Study of BiRd Regimen Combined With BCMA CAR T-cell Therapy in Newly Diagnosed Multiple Myeloma (MM) Patients
A Phase 3, Single Arm, Multi-Center Study to Assess the Efficacy and Safety of Clarithromycin(Biaxin)-Lenalidomide-Low-Dose-Dexamethasone (BiRd) Combined With B-cell Maturation Antigen (BCMA)-Directed Chimeric Antigen Receptor (CAR) T-cell Therapy in Patients With Newly Diagnosed Multiple Myeloma
1 other identifier
interventional
20
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 multiple-myeloma
Started Oct 2017
Typical duration for phase_3 multiple-myeloma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 19, 2017
CompletedFirst Submitted
Initial submission to the registry
February 19, 2020
CompletedFirst Posted
Study publicly available on registry
February 27, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2025
CompletedOctober 25, 2021
February 1, 2021
5.3 years
February 19, 2020
October 22, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall response rate (ORR)
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.
4 weeks after CAR T-cells infusion (up to 14 weeks)
Secondary Outcomes (4)
Overall survival (OS)
4 years
Event-free survival (EFS)
4 years
Cumulative incidence of relapse(CIR)
4 years
Number of adverse events
2 years
Study Arms (1)
BiRd combined with BCMA CAR T-cells infusion
EXPERIMENTALInterventions
* 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.
Eligibility Criteria
You may qualify if:
- Newly diagnosed MM according to the criteria by International Myeloma Working Group (IMWG)
- Age 18-75
- Eastern Cooperative Oncology Group (ECOG) score 0-2
- BCMA positive as detected with flowcytometry or ELISA.
- Patients with left ventricular ejection fraction ≥ 0.5 by echocardiography or grade I/II cardiovascular dysfunction according to the New York Heart Association Classification.
- Patients with aspartate aminotransferase or glutamic-pyruvic transaminase \> 3x upper limit of normal or bilirubin \> 2.0 mg/dL
You may not qualify if:
- Patients are pregnant or lactating.
- Nonsecretory MM.
- History of previous treatment of MM.
- Patients with uncontrolled active infection.
- Patients with active hepatitis B or hepatitis C infection.
- Patients with HIV infection.
- Patients with atrial or venous thrombosis or embolism.
- Patients with myo-infarction or severe arrythmia in the recent 6 months.
- Other comorbidities that investigators considered not suitable for this study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The First Affiliated Hospital of Soochow Universitylead
- Changshu Frist People's Hospitalcollaborator
- The Second People's Hospital of Huai'ancollaborator
- Affiliated Hospital of Jiangnan Universitycollaborator
- Jiangsu Province Hospital of Traditional Chinese Medicinecollaborator
- Jiangyin People's Hospitalcollaborator
- Jingjiang People's Hospitalcollaborator
- The Third People's Hospital of Kunshancollaborator
- Lianyungang Hospital Affiliated Bengbu Medical Collegecollaborator
- Suzhou Municipal Hospitalcollaborator
- Zhangjiagang First People's Hospitalcollaborator
- Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltdcollaborator
- The First Affiliated Hospital with Nanjing Medical Universitycollaborator
- Nanjing Medical Universitycollaborator
Study Sites (1)
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xiaowen Tang, Ph.D
The First Affiliated Hospital of Soochow University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 19, 2020
First Posted
February 27, 2020
Study Start
October 19, 2017
Primary Completion
January 31, 2023
Study Completion
January 31, 2025
Last Updated
October 25, 2021
Record last verified: 2021-02