Study of BiRd Regimen Combined With BCMA CAR T-cell Therapy in Newly Diagnosed Multiple Myeloma (MM) Patients
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of BiRd regimen combined with BCMA CAR T cell therapy in newly diagnosed multiple myeloma patients
Condition or Disease | Intervention/Treatment | Phase |
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Phase 3 |
Detailed Description
This is a phase 3, single arm, multi-center study. The patients will receive BiRd regimen (clarithromycin,lenalidomide, dexamethasone) combined with infusion of autologous BCMA-directed CAR T-cells in newly diagnosed MM patients. The study participation will be 4 years including treatment and follow-up periods.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: BiRd combined with BCMA CAR T-cells infusion
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Drug: clarithromycin, lenalidomide, dexamethasone and autologous BCMA-directed CAR T-cells
clarithromycin: 500mg, PO, twice daily, on days 1~21 for a 28-day cycle.
lenalidomide: 25mg, PO, on days 1~21 for a 28-day cycle. dexamethasone: 40mg, PO on days 1,8,15 and 22 for a 28-day cycle. BCMA CAR T cell: (2-3)×10E7/kg, intravenously infusion.
Doses should be adjusted according to renal function.
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Outcome Measures
Primary Outcome Measures
- Overall response rate (ORR) [4 weeks after CAR T-cells infusion (up to 14 weeks)]
ORR includes stringent complete response (sCR), complete remission (CR), very good partial remission (VGPR) and partial remission (PR). Stringent complete response (sCR): complete response as defined below plus normal free light chain (FLC) and absence of clonal cells in bone marrow biopsy by immunohistochemistry (κ/λ ratio ≤4:1 or ≥1:2 for κ and λ patients, respectively, after counting ≥100 plasma cells). Complete Response (CR):negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and <5% plasma cells in bone marrow aspirates. Very good partial response (VGPR):serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein plus urine M-protein level <100 mg per 24 h. Partial response (PR): ≥50% reduction of serum M-protein plus reduction in 24 h urine M-protein by ≥90% or to <200 mg per 24 h.
Secondary Outcome Measures
- Overall survival (OS) [4 years]
time from enrollment to the date of death from any cause
- Event-free survival (EFS) [4 years]
time from enrollment to the date of primary refractory disease, or relapse from sCR, or CR, or death from any cause
- Cumulative incidence of relapse(CIR) [4 years]
time from the date of achievement of a remission until the date of relapse
- Number of adverse events [2 years]
adverse events are evaluated with CTCAE V5.0
Eligibility Criteria
Criteria
Inclusion Criteria:
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Newly diagnosed MM according to the criteria by International Myeloma Working Group (IMWG)
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Age 18-75
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Eastern Cooperative Oncology Group (ECOG) score 0-2
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BCMA positive as detected with flowcytometry or ELISA.
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Patients with left ventricular ejection fraction ≥ 0.5 by echocardiography or grade I/II cardiovascular dysfunction according to the New York Heart Association Classification.
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Patients with aspartate aminotransferase or glutamic-pyruvic transaminase > 3x upper limit of normal or bilirubin > 2.0 mg/dL
Exclusion Criteria:
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Patients are pregnant or lactating.
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Nonsecretory MM.
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History of previous treatment of MM.
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Patients with uncontrolled active infection.
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Patients with active hepatitis B or hepatitis C infection.
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Patients with HIV infection.
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Patients with atrial or venous thrombosis or embolism.
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Patients with myo-infarction or severe arrythmia in the recent 6 months.
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Other comorbidities that investigators considered not suitable for this study.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | The First Affiliated Hospital of Soochow University | Suzhou | Jiangsu | China | 215006 |
Sponsors and Collaborators
- The First Affiliated Hospital of Soochow University
- Changshu Frist People's Hospital
- The Second People's Hospital of Huai'an
- Affiliated Hospital of Jiangnan University
- Jiangsu Province Hospital of Traditional Chinese Medicine
- Jiangyin People's Hospital
- Jingjiang People's Hospital
- The Third People's Hospital of Kunshan
- Lianyungang Hospital Affiliated Bengbu Medical College
- Suzhou Municipal Hospital
- Zhangjiagang First People's Hospital
- Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd
- The First Affiliated Hospital with Nanjing Medical University
- The first Affiliated Hospital of Nanjing University Medical School
Investigators
- Principal Investigator: Xiaowen Tang, Ph.D, The First Affiliated Hospital of Soochow University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BiRd-01