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Multiple MyelomaPhase 2NCT05860036

A Study of VRd-based Regimen Followed by BCMA CAR-T Therapy in Transplant-Ineligible Patients With New-diagnosed Multiple Myeloma

A Phase 2 study testing anti-BCMA CAR-T and VRd 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 BCMA CAR-T in Chinese transplant-ineligible patients with newly diagnosed multiple myeloma 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?
anti-BCMA CAR-T and VRd
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteChina
Study dates
4 Apr 2023to 10 Mar 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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years and ≤ 75 years.
  • Participants with documented NDMM according to IMWG diagnostic criteria.
  • Measurable disease, at screening as defined by any of the following: Serum monoclonal paraprotein (M-protein) level ≥1.0 g/dL or urine M-protein level ≥200 mg/24 hours; or Light chain MM without measurable disease in serum or urine: serum Ig free-light chain (FLC) ≥10 mg/dL and abnormal serum Ig kappa lambda FLC ratio.
  • Not considered for high-dose chemotherapy with Autologous Stem Cell Transplant (ASCT) due to: Ineligible due to advanced age (≥65); or Ineligible evaluated by researchers; or Eastern Cooperative Oncology Group Performance Status grade of 3 or 4; or Repeated hematopoietic stem cell mobilization failure；or Deferral of high-dose chemotherapy with ASCT as initial treatment.
  • Bone marrow sample is confirmed as BCMA-positive by flow cytometry or pathological examination.
  • 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<2 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 ≥ 30mL/min (calculated using Cockroft-Gault formula).
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  • 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 ≥ 70 g/L PLT ≥ 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.

Who cannot join

  • Primary plasma cell leukemia.
  • Documented active amyloidosis.
  • Multiple myeloma with central nervous system (CNS) invasion.
  • Prior exposure to any BCMA-targeted therapy or CAR-T therapy.
  • 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 glucocorticoids, bortezomib, lenalidomide, and BCMA-CART cellular products.
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  • Seropositive for human immunodeficiency virus (HIV)
  • Hepatitis B infection
  • Hepatitis C infection
  • Life expectancy of <6 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 judgment, 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: Safety and Efficiency of VRd-based Regimen Followed by BCMA CAR-T for New-diagnosed Transplant-ineligible Multiple Myeloma Patients: a Prospective, Single-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 BCMA CAR-T in Chinese transplant-ineligible patients with newly diagnosed multiple myeloma

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 VRd (Bortezomib, Lenalidomide and Dexamethasone)-based regimen combined with BCMA CAR-T in Chinese transplant-ineligible patients with newly diagnosed multiple myeloma. Patients received 3 courses of induction therapy with VRd-based regimen followed by infusion of BCMA CAR-T cells. Patients then received 3 courses of VR-based consolidation therapy, followed by R maintenance therapy.

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

  • VRdDrug

    Bortezomib, Lenalidomide and Dexamethasone

Study groups in NCT05860036
Study groupRoleWhat they receive
VRd-based regimen Combined With BCMA CARTExperimentalVRd：Bortezomib, Lenalidomide and Dexamethasone Bortezomib SC 1.3mg/sqm on day 1,8,15,22, Lenalidomide oral 25 mg on day 1-21, and Dexamethasone 40mg on day 1,8,15,22 in a 28-day cycle. Autologous BCMA-directed CAR-T cells, infusion intravenously at a target dose of 2-4 x 10^6 anti-BCMA CAR+T cells/kg. Participants will receive VRD induction, BCMA CAR-T infusion, VR consolidation, R maintenance.
Receives: Biological: anti-BCMA CAR-T; Drug: VRd

What is being measured

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

  1. Safety and Tolerability

    The incidence of treatment-emergent adverse events (TEAEs)

    Measured: Up to 2 year

  2. MRD-negative rate

    achieving MRD-negative, as determined by NGS/NGF 3 months after CAR-T cell infusion

    Measured: 3 months after CAR-T cell infusion

Secondary outcomes (4)

  1. Complete response rate (CRR)

    CR or better is defined as percentage of participants who achieve a CR response or Stringent Complete Response (sCR) response accoording to the IMWG criteria

    Measured: within 1 week after induction therapy, 1 month after the CAR-T cell transfusion, within 1 week after consolidation therapy

  2. Progression free survival (PFS)

    Progression free survival is defined as the time from the date of diagnosis to the date of first documented PD, as defined in the IMWG criteria, or death due to any cause, whichever occurs first

    Measured: Up to 2 year

  3. Overall Survival (OS)

    Overall survival is measured from the date of diagnosis to the date of the participant's death.

    Measured: Up to 5 year

  4. 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: Up to 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 posted16 May 2023
  2. Study start4 Apr 2023
  3. Primary completion1 Jun 2025
  4. Study completion10 Mar 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
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05860036
Sponsor's protocol ID
IIT2022073
Status last verified
Jul 2025
First submitted
3 Apr 2023
Last updated
3 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Yan W, Du C, Lv R, Zou H, Zhang S, Yu T, Yan Y, Zhang Y, Peng S, Wang T, Deng S, Huang W, Yi S, Zou D, Cheng T, Wang J, Chang AH, Qiu L, An G. Phase II Study of BCMA Chimeric Antigen Receptor T-Cell Therapy in Patients With Newly Diagnosed Multiple Myeloma Ineligible for or Not Proceeding to Autologous Stem-Cell Transplantation (CAREMM-001). J Clin Oncol. 2026 Apr 10;44(11):992-1002. doi: 10.1200/JCO-25-01969. Epub 2026 Feb 27.

    PubMed 41759038

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing anti-BCMA CAR-T and VRd 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 9 inclusion and 18 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 Aug 2025. 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?

Safety and Tolerability (time frame: Up to 2 year). The study lists 2 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 NCT05860036, which also lists 1 linked publication.

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 Aug 2025.

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