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MonumenTAL-1* Multiple myeloma
A Phase 2, nonrandomized study of talquetamab (GPRC5D × CD3 bispecific Ab) in participants with relapsed or refractory MM who have received ≥3 prior lines of therapy
Phase
Compound
Talquetamab (GPRC5D × CD3 bispecific Ab)
NCT identifier
NCT04634552
Enrollment

N=~510

For more information, including
contact details, please visit
the J&J Clinical Trial Finder
Study overview & design

Key eligibility criteria:

  • MM diagnosis according to IMWG criteria
  • ECOG PS 0–2
  • Cohorts A and C: received ≥3 prior lines of therapy and have not been exposed to a CAR T-cell or T-cell redirection therapy
  • Cohort B: received ≥3 prior lines of therapy and have been exposed to T-cell redirection therapy within 3 months
  • Cohort D: received ≥3 prior lines of therapy and have not been exposed to T-cell redirection therapies
  • Cohort E: received at least 1 PI, 1 IMiD, and 1 anti-CD38 monoclonal antibody and have not been exposed to T-cell redirection therapies
  • No history of stroke or seizure within 6 months prior to treatment
Study design
Study design

Primary outcome:

  • ORR

Secondary outcomes:

  • DOR
  • ≥VGPR
  • ≥CR
  • sCR
  • TTR
  • PFS
  • OS
  • MRD negativity
  • AEs
  • SAEs
  • Change in HRQoL

*Only recruiting for Cohort E. Not a complete list of inclusion and exclusion criteria. Not a complete list of secondary outcomes.
Ab, antibody; AE, adverse event; CAR, chimeric antigen receptor; 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; HRQoL, health-related quality of life; IMiD, immunomodulatory drug; IMWG, International Myeloma Working Group; MM, multiple myeloma; MRD, minimal residual disease; ORR, overall response rate; OS, overall survival; PFS, progression-free survival; PI, proteosome inhibitor; SAE, serious adverse event; sCR, stringent complete response; SC, subcutaneous; TTR, time to response; VGPR, very good partial response.

Recruiting site locations
World Map
Belgium, China, France, Germany, Israel, Japan, Netherlands, Poland, South Korea, Spain, United States
Study design
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Mechanism of disease in multiple myeloma
Mechanism of disease in multiple myeloma
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