Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
study ends around
Principal Investigator
by Alfred Chung
Headshot of Alfred Chung
Alfred Chung

Description

Summary

The purpose of this study is to identify preventive treatments that can minimize the occurrence, severity, and duration of talquetamab-related taste changes (dysgeusia), during the prophylaxis (preventive) treatment phase, and to better characterize the signs or symptoms of talquetamab-related taste changes.

Official Title

A Phase 2, Open-label, Randomized Study to Evaluate Prophylactic Interventions on Talquetamab-related Oral Toxicity

Keywords

Relapse Multiple Myeloma, Refractory Multiple Myeloma, Multiple Myeloma, Plasma Cell Neoplasms, Talquetamab, Prophylaxis A, Prophylaxis B, Prophylaxis C, Prophylaxis A and Talquetamab, Prophylaxis B and Talquetamab, Prophylaxis C and Talquetamab

Eligibility

You can join if…

Open to people ages 18 years and up

  • Multiple myeloma (MM) according to IMWG diagnostic criteria
  • Were triple-class exposed (received prior treatment with a PI, an IMiD, and anti CD38 mAb)
  • Documented evidence of progressive disease based on investigator's determination of response by IMWG criteria on or after their last regimen
  • Have an Eastern Cooperative Oncology Group-performance status (ECOG-PS) of 0 or 1 at screening. Participants with ECOG-PS 2 or 3 are eligible for the study if the ECOG-PS score is related to stable physical limitations (e.g., wheelchair-bound due to prior spinal cord injury) and not related to multiple myeloma or associated therapy
  • Be willing and able to adhere to the lifestyle restrictions specified in the protocol

You CAN'T join if...

  • Contraindications or life-threatening known allergies, hypersensitivity, or intolerance to any study drug or its excipients
  • Stroke, transient ischemic attack, or seizure within 6 months prior to screening
  • Any of the following within 6 months prior to the first dose of study treatment: severe or unstable angina, myocardial infarction; major thromboembolytic event (e.g., pulmonary embolism, cerebrovascular accident), clinically significant ventricular arrythmia or heart failure New York Heart Association functional classification Class III or IV. Uncomplicated deep vein thrombosis is not considered exclusionary
  • Major surgery or had significant traumatic injury within 2 weeks prior to the start of administration of talquetamab, or will not have fully recovered from surgery, or has major surgery planned during the time the participant is expected to be treated in the study or within 2 weeks after administration of the last dose of study treatment
  • A WETT score suggesting severe dysgeusia at screening. Also unresolved/severe dysgeusia referred by the participant or a finding in the physical examination/oral cavity inspection. Some examples include leukoplakia, prior mouth cancers, extensive dental caries, severe periodontitis, active oral infections, candidiasis, parotic gland removal, or radiotherapy with resultant xerostomia

Locations

  • UCSF accepting new patients
    San Francisco California 94143 United States
  • University of Washington accepting new patients
    Seattle Washington 98109 United States

Lead Scientist at UCSF

  • Alfred Chung
    Dr. Alfred Chung is a hematologist-oncologist who cares for patients with blood cancers, including leukemias, lymphomas and myelomas. He sees patients who are in the hospital for treatment, including those who need a bone marrow transplant and those receiving chemotherapy or cellular therapies to bolster the immune system.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Janssen Research & Development, LLC
ID
NCT06500884
Phase
Phase 2 Multiple Myeloma Research Study
Study Type
Interventional
Participants
Expecting 130 study participants
Last Updated