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

NCT04634552

RecruitingPhase 2

Sponsor: Janssen Research & Development, LLC

Conditions: Hematological Malignancies

Interventions: Talquetamab

Countries: United States, Belgium, China, France, Germany, Israel, Japan, Netherlands

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).

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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)
Locations (78)
  • Birmingham, Alabama, United States
  • Little Rock, Arkansas, United States
  • Duarte, California, United States
  • Hollywood, Florida, United States
  • Atlanta, Georgia, United States
  • Chicago, Illinois, United States
  • Louisville, Kentucky, United States
  • Ann Arbor, Michigan, United States
  • St Louis, Missouri, United States
  • New York, New York, United States
  • New York, New York, United States
  • Rochester, New York, United States
  • Portland, Oregon, United States
  • Nashville, Tennessee, United States
  • Edegem, Belgium
  • Leuven, Belgium
  • Liège, Belgium
  • Woluwe-Saint-Lambert, Belgium
  • Beijing, China
  • Guangzhou, China
  • Hangzhou, China
  • Hangzhou, China
  • Suzhou, China
  • Tianjin, China
  • Xi'an, China
  • Xi'an, China
  • Créteil, France
  • Lyon, France
  • Montpellier, France
  • Nantes, France
  • + 48 more on CT.gov