OncoMatch/Clinical Trials/NCT05979363
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
Is NCT05979363 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies multiple treatments including anti-BCMA CAR-T and VRD-based regimen for plasma cell leukemia.
Treatment: anti-BCMA CAR-T · VRD-based regimen — 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
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Multiple Myeloma
Biomarker criteria
Required: BCMA (TNFRSF17) overexpression (BCMA-positive by flow cytometry or pathological examination)
Bone marrow sample is confirmed as BCMA-positive by flow cytometry or pathological examination.
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
Prior therapy
Cannot have received: BCMA-targeted therapy
Prior exposure to any BCMA-targeted therapy
Cannot have received: CAR-T cell therapy
Prior exposure to any ... CAR-T therapy
Lab requirements
Blood counts
WBC ≥ 1.5 x 10^9/L, ANC ≥ 1.0 x 10^9/L, Hb ≥ 70 g/L, PLT ≥ 75 x 10^9/L (if BMPC < 50%) or PLT ≥ 50 x 10^9/L (if BMPC ≥ 50%)
Kidney function
Creatinine clearance ≥ 30mL/min (Cockroft-Gault formula)
Liver function
TBIL <2 x ULN (<3 x ULN in patients with Gilbert's syndrome); AST and ALT <3 x ULN
Screening laboratory values must meet the following criteria: a.TBIL<2 x upper limit of normal (ULN) (<3 x ULN in patients with Gilbert's syndrome); b.AST and ALT <3 x ULN.; c. Creatinine clearance ≥ 30mL/min (calculated using Cockroft-Gault formula). Routine blood tests ... : WBC ≥ 1.5 x 109/L, ANC ≥ 1.0 x 109/L, Hb ≥ 70 g/L PLT ≥ 75 x 109/L (if BMPC < 50%) or PLT ≥ 50 x 109/L (if BMPC ≥ 50%).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT05979363 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior BCMA-targeted therapy, CAR-T cell therapy disqualifies patients from enrollment.
Does this trial require TNFRSF17?
Yes, TNFRSF17 overexpression is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages