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Multiple MyelomaPhase 2NCT05850286

A Study of VRd-based Regimen Combined With CART-ASCT-CART2 Treatment in NDMM Patients With P53 Abnormalities

A Phase 2 study testing anti-BCMA CAR-T and VRD-based Regimen in people with Multiple Myeloma, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This is a single-arm, open-label study to evaluate the efficacy and safety of VRD(Bortezomib, Lenalidomide and Dexamethasone)-based regimen combined with CART-ASCT-CART2 in patients with newly diagnosed multiple myeloma with p53 gene abnormalities. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Multiple Myeloma
What is being tested?
anti-BCMA CAR-T and VRD-based Regimen
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
21 Apr 2023to Apr 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Willing and able to give written informed consent (ICF) .
  • Age ≥ 18 years and ≤ 65 years.
  • Meet the internationally accepted Criteria for the diagnosis of newly diagnosed multiple myeloma (Chinese guidelines for the diagnosis and management of multiple myeloma (revised in 2022) criteria)
  • Patients have not received previous anti-multiple myeloma-related chemotherapy, have not received previous extensive pelvic radiotherapy (more than half of the pelvic area), and have not received previous anti-multiple myeloma hormone therapy, except for those who have used hormones for no more than 14 days for symptom control.
  • The patient have one or more measurable multiple myeloma lesion, must include one of the following conditions:
  • Serum M protein≥1.0 g/dL(10g/L)
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  • Urine M protein≥200 mg/24h
  • Serum free light chain(sFLC): κ/λ FLC ratio is abnormal and affected FLC ≥10mg / dL
  • p53 gene abnormalities: Plasma cells were enriched by CD138 immunomagnetic and then detected by FISH. Cut-off ≥20%., or P53 mutation by second-generation sequencing.
  • ECOG scores 0 - 1;
  • No active infection
  • All screening blood biochemistry: tests should be performed according to the protocol and within 14 days before enrollment. Screening laboratory values must meet the following criteria： a.TBIL<1.5 x upper limit of normal (ULN) (<3 x ULN in patients with Gilbert's syndrome); b.AST and ALT <3 x ULN.; c. Creatinine clearance ≥ 60mL/min (calculated using Cockroft-Gault formula).
  • normal pulmonary function and oxygen saturation ≥ 92% on room air.
  • Routine blood tests (performed within 7 days, no RBC transfusion, no G-CSF/GM-CSF/platelet agonists, no drug correction within 14 days before screening, no PLT transfusion within 7 days) : WBC ≥ 1.5 x 109/L, ANC ≥ 1.0 x 109/L, Hb ≥ 85 g/L PLY ≥ 75 x 109/L (if BMPC < 50%) or PLT ≥ 50 x 109/L (if BMPC ≥ 50%)
  • Patients must be able to take prophylactic anticoagulant therapy as recommended by the study.
  • The woman is not breastfeeding, is not pregnant and agrees not to be pregnant during the study period and for the following 12 months. Male patients agreed that their spouse would not become pregnant during the study period and for 12 months thereafter.
  • Willing and able to complete the study procedures and follow-up examinations.

Who cannot join

  • Plasma cell leukemia.
  • Documented active amyloidosis.
  • Multiple myeloma with central nervous system (CNS) invasion
  • Unsuitable for autologous stem cell transplantation, such as severe cardiopulmonary disorders
  • Patients with peripheral neuropathy greater than grade 2 or peripheral neuropathy greater than grade 2 with pain at baseline, regardless of whether they were currently receiving medical therapy
  • Known intolerance, hypersensitivity, or contraindication to BCMA-CART cellular products.
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  • Patients with unstable or active cardiovascular system disease, meeting any of the following:
  • Unstable angina pectoris, symptomatic myocardial ischaemia, myocardial infarction or coronary artery reconstruction within 180 days prior to the first dose.
  • Uncontrolled hypertension (>140/90 mmHg with blood pressure fluctuations of more than 180/100 mmHg over a 6-month period).
  • Uncontrolled and clinically significant conduction abnormalities (e.g. patients with ventricular arrhythmias controlled by antiarrhythmic medication), not excluding patients with 1st degree atrioventricular (AV) block or asymptomatic left anterior bundle branch block/right bundle branch block (LAFB/RBBB)).
  • Congestive heart failure (CHF) classification ≥ grade 3 as defined by the New York Heart Association (NYHA).
  • Left ventricular ejection fraction (LVEF) <50% on echocardiography.
  • History of stroke or intracranial haemorrhage within 12 months prior to screening.
  • Presence of a serious thrombotic event prior to treatment.
  • Known positive serology for HIV or HIV seropositivity.
  • Active hepatitis B or C infection. Screening requires serologic testing for hepatitis. If hepatitis B surface antigen and hepatitis B core antibody were positive, a negative DNA polymerase chain reaction (PCR) result was needed before enrollment (after anti-hepatitis B therapy, a negative DNA polymerase PCR result was confirmed before enrollment). If the hepatitis C antibody was positive, the RNA PCR test should be negative prior to enrollment
  • Life expectancy of <3 months
  • Women who are pregnant or breastfeeding
  • Any active gastrointestinal dysfunction that affects the patient's ability to swallow tablets, or any active gastrointestinal dysfunction that may affect the absorption of the studied treatment medication
  • Subjects had major surgery within 2 weeks before randomization (for example, general anesthesia), or is not fully recovered from the surgery, or surgery is arranged during study period.
  • Received live attenuated vaccine within 4 weeks prior to study treatment.
  • According to the researcher's judgement, any condition including but not limited to serious mental illness, medical illness or other symptoms/conditions that may affect study treatment, compliance, or the capability of providing informed consent.
  • Necessary medication or supportive therapy is contraindicated with study treatment.
  • Any diseases or complications that may interfere with the study.
  • Patients are not willing to or cannot comply with study scheme.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences

    Tianjin

Other trials in China

About this study

Official title: VRd-based Regimen Combined With CART-ASCT-CART2 as First-line Therapy for Newly Diagnosed Multiple Myeloma Patients With P53 Abnormalities：a Prospective, One-arm, Single-center Phase II Study

This is a single-arm, open-label study to evaluate the efficacy and safety of VRD(Bortezomib, Lenalidomide and Dexamethasone)-based regimen combined with CART-ASCT-CART2 in patients with newly diagnosed multiple myeloma with p53 gene abnormalities.

Read the detailed description

The study is a prospective, single-arm, single-centre, phase II study designed to evaluate the efficacy and safety of treatment with the VRd (short for Bortezomib, Lenalidomide, Dexamethasone)-based regimen in combination with the CART-ASCT-CART2 in newly diagnosed multiple myeloma patients with P53 gene abnormalities. Patients received 3 courses of induction therapy with VRd-based regimen followed by a first infusion of CAR-T cells. Patients then received 3 courses of consolidation therapy, followed by ASCT and second infusion of CAR-T cells. R maintenance therapy starts on day 100 after ASCT

Being tested
anti-BCMA CAR-T, VRD-based Regimen
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • anti-BCMA CAR-TBiological

    Autologous BCMA-directed CAR-T cells, double infusion intravenously at a target dose of 2.0-4.0 x 10^6 anti-BCMA CAR+T cells/kg.

  • VRD-based RegimenDrug

    Bortezomib, Lenalidomide and Dexamethasone

Study groups in NCT05850286
Study groupRoleWhat they receive
VRD-based Regimen Combined With CART-ASCT-CART2ExperimentalAutologous BCMA-directed CAR-T cells, Double infusion intravenously at a target dose of 2-4 x 10^6 anti-BCMA CAR+T cells/kg respectively. Participants will receive VRD-based regimen induction, first CAR-T infusion, consolidation, ASCT and second CAR-T infusion. Maintenance therapy was initiated on day 100 and entered the follow-up period.
Receives: Biological: anti-BCMA CAR-T; Drug: VRD-based Regimen

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. complete response rate (CRR)

    CRR(including sCR / CR , based on IMWG 2016 efficacy evaluation criteria)

    Measured: after induction therapy, 1 month after the first CAR-T cell transfusion, the consolidation therapy ends, 12 months after the second CAR-T cell transfusion

  2. Overall response rate (ORR)

    ORR(including sCR / CR / VGPR / PR, based on IMWG 2016 efficacy evaluation criteria)

    Measured: after induction therapy, 1 month after the first CAR-T cell transfusion, the consolidation therapy ends, 12 months after the second CAR-T cell transfusion

  3. Negative MRD rate

    Rate of negative minimal residual disease

    Measured: after induction therapy, 1 month after the first CAR-T cell transfusion, the consolidation therapy ends, 12 months after the second CAR-T cell transfusion

  4. Overall Survival (OS)

    Occurrence of death regardless of cause

    Measured: 1 year

  5. Progression free survival (PFS)

    Duration from start of study treatment to PD or death (regardless of cause), whichever comes first

    Measured: 1 year

  6. Duration of Remission(DOR)

    Duration from the first evaluation of at least partial remission (PR) to the onset of disease progression or death due to disease progression (whichever occurs first)

    Measured: 2 year

Secondary outcomes (1)

  1. The incidence of treatment-emergent adverse events (TEAEs)

    The incidence of treatment-emergent adverse events (TEAEs)

    Measured: 2 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 May 2023
  2. Study start21 Apr 2023
  3. Primary completion15 Apr 2026
  4. Study completionApr 2028 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05850286
Sponsor's protocol ID
IIT2022063（2）
Status last verified
Apr 2026
First submitted
28 Apr 2023
Last updated
3 Jun 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing anti-BCMA CAR-T and VRD-based Regimen in people with Multiple Myeloma, run by Institute of Hematology & Blood Diseases Hospital, China 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 17 inclusion and 25 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: under way, not looking for participants, as of the sponsor's last update on 3 Jun 2026. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

complete response rate (CRR) (time frame: after induction therapy, 1 month after the first CAR-T cell transfusion, the consolidation therapy ends, 12 months after the second CAR-T cell transfusion). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05850286.

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 3 Jun 2026; AzTrials last refreshed its copy on 6 Nov 2026.

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