Study of Teclistamab in Combination in Elderly Patients With Multiple Myeloma

The primary hypothesis of this study is that teclistamab SC in combination with daratumumab SC or lenalidomide will be safe and induce a high rate of VGPR or better in newly diagnosed multiple myeloma patients This is an open-label, multicenter, non-comparative, 2-cohort, 2-stage with interruption of enrollment for an efficacy and safety interim analysis, interventional Phase 2 study evaluating the efficacy and safety of a combination with Tec-Dara (Cohort A) or Tec-Len (Cohort B) in patients with newly diagnosed multiple myeloma who are not eligible for SCT.

Trial Details

NCT ID
NCT05572229
Phase
PHASE2
Sponsor
University Hospital, Lille
Status
RECRUITING
Cancer Type
Newly Diagnosed Multiple Myeloma
Interventions
  • Teclistamab
  • Daratumumab
  • Lenalidomide
Locations (sample)
  • Amiens, France|49.9,2.3
  • Angers, France|47.47156,-0.55202
  • Avignon, France|43.94834,4.80892
  • Bayonne, France|43.49316,-1.473
  • Besançon, France|47.24878,6.01815

Key Eligibility Criteria

  • Patient must be at least ≥65 years of age at the time of informed consent with documented multiple myeloma as defined by the criteria below:
  • Multiple myeloma diagnosis according to IMWG diagnostic criteria
  • Measurable disease at Screening as defined by any of the following:
  • Serum monoclonal paraprotein (M-protein) level ³ 0.5 g/dL; or Urine M protein level ³ 200 mg/24 hours; or Serum Ig FLC ³ 10 mg/dL and abnormal seru…

For full eligibility, visit ClinicalTrials.gov.

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