Study of BiRd Regimen Combined With BCMA CAR T-cell Therapy in Newly Diagnosed Multiple Myeloma (MM) Patients

• Status: Recruiting
• Trial end date: 2025-01-31
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The First Affiliated Hospital of Soochow University
• Collaborators: Affiliated Hospital of Jiangnan University; Changshu Frist People's Hospital; Huai'an Second People's Hospital; Jiangsu Province Hospital of Traditional Chinese Medicine; Jiangyin People's Hospital; Jingjiang People's Hospital; Lianyungang Hospital Affiliated Bengbu Medical College; Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd; Suzhou Municipal Hospital; The first Affiliated Hospital of Nanjing University Medical School; The First Affiliated Hospital with Nanjing Medical University; The Third People's Hospital of Kunshan; Zhangjiagang First People's Hospital
• Treatments: BB 1101; Clarithromycin; Dexamethasone; Dexamethasone acetate; Lenalidomide

Criteria

Inclusion Criteria:

1. Newly diagnosed MM according to the criteria by International Myeloma Working Group (IMWG)

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:

1. Patients are pregnant or lactating.

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.