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Talisman Multiple myeloma
A Phase 2, randomized, open-label study to evaluate preventive treatments for talquetamab (GPRC5D × CD3 bispecific Ab)-related taste changes and to better characterize the signs or symptoms of ramantamig (BCMA × GPRC5D × CD3 trispecific Ab)-related taste changes in participants with MM
Phase
Compound
Talquetamab (GPRC5D × CD3 bispecific Ab) + prophylaxis A/B/C/D or ramantamig (BMA × GPRC5D × CD3 trispecific Ab)
NCT identifier
NCT06500884
Enrollment

N=~210

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Study overview & design

Key eligibility criteria*:

  • Diagnosed with MM according to IMWG criteria
  • Triple-class exposed (prior treatment with a PI, IMiD, and anti-CD38 mAb)
  • PD based on investigator’s determination of response by IMWG criteria on or after their last regimen
  • ECOG PS 0–1
  • No history of stroke, transient ischemic attack, or seizure within 6 months prior to screening
  • No history of (within 6 months prior to the first dose of study treatment) severe or unstable angina, myocardial infarction, major thromboembolytic event, clinically significant ventricular arrythmia, or heart failure New York Heart Association functional classification Class III or IV
Study design
Study design

Primary outcome:

  • Safety

Secondary outcomes:

  • Change from baseline in WETT Testing Score
  • Percentage of time with dysgeusia during the prophylaxis treatment phase
  • Time to the first onset of treatment-emergent oral toxicities
  • ≥CR
  • DOR
  • HRQoL
  • ORR
  • PFS
  • TTR
  • ≥VGPR

*Not a complete list of inclusion and exclusion criteria. Participants with ECOG PS 2–3 are eligible for the study if ECOG PS is related to stable physical limitations and not related to MM or associated therapy. Not a complete list of outcomes.

Ab, antibody; CD, cluster of differentiation; CR, complete response; DOR, duration of response; ECOG PS, Eastern Cooperative Oncology Group performance status; GPRC5D, G protein–coupled receptor class C group 5 member D; IMiD, immunomodulatory drug; HRQoL, health-related quality of life; IMWG, International Myeloma Working Group; mAb, monoclonal antibody; MM, multiple myeloma; ORR, overall response rate; PD, progressive disease; PFS, progression-free survival; PI, proteasome inhibitor; TTR, time to response; VGPR, very good partial response; WETT, Waterless Empirical Taste Test.

Recruiting site locations
World Map
United States, Brazil, Netherlands, Puerto Rico, South Korea, Spain, United Kingdom
Study design
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