Clinical trial NCT06500884: A Study to Evaluate Preventive Treatments for Talquetamab-related Oral Toxicity
Official title: A Phase 2, Open-label, Randomized Study to Evaluate Prophylactic Interventions on Talquetamab-related Oral Toxicity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Relapse Multiple Myeloma
Refractory Multiple Myeloma
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2024-07-15
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Percentage of Participants With Occurrence of Dysgeusia as Assessed by the Total Waterless Empirical Taste Test (WETT) Testing Score During the Prophylaxis Treatment Phase
timeFrame: Up to 12 months
measure: Percentage of Participants With Occurrence of Severe Dysgeusia During the Prophylaxis Treatment Phase
timeFrame: Up to 12 months
measure: Time to the First Onset of Severe Dysgeusia During the Prophylaxis Treatment Phase
timeFrame: Up to 12 months
measure: Percentage of Participants Who Report Resolution/Improvement of Dysgeusia During the Prophylaxis Treatment Phase
timeFrame: At Month 3
measure: Percentage of Participants Who Report Resolution/Improvement of Dysgeusia During the Prophylaxis Treatment Phase
timeFrame: At Month 6
Secondary outcomes:
measure: Change From Baseline in WETT Testing Score Over Time
timeFrame: Baseline up to 30 months
measure: Percentage of Time with Dysgeusia During the Prophylaxis Treatment Phase
timeFrame: Up to 12 months
measure: Number of Participants with Treatment-emergent Oral Toxicities (Dysgeusia, Oral Mucositis, Dysphagia, and Xerostomia) During the Prophylaxis Treatment Phase
timeFrame: Up to 12 months
measure: Number of Participants with Treatment-emergent Oral Toxicities (Dysgeusia, Oral Mucositis, Dysphagia, and Xerostomia) Over Time
timeFrame: Up to 30 months
measure: Time to the First Onset of Treatment-emergent Oral Toxicities (Dysgeusia, Oral Mucositis, Dysphagia, and Xerostomia)
timeFrame: Up to 30 months
measure: Duration of Treatment-emergent Oral Toxicities (Dysgeusia, Oral Mucositis, Dysphagia, and Xerostomia)
timeFrame: Up to 30 months
measure: 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
timeFrame: From Baseline up to 30 months
measure: 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
timeFrame: From Baseline up to 30 months
measure: Percentage of Participants Reporting Oral Symptoms Using the Patient-reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
timeFrame: Up to 12 months
measure: Percentage of Participants Reporting Oral Symptoms Using the Short Xerostomia Inventory (SXI) Score
timeFrame: Up to 30 months
measure: Percentage of Participants Reporting Oral Symptoms Using the Epstein Taste Survey (ETS)
timeFrame: Up to 30 months
measure: Percentage of Participants Reporting Oral Symptoms Using the Scale of Subjective Total Taste Acuity (STTA)
timeFrame: Up to 12 months
measure: Change from Baseline in Body Weight Over Time
timeFrame: From Baseline up to 30 months
measure: Change from Baseline in Body Mass Index (BMI) Over Time
timeFrame: From Baseline up to 30 months
measure: Percentage of Participants With Dose Reductions, Interruptions, and Discontinuations
timeFrame: Up to 12 months
measure: Change from Baseline in Smell Identification Test Score
timeFrame: Baseline (Day 1 Cycle 1), Day 1 Cycle 2 (each cycle duration=28-days)
measure: Change from Baseline in Smell Detection Threshold Test Score
timeFrame: Baseline (Day 1 Cycle 1), Day 1 Cycle 2 (each cycle duration=28-days)
measure: Percentage of Participants With Overall Response Rate
timeFrame: Up to 30 months
measure: Percentage of Participants With Complete Response (CR) or Better Response
timeFrame: Up to 30 months
measure: Percentage of Participants With Very Good Partial Response (VGPR) or Better Response
timeFrame: Up to 30 months
measure: Duration of Response (DOR)
timeFrame: Up to 30 months
measure: Time to Response (TTR)
timeFrame: Up to 30 months
measure: Progression-free Survival (PFS)
timeFrame: Up to 30 months
measure: Number of Participants with Treatment-emergent Adverse Event (TEAEs)
timeFrame: Up to 30 months
Other outcomes:
Locations:
city: Denver
country: United States
facility: Colorado Blood Cancer Institute
state: Colorado
city: New Haven
country: United States
facility: Yale University School Of Medicine
state: Connecticut
city: New York
country: United States
facility: Icahn School of Medicine at Mt. Sinai
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Richmond
country: United States
facility: Virginia Commonwealth University - Massey Cancer Center
state: Virginia
city: Sao Paulo
country: Brazil
facility: Instituto D Or de Pesquisa e Ensino IDOR
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea Seoul St Mary s Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: San Juan
country: Puerto Rico
facility: Hospital Espanol Auxilio Mutuo Auxilio Mutuo Cancer Center
city: Badalona
country: Spain
facility: Hosp. Univ. Germans Trias I Pujol
city: El Palmar
country: Spain
facility: Hosp. Univ. Virgen de La Arrixaca
city: Madrid
country: Spain
facility: Hosp. Univ. Ramon Y Cajal
city: Madrid
country: Spain
facility: Hosp. Univ. 12 de Octubre
city: Salamanca
country: Spain
facility: Hosp Clinico Univ de Salamanca
city: Liverpool
country: United Kingdom
facility: The Clatterbridge Cancer Centre
city: London
country: United Kingdom
facility: University College London Hospitals
city: London
country: United Kingdom
facility: Hammersmith Hospital
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: