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

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-506260-14-00
Acronym
64407564MMY2006
Enrollment
60
Registered
2024-07-22
Start date
2025-05-13
Completion date
Unknown
Last updated
2025-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

multiple myeloma

Brief summary

As determined by the total WETT testing score: - Rate of occurrence of taste dysfunction dysgeusia - Rate of occurrence of severe dysgeusia - Time to the first onset of severe dysgeusia - Rate of resolution/improvement of dysgeusia at the end of months 3 and 6

Interventions

DRUGClonazepam Orally Disintegrating Tablets
DRUGUSP
DRUGPregabalin-ratiopharm® 25 mg Hartkapseln
DRUGPregabalin-ratiopharm® 50 mg Hartkapseln
DRUGDEXAMETHASONE ELIXIR

Sponsors

Janssen - Cilag International
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
As determined by the total WETT testing score: - Rate of occurrence of taste dysfunction dysgeusia - Rate of occurrence of severe dysgeusia - Time to the first onset of severe dysgeusia - Rate of resolution/improvement of dysgeusia at the end of months 3 and 6

Countries

Netherlands, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026