prior lines of therapy and have not been exposed to T cell redirection therapies. Participants will receive talquetamab SC biweekly at a RP2D selected after review of safety, efficacy, PK, and pharmacodynamic data from Part 1 and Part 2 of this study. All participants (ongoing and those who are in follow-up) will transition to OLE phase and will continue to receive the study treatment. Upon approval of amendment 19 and notification from the sponsor, participants will transition to the LTE and will continue to receive study treatment.
  • Drug: Talquetamab
    Talquetamab will be administered SC until disease progression.
    Other names:
    • JNJ-64407564
Experimental
Part 3: Cohort D (Talquetamab) 		Cohort D will enroll participants with multiple myeloma who have previously received >= 3 prior lines of therapy. Participants will receive talquetamab SC biweekly at a RP2D selected after review of safety, efficacy, PK, and pharmacodynamic data from Part 1 and Part 2 of this study. Participants in this cohort will receive tocilizumab prophylaxis for cytokine release syndrome (CRS) including all outpatient dosing. Participants will transition to OLE upon communication by the sponsor. Upon approval of amendment 19 and notification from the sponsor, participants will transition to the LTE and will continue to receive study treatment.
  • Drug: Talquetamab
    Talquetamab will be administered SC until disease progression.
    Other names:
    • JNJ-64407564
Experimental
Part 3: Cohort E (Talquetamab) 		Cohort E will enroll participants with multiple myeloma who have previously received at least 1 proteasome inhibitor (PI), 1 immunomodulatory imide drug (IMiD), and 1 anti-cluster of differentiation 38 (CD38) monoclonal antibody. Participants will receive talquetamab SC biweekly at a RP2D selected after review of safety, efficacy, PK, and pharmacodynamic data from Part 1 and Part 2 of this study. Participants will receive tocilizumab prophylaxis for CRS with consolidated priming dose schedules as well as possible transition to outpatient priming dosing transition to OLE upon communication by the sponsor. Upon approval of amendment 19 and notification from the sponsor, participants will transition to the LTE and will continue to receive study treatment.
  • Drug: Talquetamab
    Talquetamab will be administered SC until disease progression.
    Other names:
    • JNJ-64407564

Recruiting Locations

University of Alabama Birmingham
Birmingham 4049979, Alabama 4829764 35294

University of Arkansas for Medical Sciences
Little Rock 4119403, Arkansas 4099753 72205

Memorial Healthcare System
Hollywood 4158928, Florida 4155751 33021

Emory University Winship Cancer Institute
Atlanta 4180439, Georgia 4197000 30322

University of Chicago
Chicago 4887398, Illinois 4896861 60637

Norton Cancer Institute
Louisville 4299276, Kentucky 6254925 40207

University of Michigan Health System
Ann Arbor 4984247, Michigan 5001836 48109

Washington University School Of Medicine
St Louis 4407066, Missouri 4398678 63110

NYU Langone Health
New York 5128581, New York 5128638 10016

Mount Sinai Medical Center
New York 5128581, New York 5128638 10023

University of Rochester Medical Center
Rochester 5134086, New York 5128638 14642

Tennessee Oncology
Nashville 4644585, Tennessee 4662168 37203

More Details

NCT ID
NCT04634552
Status
Recruiting
Sponsor
Janssen Research & Development, LLC

Study Contact

Study Contact
844-434-4210
Participate-In-This-Study1@its.jnj.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.