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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04287660

Enrollment

Registered

2020-02-27

Start date

2017-10-19

Completion date

2025-01-31

Last updated

2021-10-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Myeloma

Keywords

BiRd, CART, BCMA, MM

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

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.

Interventions

DRUGclarithromycin, 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

China

Contacts

Primary ContactXiaowen Tang, Ph.D

xwtang1020@163.com86-512677801856

Backup ContactDepei Wu, Ph.D

drwudepei@163.com86-512677801856

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026