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

Launched by JANSSEN RESEARCH & DEVELOPMENT, LLC · Nov 16, 2020

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called talquetamab for people with relapsed or refractory multiple myeloma, which is a type of blood cancer. The goal is to see how well this treatment works and how safe it is for patients. The trial is currently recruiting participants, and those who are between the ages of 65 to 74 may be eligible to join.

To qualify for the trial, participants need to have a confirmed diagnosis of multiple myeloma that can be measured by tests. They should also have a good performance level, meaning they can carry out daily activities with minimal assistance. Women who can become pregnant must have a negative pregnancy test before starting the treatment. Participants will be monitored throughout the study to track their health and any side effects. It's important to note that individuals who have recently undergone certain other cancer therapies or have specific health issues may not be able to participate. Overall, this trial aims to explore a potential new option for patients who have not responded to previous treatments.

Gender

ALL

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)