Multiple MyelomaPhase 3NCT04287660
Study of BiRd Regimen Combined With BCMA CAR T-cell Therapy in Newly Diagnosed Multiple Myeloma (MM) Patients
A Phase 3 study testing clarithromycin, lenalidomide, dexamethasone and autologous BCMA-directed CAR T-cells in people with Multiple Myeloma, run by The First Affiliated Hospital of Soochow University at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- clarithromycin, lenalidomide, dexamethasone and autologous BCMA-directed CAR T-cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 19 Oct 2017to 31 Jan 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006
Xiaowen Tang, Ph.D, 86-512677801856, xwtang1020@163.com
About this study
Official title: 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
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
Read the 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.
- Conditions
- Multiple Myeloma
- Being tested
- clarithromycin, lenalidomide, dexamethasone and autologous BCMA-directed CAR T-cells
- Keywords
- BiRd, CART, BCMA, MM
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clarithromycin, lenalidomide, dexamethasone and autologous BCMA-directed CAR T-cellsDrug
- 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 group | Role | What they receive |
|---|---|---|
| BiRd combined with BCMA CAR T-cells infusion | Experimental | Not described Receives: Drug: clarithromycin, lenalidomide, dexamethasone and autologous BCMA-directed CAR T-cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks after CAR T-cells infusion (up to 14 weeks)
Secondary outcomes (4)
Overall survival (OS)
time from enrollment to the date of death from any cause
Measured: 4 years
Event-free survival (EFS)
time from enrollment to the date of primary refractory disease, or relapse from sCR, or CR, or death from any cause
Measured: 4 years
Cumulative incidence of relapse(CIR)
time from the date of achievement of a remission until the date of relapse
Measured: 4 years
Number of adverse events
adverse events are evaluated with CTCAE V5.0
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2020
- Study start19 Oct 2017
- Primary completion31 Jan 2023 (estimated)
- Study completion31 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Soochow UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- 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, Nanjing Medical University
- Responsible party
- Sponsor
- Investigators
- Xiaowen Tang, Ph.D, Principal investigator, The First Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04287660
- Sponsor's protocol ID
- BiRd-01
- Status last verified
- Feb 2021
- First submitted
- 19 Feb 2020
- Last updated
- 25 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04287660
- Acronym / sponsor ID
- BiRd-01
- Conditions
- Multiple Myeloma
- Keywords
- BiRd, CART, BCMA, MM
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Collaborators
- 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, Nanjing Medical University
- Study start
- 19 Oct 2017 (actual)
- Primary completion
- 31 Jan 2023 (estimated)
- Study completion
- 31 Jan 2025 (estimated)
- First posted
- 27 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BiRd combined with BCMA CAR T-cells infusion | Experimental | Drug: clarithromycin, lenalidomide, dexamethasone and autologous BCMA-directed CAR T-cells |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | BiRd combined with BCMA CAR T-cells infusion |
Primary outcome
Overall response rate (ORR)
Time frame: 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.
4 secondary outcomes
Overall survival (OS)
Time frame: 4 years
Event-free survival (EFS)
Time frame: 4 years
Cumulative incidence of relapse(CIR)
Time frame: 4 years
Number of adverse events
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiaowen Tang, Ph.D principal investigator
The First Affiliated Hospital of Soochow University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing clarithromycin, lenalidomide, dexamethasone and autologous BCMA-directed CAR T-cells in people with Multiple Myeloma, run by The First Affiliated Hospital of Soochow University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaowen Tang, Ph.D (86-512677801856, xwtang1020@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate (ORR) (time frame: 4 weeks after CAR T-cells infusion (up to 14 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2021.