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Multiple MyelomaPhase 2NCT05900882

SVRd for the Treatment of Newly Diagnosed Multiple Myeloma Patients Presenting With Extramedullary Disease

A Phase 2 study testing Selinexor, Bortezomib and Lenalidomide in people with Multiple Myeloma, run by The First Affiliated Hospital with Nanjing Medical University at 6 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate the efficacy and safety of SVRd in NDMM patients presenting with extramedullary disease. 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?
Selinexor, Bortezomib and Lenalidomide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
6 sitesChina
Study dates
15 Jul 2022to 30 Aug 2026
Phase
Phase 2
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

  • Men and women aged with18-75 years old.
  • Confirmed diagnosis of Multiple Myeloma(MM) (IMWG consensus guidelines)
  • Newly diagnosed patients presenting with extramedullary disease (EMD) including solely paraskeletal plasmacytoma, plasmacytoma of soft tissue and other special sites detected by physical exam and confirmed by CT/MRI/PET-CT and/or biopsy (≥2cm).
  • ANC≥1.0*10^9/L, HGB≥75*10^9/L, PLT≥50*10^9/L (≥50% of bone marrow nucleated cells are plasma cells).
  • Patients whose expecting survival time will be more than 3 months.
  • Without active infectious disease.
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  • Female patients of child-bearing potential must have a negative serum pregnancy test at screening and all patients agree to use two reliable methods of contraception for six months after their last dose of medication.
  • Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other study procedures.
  • Each patient must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and are willing to participate in the study.

Who cannot join

  • Patients who have HBV, HCV, and other acquired and congenital immunodeficiency diseases.
  • Patients who have grade 2 or higher of peripheral neuropathy or neuralgia according to the definition of NCI CTCAE version 4.0.
  • Plasma cell leukemia.
  • Serious thrombotic events.
  • Active, unstable cardiovascular dysfunction: a. symptomatic ischemia; b. Uncontrolled, clinically significant conduction abnormalities (except antiarrhythmic ventricular tachycardia), but patients with first-degree atrioventricular block or asymptomatic left anterior bundle/right fascicular block cannot be excluded. c. New York Heart Association (NYHA) Class III - IV or left ventricular ejection fraction (LVEF) <40%; d. Myocardial infarction Within 3 months before C1D1.
  • Significant hepatic dysfunction (ALT and AST ≥ 3 times the upper limit of normal (ULN)).
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  • Serum bilirubin≥1.5 × ULN.
  • creatinine clearance <30 ml/min.
  • History of active malignancy during the past 5 years with the exception of basal carcinoma of the skin or stage 0 cervical carcinoma.
  • Previous major operation within 30 days before C1D1.
  • Patients who have epilepsy, dementia requiring medication, or other mental disorders who are unable to understand or adhere to the study protocol.
  • According to the study protocol or in the opinion of the investigator,serious physical or mental illness that is likely to interfere with the study procedures/results.
  • Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
  • Current participation in another clinical trial.
  • Pregnant or lactating women.
  • Patients with other commodities that the investigators considered not suitable for the enrollment.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

China6 sites

  • Changzhou Second People's Hospital

    Changzhou, Jiangsu, 213000

  • Nanjing First People's Hospital

    Nanjing, Jiangsu, 210000

  • The First Affiliated Hospital of Nanjing Medical University

    Nanjing, Jiangsu, 210029

  • Affiliated Hospital of Nantong University

    Nantong, Jiangsu, 226001

  • Taizhou People's Hospital

    Taizhou, Jiangsu, 225300

  • Yancheng First People's Hospital

    Yancheng, Jiangsu, 224006

Other trials in China

About this study

Official title: An Open Label, Single Arm, Multi-Center Exploratory Study to Evaluate the Efficacy and Safety of SVRd for the Treatment of Newly Diagnosed Multiple Myeloma Patients Presenting With Extramedullary Disease.

The purpose of this study is to evaluate the efficacy and safety of SVRd in NDMM patients presenting with extramedullary disease.

Read the detailed description

Study Design:

This protocol corresponds to a multicenter, open-label, single arm, exploratory study designed to determine the safety of the combination of selinexor combined with VRd in NDMM patients presenting with EMD. The patients who respond to this combination treatment will undergo allogeneic hematopoietic stem cell transplantation or no ASCT and followed by consolidation and maintenance treatment.

All patients will receive 4 courses of SVRd induction therapy, each cycle of treatment will compromise 4 weeks of Selinexor 60mg QW treatment. Transplantation could be performed after 2 courses of VRd consolidation therapy. If not receive transplantation will give 4 cycles of SVRd consolidation therapy. Maintenance treatment will continued for a maximum of 2 years.

Study design allows 35 patients. Induction treatment will consist of Selinexor 60 mg/day orally on d1,8,15,22, Bortezomib 1.3mg/m2 intravenously on d1,8,15,22, Lenalidomide 25 mg/d ( the dose will be adjusted according to creatinine clearance), orally on days 1 to14, Dexamethasone 20 mg/day orally on d1-2, d8-9,d15-16,d22-23

Being tested
Selinexor, Bortezomib, Lenalidomide, Dexamethasone
Keywords
NDMM, Extramedullary disease, SVRd
Medical subject headings
Multiple Myeloma

What participants receive

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

  • SelinexorDrug

    Also called S

    Selinexor 60 mg/day, orally on d1,8,15,22

  • BortezomibDrug

    Also called V

    Bortezomib 1.3mg/m2 intravenously on d1,8,15,22

  • LenalidomideDrug

    Also called R

    Lenalidomide 25 mg/d (the dose will be adjusted according to creatinine clearance)

  • DexamethasoneDrug

    Also called d

    Dexamethasone 20 mg/day orally on d1-2, d8-9,d15-16,d22-23

Study groups in NCT05900882
Study groupRoleWhat they receive
study groupExperimentalSVRd induction treatment
Receives: Drug: Selinexor; Drug: Bortezomib; Drug: Lenalidomide; Drug: Dexamethasone

What is being measured

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

  1. Number of Participants With Overall Response Rate (ORR)

    ORR: defined as the proportion of patients who will achieve PR or better, as per IMWG criteria.

    Measured: End of induction treatment (4 cycles, each cycle is 28 days)

Secondary outcomes (5)

  1. Number of Participants With Complete Response Rate (CR)

    CR: defined as the proportion of patients who will achieve CR, as per IMWG criteria.

    Measured: End of induction treatment (4 cycles, each cycle is 28 days)

  2. Duration of Response (DOR)

    DOR: defined as time, in months, from initial response (PR or better) until the date of a disease progression event

    Measured: 5 years

  3. Progression-Free Survival (PFS)

    PFS: was calculated from the time of informed consent to the date of recurrence or death, whichever occurred first. Patients were censored at the date of the last follow-up visit if they were alive without relapse.

    Measured: 5 years

  4. Overall Survival (OS)

    OS was calculated from the date of informed consent to the date of death. Patients still alive at the end of follow-up were censored at the last date of follow-up.

    Measured: 5 years

  5. Number of adverse events

    Adverse events are evaluated with CTCAE V5.0.

    Measured: During of induction treatment (4 cycles, each cycle is 28 days)

Timeline

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

  1. First posted13 Jun 2023
  2. Study start15 Jul 2022
  3. Primary completion30 Aug 2026
  4. Study completion30 Aug 2026

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
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05900882
Sponsor's protocol ID
SVRd
Status last verified
Aug 2024
First submitted
29 May 2023
Last updated
2 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Jin Y, Cheng X, Zhang X, Shi Q, Zhu Y, Li J, Fan L, Chen L. Efficacy and safety of selinexor combined with VRD in newly diagnosed multiple myeloma with EMD: a phase 2 trial. Blood Adv. 2026 Mar 24;10(6):2016-2022. doi: 10.1182/bloodadvances.2025018945.

    PubMed 41564431

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Selinexor, Bortezomib and Lenalidomide in people with Multiple Myeloma, run by The First Affiliated Hospital with Nanjing Medical University at 6 sites 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 16 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: finished, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Number of Participants With Overall Response Rate (ORR) (time frame: End of induction treatment (4 cycles, each cycle is 28 days)). 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 NCT05900882, 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 2 Sep 2026.

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