A Study to Evaluate Preventive Treatments for Talquetamab-related Oral Toxicity
NCT Number: NCT06500884
Acronym: Talisman
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Relapse Multiple Myeloma|Refractory Multiple Myeloma
Interventions: DRUG: Talquetamab|DRUG: Prophylaxis A|DRUG: Prophylaxis B|DRUG: Prophylaxis C
Sponsor: Janssen Research & Development, LLC
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-23
Completion Date: 2027-01-15

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

Primary Outcome Measures: Percentage of Participants With Occurrence of Taste Dysfunction (hypogeusia) as Assessed by the Total Waterless Empirical Taste Test (WETT) Testing Score, Taste dysfunction is defined as total WETT score less than or equal to (\<=) 19 for males and \<=21 for females according to the Normative WETT-SA53 percentile table. Taste assessment will be performed using taste strips (WETT). Four concentrations (4=lowest concentration, 1=highest concentration) will be used for each taste quality: sweet, sour, salty, bitter, and umami. Each test kit contains 53 taste strips distributed in 4 packs; and each taste strip is numbered (1 through 53). Participants will use each strip sequentially and record the flavor on a score card provided. The test will result in a maximum (that is, best) total score of 53. The score will be graded by a qualified site staff into a normative percentile score using a provided chart. Scores at or below 19 to 21 (10th percentile) suggest dysfunction, whereas scores at or below 14 (5th percentile) strongly suggest severe hypogeusia or ageusia., Up to 12 months|Percentage of Participants With Occurrence of Severe Hypogeusia/Ageusia, Severe hypogeusia/ageusia is defined as a total WETT score \<=14 according to the Normative WETT-SA53 percentile table. Taste assessment will be performed using taste strips (WETT). Four concentrations (4=lowest concentration, 1=highest concentration) will be used for each taste quality: sweet, sour, salty, bitter, and umami. Each test kit contains 53 taste strips distributed in 4 packs; and each taste strip is numbered (1 through 53). Participants will use each strip sequentially and record the flavor on a score card provided. The test will result in a maximum (that is, best) total score of 53. The score will be graded by a qualified site staff into a normative percentile score using a provided chart. Scores at or below 19 to 21 (10th percentile) suggest dysfunction, whereas scores at or below 14 (5th percentile) strongly suggest severe hypogeusia or ageusia., Up to 12 months|Time to the First Onset of Severe Hypogeusia/Ageusia, Time to the first onset of severe hypogeusia/ageusia is defined as time from the first dose date of talquetamab to the first onset date of severe hypogeusia/ageusia according to the total WETT score. Taste assessment will be performed using taste strips (WETT). Four concentrations (4=lowest concentration, 1=highest concentration) will be used for each taste quality: sweet, sour, salty, bitter, and umami. Each test kit contains 53 taste strips distributed in 4 packs; and each taste strip is numbered (1 through 53). Participants will use each strip sequentially and record the flavor on a score card provided. The test will result in a maximum (that is, best) total score of 53. The score will be graded by a qualified site staff into a normative percentile score using a provided chart. Scores at or below 19 to 21 (10th percentile) suggest dysfunction, whereas scores at or below 14 (5th percentile) strongly suggest severe hypogeusia or ageusia., Up to 12 months|Percentage of Participants Who Report Resolution/Improvement of Hypogeusia/Ageusia, Resolution/improvement is defined as 2 potential scenarios 1) a taste dysfunction downgraded to taste dysfunction-free, i.e., total WETT score \<=19 (males) \& \<=21 (females) at visits prior to Months 3 \& 6 becomes total WETT score \>19 (males) \& \>21 (females) at Months 3 \& 6. 2) Severe hypogeusia/ageusia downgraded to non-severe hypogeusia/ ageusia, i.e., total WETT score \<=14 prior to Months 3 \& 6 becomes total WETT score \>14 at Months 3 \& 6. Taste assessment will be performed using taste strips (WETT). Four concentrations will be used for each taste quality: sweet, sour, salty, bitter, \& umami. Each test kit contains 53 taste strips; numbered (1 through 53). Participants will use each strip sequentially and record flavor on score card provided. Test will result in maximum (i.e., best) total score of 53. Score will be graded by qualified staff into normative percentile score using provided chart. Scores at or below 19 to 21=dysfunction, scores at or below 14=severe hypogeusia/ageusia., At Month 3|Percentage of Participants Who Report Resolution/Improvement of Hypogeusia/Ageusia, Resolution/improvement is defined as 2 potential scenarios 1) a taste dysfunction downgraded to taste dysfunction-free, i.e., total WETT score \<=19 (males) \& \<=21 (females) at visits prior to Months 3 \& 6 becomes total WETT score \>19 (males) \& \>21 (females) at Months 3 \& 6. 2) Severe hypogeusia/ageusia downgraded to non-severe hypogeusia/ ageusia, i.e., total WETT score \<=14 prior to Months 3 \& 6 becomes total WETT score \>14 at Months 3 \& 6. Taste assessment will be performed using taste strips (WETT). Four concentrations will be used for each taste quality: sweet, sour, salty, bitter, \& umami. Each test kit contains 53 taste strips; numbered (1 through 53). Participants will use each strip sequentially and record flavor on score card provided. Test will result in maximum (i.e., best) total score of 53. Score will be graded by qualified staff into normative percentile score using provided chart. Scores at or below 19 to 21=dysfunction, scores at or below 14=severe hypogeusia/ageusia., At Month 6
Secondary Outcome Measures: Change From Baseline in WETT Testing Score Over Time, Taste assessment will be performed using taste strips (WETT). Four concentrations (4=lowest concentration, 1=highest concentration) will be used for each taste quality: sweet, sour, salty, bitter, and umami. Each test kit contains 53 taste strips distributed in 4 packs; and each taste strip is numbered (1 through 53). Participants will use each strip sequentially and record the flavor on a score card provided. The test will result in a maximum (that is, best) total score of 53. The score will be graded by a qualified site staff into a normative percentile score using a provided chart. Scores at or below 19 to 21 (10th percentile) suggest dysfunction, whereas scores at or below 14 (5th percentile) strongly suggest severe hypogeusia or ageusia., Baseline up to 30 months|Percentage of Time with Hypogeusia, Time with hypogeusia is defined as the accumulative days a participant is with taste dysfunction according to the total WETT score divided by the total days of talquetamab exposure. Taste assessment will be performed using taste strips (WETT). Four concentrations (4=lowest concentration, 1=highest concentration) will be used for each taste quality: sweet, sour, salty, bitter, and umami. Each test kit contains 53 taste strips distributed in 4 packs; and each taste strip is numbered (1 through 53). Participants will use each strip sequentially and record the flavor on a score card provided. The test will result in a maximum (that is, best) total score of 53. The score will be graded by a qualified site staff into a normative percentile score using a provided chart. Scores at or below 19 to 21 (10th percentile) suggest dysfunction, whereas scores at or below 14 (5th percentile) strongly suggest severe hypogeusia or ageusia., Up to 12 months|Number of Participants with Treatment-emergent Oral Toxicities (Dysgeusia, Oral Mucositis, Dysphagia, and Xerostomia), Oral toxicity including dysgeusia, oral mucositis, dysphagia, and xerostomia will be graded (including Grade 0 for dysgeusia) based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 5.0. Severity has 5 grades based on CTCAE criteria: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening consequences; and Grade 5: Death., Up to 30 months|Time to the First Onset of Treatment-emergent Oral Toxicities (Dysgeusia, Oral Mucositis, Dysphagia, and Xerostomia), Time to the first onset of treatment-emergent dysgeusia, oral mucositis, dysphagia, or xerostomia, will be summarized using the Kaplan-Meier method., Up to 30 months|Duration of Treatment-emergent Oral Toxicities (Dysgeusia, Oral Mucositis, Dysphagia, and Xerostomia), Duration of treatment-emergent oral toxicities including dysgeusia, oral mucositis, dysphagia, and xerostomia will be reported in this outcome measure., Up to 30 months|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, The EORTC-QLQ-C30 includes 30 items that make up 5 functional scales (physical, role, emotional, cognitive, and social), 1 global health status scale, 3 symptom scales (pain, fatigue, and nausea/vomiting), and 5 single symptom items (dyspnea, insomnia, appetite loss, constipation, and diarrhea) and a single impact item (financial difficulties). The recall period is 7 days, and responses are reported using verbal and numeric rating scales. The item and scale scores are transformed to a 0 to 100 scale. A high scale score represents a higher response level. A high score for a functional scale represents a high/healthy level of functioning and a high score for the global health status represents high health related quality of life (HRQoL), but a high score for a symptom scale/item represents a high level of symptomatology/problems., From Baseline up to 30 months|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, The EORTC module QLQ-OH15 is a 15-item, well-accepted, and validated assessment tool focusing on oral problems and quality of life. The recall period for symptoms is 7 days and response options include 'not at all', "a little', 'quite a bit', and 'very much'. All of the items' measures range in score from 0 to 100. A high score for the symptom items represents a high level of symptomatology or problems., From Baseline up to 30 months|Percentage of Participants Reporting Oral Toxicity Symptoms Using the Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE), PRO-CTCAE is a patient-reported item custom survey used to evaluate symptomatic treatment-emergent adverse events in participants on cancer clinical trials. The PRO-CTCAE custom survey consists of 18 items. Responses are provided on a 5-point Likert scale that ranges from 0 to 4. The recall period for symptoms is 7 days. Higher scores indicating greater severity/impact., Up to 12 months|Percentage of Participants Reporting Oral Toxicity Symptoms Using the Short Xerostomia Inventory (SXI) Score, SXI is a validated questionnaire that explores how the participant experiences dry mouth (xerostomia) with 5 questions extracted from the original XI. Respondents are asked to choose 1 of 5 responses ("1-Never; 2-Hardly ever; 3-Occasionally; 4-Fairly often; and 5-Very often") to specific statements referring to the preceding 4 weeks. Each individual's responses are scored and summed to give a single XI score. Higher scores represent more severe symptoms., Up to 30 months|Percentage of Participants Reporting Oral Toxicity Symptoms Using the Epstein Taste Survey (ETS), The Epstein Taste Survey (ETS) consists of 17 items PRO instrument, specific to taste and smell changes. The ETS was developed for use in participants with head and neck cancer. This instrument will be used to measure treatment-related symptoms associated with talquetamab., Up to 30 months|Percentage of Participants Reporting Oral Toxicity Symptoms Using the Scale of Subjective Total Taste Acuity (STTA), The STTA is a tool to assess the overall acuity of taste based on a 4-point scale, where 0 reflects no change and 4 represents almost complete loss of taste function. Higher score indicating severity., Up to 12 months|Change from Baseline in Body Weight Over Time, Change from baseline in body weight will be reported., From Baseline up to 30 months|Change from Baseline in Body Mass Index (BMI) Over Time, Change from baseline in BMI will be reported., From Baseline up to 30 months|Percentage of Participants With Dose Reductions, Interruptions, and Discontinuations, Percentage of participants with dose reductions, dose interruptions, and dose discontinuations will be reported., Up to 12 months|Change from Baseline in Smell Identification Test Score, Smell identification testing will be performed using 4 booklets each containing 10 labels that will release a distinctive scent when scraped with a pencil. Participants will choose the appropriate scent from the associated options. The minimum possible score is a 0 and the maximum is a 40. A higher score indicates better smell/outcome., Baseline (Day 1 Cycle 1), Day 1 Cycle 4, Day 1 Cycle 8 and Day 1 Cycle 12 (each cycle duration=28-days)|Change from Baseline in Smell Detection Threshold Test Score, Smell threshold detection testing will be performed using vials of rose oil (phenyl ethanol) in vol/vol concentrations ranging from 10\^-2 (strongest) through 10\^-9 (weakest). Participants will be exposed, one at a time, to pairs of vials and asked to distinguish which is stronger., Baseline (Day 1 Cycle 1), Day 1 Cycle 4, Day 1 Cycle 8 and Day 1 Cycle 12 (each cycle duration=28-days)|Percentage of Participants With Overall Response Rate, Overall response rate is defined as the participants with a partial response (PR) or better according to the International Myeloma Working Group (IMWG) criteria., Up to 30 months|Percentage of Participants With Complete Response (CR) or Better Response, CR or better response is defined as the participants who achieve a CR or better response according to the IMWG criteria., Up to 30 months|Percentage of Participants With Very Good Partial Response (VGPR) or Better Response, VGPR or better response is defined as the percentage of participants who achieve a VGPR or better response according to the IMWG criteria., Up to 30 months|Duration of Response (DOR), Duration of response is defined as time from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease, as defined in the IMWG criteria, or death due to disease progression, whichever occurs first., Up to 30 months|Time to Response (TTR), Time to response is defined as the time between date of first dose of study treatment and the first efficacy evaluation at which the participant has met all criteria for PR or better., Up to 30 months|Number of Participants with Treatment-emergent Adverse Event (TEAEs), An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Any AE occurring at or after the initial administration of study treatment through the day of last dose plus 30 days, or if beyond 30 days from last dose but is study treatment-related, is considered to be treatment-emergent., Up to 30 months