An Investigator-Initiated, Phase II, Multicenter, Open-Label, Single-Arm, Prospective Clinical Trial to Evaluate the Efficacy and Safety of Alternating Bortezomib-Based Regimens in Combination With DaratUMumab Followed by Maintenance With Daratumumab in the Frontline Setting of Primary Plasma CEll L

The primary objective of this study is to evaluate the efficacy of the alternating D-PAD/D-CVD induction regimen followed by D-CVD consolidation regimen and maintenance with daratumumab monotherapy, in terms of PFS, in the first-line setting of pPCL.

Trial Details

NCT ID
NCT06636552
Phase
PHASE2
Sponsor
Hellenic Society of Hematology
Status
RECRUITING
Cancer Type
Multiple Myeloma
Interventions
  • Daratumumab (Subcutaneously)
Locations (sample)
  • Athens, Attica, Greece|37.98376,23.72784
  • Athens, Attica, Greece|37.98376,23.72784
  • Athens, Attica, Greece|37.98376,23.72784
  • Alexandroupoli, Evros, Greece|40.84995,25.87644
  • Piraeus, Greece|37.94203,23.64619

Key Eligibility Criteria

  • Age between 18 and 80 years (inclusive) at the time of signing the informed consent.
  • Patients newly diagnosed with documented pPCL as defined by the current IMWG criteria for PCL and MM:
  • Documented presence of ≥5% PBPCs and/or absolute number ≥0.5 × 103/μL, assessed either morphologically in the peripheral blood (PB) smear or by flo…
  • Clonal BMPCs ≥10% or biopsy-proven bony or extramedullary plasmacytoma

For full eligibility, visit ClinicalTrials.gov.

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