Skip to main content
TrialFinder
TrialFinder is for informational purposes only and does not provide medical advice. Always talk to your doctor about whether a trial is right for you.
RECRUITINGPhase 2INTERVENTIONAL

A Study of Talquetamab in Participants With Relapsed or Refractory Multiple Myeloma

A Phase 1/2, First-in-Human, Open-Label, Dose Escalation Study of Talquetamab, a Humanized GPRC5D x CD3 Bispecific Antibody, in Subjects With Relapsed or Refractory Multiple Myeloma

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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).

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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 willing to sign a consent form form (ICF) Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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)

Treatments Being Tested

DRUG

Talquetamab

Talquetamab will be administered SC until disease progression.

Locations (20)

University of Alabama Birmingham
Birmingham, Alabama, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
City of Hope
Duarte, California, United States
Memorial Healthcare System
Hollywood, Florida, United States
Emory University Winship Cancer Institute
Atlanta, Georgia, United States
University of Chicago
Chicago, Illinois, United States
Norton Cancer Institute
Louisville, Kentucky, United States
University of Michigan Health System
Ann Arbor, Michigan, United States
Washington University School Of Medicine
St Louis, Missouri, United States
NYU Langone Health
New York, New York, United States
Mount Sinai Medical Center
New York, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
Providence Portland Medical Center
Portland, Oregon, United States
Tennessee Oncology
Nashville, Tennessee, United States
UZ Antwerpen
Edegem, Belgium
UZ Leuven
Leuven, Belgium
CHU de Liège - Domaine Universitaire du Sart Tilman
Liège, Belgium
UCL - Saint Luc
Woluwe-Saint-Lambert, Belgium
Peking University Third Hospital
Beijing, China
Sun Yat Sen University Cancer Center
Guangzhou, China