A Study of Bortezomib, Lenalidomide and Dexamethasone (VRd)-Based Regimen Followed by BCMA CAR-T Therapy in Transplant-Ineligible Patients With Primary Plasma Cell Leukemia

This is a single-arm, open-label study to evaluate the efficacy and safety of VRD-based regimen combined with BCMA CAR-T in transplant-ineligible patients with primary plasma cell leukemia

Trial Details

NCT ID
NCT05979363
Phase
PHASE2
Sponsor
Institute of Hematology & Blood Diseases Hospital, China
Status
RECRUITING
Cancer Type
Multiple Myeloma
Interventions
  • anti-BCMA CAR-T
  • VRD-based regimen
Locations (sample)
  • Tianjin, China|39.14222,117.17667

Key Eligibility Criteria

  • Age ≥ 18 years and ≤ 75 years.
  • Participants with documented primary plasma cell leukemia according to IMWG diagnostic criteria (circulating plasma cells ≥5%, determined by morpho…
  • Measurable disease, at screening as defined by any of the following: Serum monoclonal paraprotein (M-protein) level ≥1.0 g/dL or urine M-protein le…
  • Not considered for high-dose chemotherapy with Autologous Stem Cell Transplant (ASCT) due to: Ineligible due to advanced age (≥65); or Ineligible e…

For full eligibility, visit ClinicalTrials.gov.

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