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Trial Title:
A Study to Evaluate Preventive Treatments for Talquetamab-related Oral Toxicity
NCT ID:
NCT06500884
Condition:
Relapse Multiple Myeloma
Refractory Multiple Myeloma
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Active, not recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Talquetamab
Description:
Talquetamab will be administered subcutaneously.
Arm group label:
Cohort A: Talquetamab
Arm group label:
Cohort B: Prophylaxis A and Talquetamab
Arm group label:
Cohort C: Prophylaxis B and Talquetamab
Arm group label:
Cohort D: Prophylaxis C and Talquetamab
Other name:
JNJ-64407564
Intervention type:
Drug
Intervention name:
Prophylaxis A
Description:
Prophylaxis A will be administered orally.
Arm group label:
Cohort B: Prophylaxis A and Talquetamab
Intervention type:
Drug
Intervention name:
Prophylaxis B
Description:
Prophylaxis B will be administered orally.
Arm group label:
Cohort C: Prophylaxis B and Talquetamab
Intervention type:
Drug
Intervention name:
Prophylaxis C
Description:
Prophylaxis C will be administered orally.
Arm group label:
Cohort D: Prophylaxis C and Talquetamab
Summary:
The purpose of this study is to identify preventive treatments that can minimize the
occurrence, severity, and duration of talquetamab-related distorted taste (dysgeusia),
during the prophylaxis (preventive) treatment phase, and to better characterize the signs
or symptoms of talquetamab-related distorted taste.
Criteria for 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 enrollment
- 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 study treatment, 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Icahn School of Medicine at Mt. Sinai
Address:
City:
New York
Zip:
10029
Country:
United States
Facility:
Name:
Instituto D Or de Pesquisa e Ensino IDOR
Address:
City:
Sao Paulo
Zip:
04543-000
Country:
Brazil
Facility:
Name:
Seoul National University Hospital
Address:
City:
Seoul
Zip:
03080
Country:
Korea, Republic of
Facility:
Name:
The Catholic University of Korea Seoul St Mary s Hospital
Address:
City:
Seoul
Zip:
06591
Country:
Korea, Republic of
Facility:
Name:
Samsung Medical Center
Address:
City:
Seoul
Zip:
135-230
Country:
Korea, Republic of
Facility:
Name:
Hospital Espanol Auxilio Mutuo Auxilio Mutuo Cancer Center
Address:
City:
San Juan
Zip:
00918
Country:
Puerto Rico
Facility:
Name:
Hosp. Univ. Ramon Y Cajal
Address:
City:
Madrid
Zip:
28034
Country:
Spain
Start date:
August 26, 2024
Completion date:
January 15, 2027
Lead sponsor:
Agency:
Janssen Research & Development, LLC
Agency class:
Industry
Source:
Janssen Research & Development, LLC
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06500884
