Back to search
A Study to Evaluate Preventive Treatments for Talquetamab-related Oral Toxicity
Refractory Multiple Myeloma
Relapse Multiple Myeloma
Clinicaltrials.gov:
EU CTIS:
#2023-506260-14-00
Other:
#64407564MMY2006
Trials at a glance
Status
Enrolling
Condition
Refractory Multiple Myeloma
Relapse Multiple Myeloma
Trial type
Interventional
Trial phase
Phase 2
Investigational
product
product
Prophylaxis A
Prophylaxis B
Prophylaxis C
Talquetamab
Age
18+ years old
Biological sex
All
Placebo?
No
Trial start date
August 26, 2024
Trial end date
April 30, 2029
CT.gov ID
#NCT06500884
Share the trial ID with your doctor to see if trial participation is right for you. Participation depends on an independent medical assessment.
A Study to Evaluate Preventive Treatments for Talquetamab-related Oral Toxicity
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.
Primary outcome measures
- Percentage of Participants With Occurrence of Dysgeusia as Assessed by the Total Waterless Empirical Taste Test (WETT) Testing Score During the Prophylaxis Treatment Phase
- Percentage of Participants With Occurrence of Severe Dysgeusia During the Prophylaxis Treatment Phase
- Time to the First Onset of Severe Dysgeusia During the Prophylaxis Treatment Phase
- Percentage of Participants Who Report Resolution/Improvement of Dysgeusia During the Prophylaxis Treatment Phase
- Percentage of Participants Who Report Resolution/Improvement of Dysgeusia During the Prophylaxis Treatment Phase
Secondary outcome measures
- Change From Baseline in WETT Testing Score Over Time
- Percentage of Time with Dysgeusia During the Prophylaxis Treatment Phase
- Number of Participants with Treatment-emergent Oral Toxicities (Dysgeusia, Oral Mucositis, Dysphagia, and Xerostomia) During the Prophylaxis Treatment Phase
- Number of Participants with Treatment-emergent Oral Toxicities (Dysgeusia, Oral Mucositis, Dysphagia, and Xerostomia) Over Time
- Time to the First Onset of Treatment-emergent Oral Toxicities (Dysgeusia, Oral Mucositis, Dysphagia, and Xerostomia)
- Duration of Treatment-emergent Oral Toxicities (Dysgeusia, Oral Mucositis, Dysphagia, and Xerostomia)
- Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 items (EORTC-QLQ-C30) Domains Scores Over Time
- Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Oral Health (EORTC-QLQ-OH15) Domains Scores Over Time
- Percentage of Participants Reporting Oral Symptoms Using the Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
- Percentage of Participants Reporting Oral Symptoms Using the Short Xerostomia Inventory (SXI) Score
- Percentage of Participants Reporting Oral Symptoms Using the Epstein Taste Survey (ETS)
- Percentage of Participants Reporting Oral Symptoms Using the Scale of Subjective Total Taste Acuity (STTA)
- Change from Baseline in Body Weight Over Time
- Change from Baseline in Body Mass Index (BMI) Over Time
- Percentage of Participants With Dose Reductions, Interruptions, and Discontinuations
- Change from Baseline in Smell Identification Test Score
- Change from Baseline in Smell Detection Threshold Test Score
- Percentage of Participants With Overall Response Rate
- Percentage of Participants With Complete Response (CR) or Better Response
- Percentage of Participants With Very Good Partial Response (VGPR) or Better Response
- Duration of Response (DOR)
- Time to Response (TTR)
- Progression-free Survival (PFS)
- Number of Participants with Treatment-emergent Adverse Event (TEAEs)
Access detailed information on the trial:
Clinical trials information
© Johnson & Johnson and its affiliates 2026
