Study of BiRd Regimen Combined With BCMA CAR T-cell Therapy in Newly Diagnosed Multiple Myeloma (MM) Patients
NCT ID: NCT04287660
Last Updated: 2021-10-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE3
20 participants
INTERVENTIONAL
2017-10-19
2025-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
BiRd combined with BCMA CAR T-cells infusion
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Age 18-75
3. Eastern Cooperative Oncology Group (ECOG) score 0-2
4. BCMA positive as detected with flowcytometry or ELISA.
5. Patients with left ventricular ejection fraction ≥ 0.5 by echocardiography or grade I/II cardiovascular dysfunction according to the New York Heart Association Classification.
6. Patients with aspartate aminotransferase or glutamic-pyruvic transaminase \> 3x upper limit of normal or bilirubin \> 2.0 mg/dL
Exclusion Criteria
2. Nonsecretory MM.
3. History of previous treatment of MM.
4. Patients with uncontrolled active infection.
5. Patients with active hepatitis B or hepatitis C infection.
6. Patients with HIV infection.
7. Patients with atrial or venous thrombosis or embolism.
8. Patients with myo-infarction or severe arrythmia in the recent 6 months.
9. Other comorbidities that investigators considered not suitable for this study.
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Changshu Frist People's Hospital
UNKNOWN
The Second People's Hospital of Huai'an
OTHER
Affiliated Hospital of Jiangnan University
OTHER
Jiangsu Province Hospital of Traditional Chinese Medicine
OTHER
Jiangyin People's Hospital
OTHER
Jingjiang People's Hospital
OTHER
The Third People's Hospital of Kunshan
UNKNOWN
Lianyungang Hospital Affiliated Bengbu Medical College
OTHER
Suzhou Municipal Hospital
OTHER
Zhangjiagang First People's Hospital
OTHER
Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd
INDUSTRY
The First Affiliated Hospital with Nanjing Medical University
OTHER
Nanjing Medical University
OTHER
The First Affiliated Hospital of Soochow University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Xiaowen Tang, Ph.D
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital of Soochow University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
BiRd-01
Identifier Type: -
Identifier Source: org_study_id