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Multiple MyelomaPhase 2NCT04941937

Selinexor in Combination With Immunomodulator （Thalidomide/Pomalidomide/Lenalidomide）in RRMM

A Phase 2 study testing Selinexor, Thalidomide and Lenalidomide in people with Multiple Myeloma, run by Juan Du at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Multiple myeloma (MM) is an incurable plasma cell cancer that almost all patients eventually relapse despite advancement in treatment strategies. B-cell maturation antigen (BCMA) is a cell surface receptor that expressed primarily by malignant and normal plasma cells. 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, Thalidomide and Lenalidomide
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteChina
Study dates
27 Jan 2022to 30 Dec 2025
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

  • Patients must meet all of the following inclusion criteria to be eligible to enroll in this study:
  • Known and written informed consent (ICF) voluntarily.
  • Age ≥ 18 years and ≤ 75 years.
  • Patients with multiple myeloma who have received first-line treatment (induction, autologous transplantation and maintenance as the same first-line treatment) and achieved at least partial remission in induction.
  • At or after accepting first-line regimen, subjects must have progression disease (PD) recorded which is determined by researcher according to IMWG criteria.
  • Any clinically significant non-hematological toxicities (except for hair loss, peripheral neuropathy, which is otherwise stipulated in Article 13 of the exclusion criteria) that relevant to previous therapies must have resolved to ≤Grade 2 prior to first dose of study drug.
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  • Left ventricular ejection fraction#LVEF #≥50% by an echocardiogram or MUGA scan in 42 days before the first administration
  • Adequate hepatic function: total bilirubin < 2× upper limit of normal (ULN) (for patients with Gilbert's syndrome, a total bilirubin of < 3× ULN is required), AST < 2.5× ULN, and ALT < 2.5× ULN.
  • Adequate renal function: estimated creatinine clearance ≥ 20 mL/min (calculated using the formula of Cockroft-Gault).
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2.
  • Measurable MM as defined by at least one of the following:
  • Serum M-protein (SPEP) ≥ 10 g/L
  • 24 hours-Urinary M-protein excretion ≥ 0.2 g (200 mg)
  • Serum FLC ≥ 100 mg/L with abnormal FLC ratio
  • Expected survival is more than 6 months.
  • Adequate hematopoietic function (no blood transfusion within 2 weeks and no G-CSF/GM-CSF supportive treatment within 1 week prior to screening test):
  • Hemoglobin level ≥ 80 g/L
  • ANC ≥ 1,000/mm3 (1.0×109/L)
  • Platelet count ≥ 75,000/mm3 (75×109/L)
  • Female patients of childbearing potential must meet below two criteria:
  • must agree to use effective contraception methods since signature in ICF, throughout the study and for 3 months following the last dose of study treatment.
  • must have a negative serum pregnancy test at screening. Note: A woman is considered of childbearing potential following menarche and until becoming postmenopausal (defined as no menstrual period for a minimum of 12 months) or permanently sterile (having undergone a hysterectomy, bilateral salpingectomy or bilateral oophorectomy). A woman who is taking oral contraceptive or using intrauterine device is considered of childbearing potential.
  • Male patients (including those who have received vasectomy) must use a condom if sexually active with a female of child-bearing potential throughout the study and for 3 months following the last dose of study treatment.

Who cannot join

  • Patients who meet any of the following criteria will not be enrolled:
  • Asymptomatic (smoldering) MM.
  • Plasma cell leukemia.
  • Documented active amyloidosis.
  • Previously refractory or intolerant to immunomodulators.
  • Pregnancy or breastfeeding.
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  • Major surgery was performed within 4 weeks prior to the first study.
  • Patients with active, unstable cardiovascular diseases, fits any of the following:
  • Symptomatic ischemia, or
  • Uncontrolled clinically-significant conduction abnormalities (e.g., patients with ventricular tachycardia on antiarrhythmics are excluded; patients with first-degree atrioventricular (AV) block or asymptomatic left anterior fascicular block/right bundle branch block (LAFB/RBBB) are allowed), or
  • Congestive heart failure (CHF) of New York Heart Association (NYHA) ≥ Grade 3, or
  • Acute myocardial infarction (AMI) within 3 months prior to the first dose of study drug.
  • Uncontrolled active infection within 1 week prior to the first dose of study drug.
  • Known HIV positive.
  • Known active hepatitis A, B, or C infection; or known positive for HCV RNA or HBsAg. (Note: patients with HBsAg negative but HBc Ab positive need further HBV-DNA test, excluded if HBV-DNA ≥103 , if HBV-DNA # 103 need anti-viral drugs)
  • Prior malignancy that required treatment or has shown evidence of recurrence (except for skin basal-cell carcinoma and in-situ carcinoma including squamous cell carcinoma, bladder cancer in situ, endometrial cancer in situ, cervical cancer in situ/atypical hyperplasia, prostate cancer incidental finding (T1a or T1b), or breast cancer in situ) within 5 years prior to the first dose of study drug.
  • Active GI dysfunction interfering with the ability to swallow tablets, or any GI dysfunction that could interfere with absorption of study treatment.
  • Grade ≥ 3 peripheral neuropathy, and Grade ≥ 2 painful neuropathy, within 3 weeks prior to the first dose of study drug.
  • Previous history of deep vein thrombosis.
  • Serious, active psychiatric, or medical conditions which, in the opinion of the Investigator, could interfere with study treatment.
  • Participation in an investigational anti-cancer clinical study within 3 weeks or 5 half-lives (T1/2) prior to the first dose of study drug.
  • Received ASCT within 12 weeks prior to the first dose of study drug or previous allogeneic stem cell transplantation (no time limitation).
  • Treatment with an approved or trial anticancer drug was given within 4 weeks prior to the first study.
  • Known intolerance to or contraindication for glucocorticoid therapy.
  • Prior exposure to a SINE compound.

Trial locations and contacts

1 site in 1 country.

Juan Du, M.D., Ph.D contact

15800706091

Changzheng_pg@163.com

Hongwei Li, MSc contact

18205191049

cpu_473lhw@126.com

China1 site, 1 recruiting

  • Shanghai Changzheng Hospital

    Shanghai, Shanghai Municipality, 200003

    Juan Du, PhD, 8615800706091 ext. 8615800706091, changzheng_pg@163.com

    Ziliang Qian, PhD, ziliang.qian@prophetgenomics.com.cn

    Recruiting

Other trials in China

About this study

Official title: Selinexor in Combination With Immunomodulator to Treat Relapsed/Refractory Multiple Myeloma Patients

Multiple myeloma (MM) is an incurable plasma cell cancer that almost all patients eventually relapse despite advancement in treatment strategies. B-cell maturation antigen (BCMA) is a cell surface receptor that expressed primarily by malignant and normal plasma cells. This is a single-arm that includes three arms, Selinexor(ATG-010) in Combination with Immunomodulator (Thalidomide/ Pomalidomide/ Lenalidomide）and Dexamethasone to Treat Relapsed/Refractory Multiple Myeloma Patients. To evaluate efficacy and safety of Selinexor in combination with Immunomodulator and Dexamethasone in RRMM patients received at least one prior lines of therapy.

Read the detailed description

This is a single-arm and open-label phase II study of Relapsed/Refractory Multiple Myeloma patients who have received at least one prior lines of treatment therapy; This study includes three experimental arms. Arm I is given XTd regimen (ATG-010 60mg/d QW, Thalidomide 100mg/d and Dexamethasone 40mg/d QW) in approximately 30 subjects. Arm II is given XRd regimen (ATG-010 60mg/d QW, Lenalidomide 25mg/d d1-21 and Dexamethasone 40mg/d QW) in approximately 30 subjects, Arm III is given XPd（ATG-010 60mg/d QW, Pomalidomide 4mg/d d1-21 and Dexamethasone 40mg/d QW ) in approximately 30 subjects,The three arms are 4 weeks per cycle and include a total of 12 cycles.

Keywords
Selinexor（ATG-010）, Multiple Myeloma, Relapsed/Refractory Multiple Myeloma, Thalidomide, Pomalidomide, Lenalidomide
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 ATG-010/KPT-330

    Selinexor (ATG-010# is a first-in-class, oral selective exportin 1 (XPO1) inhibitor (1,2). Selinexor functions by binding with and inhibiting the nuclear export protein XPO1 (also called CRM1), leading to the accumulation of tumor suppressor proteins in the cell nucleus along with inhibition of translation of oncoprotein mRNAs. Selinexor 60mg/d QW

  • ThalidomideDrug

    Also called fǎn yìng tíng

    100mg/d, Po. on day1-28

  • LenalidomideDrug

    Also called Revlimid, An xian

    PO,Lenalidomide 25mg once daily from D1-21

  • PomalidomideDrug

    Also called POMALYST

    Pomalidomide will be given at 4mg once daily for 21 days in a 28-day cycle, PO.

  • DexamethasoneDrug

    Also called Dex

    Dexamethasone will be given at a dose of 40mg orally once a week for 4 weeks (D1,8,15,22).

Study groups in NCT04941937
Study groupRoleWhat they receive
Arm I: Selinexor+Thalidomide+DexamethasoneExperimentalArm I is given XTd regimen Selinexor 60mg/d QW, Thalidomide 100mg/d, d1-28 and Dexamethasone 40mg/d QW) in approximately 30 subjects. 4 weeks per cycle and include a total of 12 cycles.
Receives: Drug: Selinexor; Drug: Thalidomide; Drug: Dexamethasone
Arm II: Selinexor+Lenalidomide+DexamethasoneExperimentalArm II is given XRd regimen Selinexor 60mg/d QW, Lenalidomide 25mg/d, d1-21 and Dexamethasone 40mg/d QW) in approximately 30 subjects. 4 weeks per cycle and include a total of 12 cycles.
Receives: Drug: Selinexor; Drug: Lenalidomide; Drug: Dexamethasone
Arm III: Selinexor+Pomalidomide+DexamethasoneExperimentalArm III is given XPd regimen Selinexor 60mg/d QW, Pomalidomide 4mg/d, d1-21 and Dexamethasone 40mg/d QW) in approximately 30 subjects. 4 weeks per cycle and include a total of 12 cycles.
Receives: Drug: Selinexor; Drug: Pomalidomide; Drug: Dexamethasone

What is being measured

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

  1. Overall Response Rate (ORR)

    ORR in each arm: partial response (PR) + very good partial response (VGPR) + complete response (CR)

    Measured: Assessed from the date of first dose of study treatment until the date that PD assessed up to 12months

Secondary outcomes (7)

  1. Minimal Residual Disease (MRD)

    To evaluate the minimal residual disease in CR and sCR patients

    Measured: 12 months

  2. Overall Survival (OS)

    The estimates of Kaplan-Meier

    Measured: 12 months

  3. Progression-Free Survival (PFS)

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

    Measured: 12 months

  4. Duration of Response (DOR)

    Duration from the first observation of at least PR to time of disease progression, or deaths due to disease progression,whichever occurs first.

    Measured: 12 months

  5. Clinical Benefit Rate (CBR)

    Clinical Benefit Rate (CBR=ORR+Minor Response [MR])

    Measured: 12 months

  6. Disease Control Rate (DCR)

    Disease Control Rate (DCR=CBR+Stable Disease[SD; for a minimum of 12 weeks])

    Measured: 12 months

  7. Number of Participants with Adverse Events

    Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)

    Measured: From first dose of study drug administration to end of treatment (up to 12 months)

Timeline

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

  1. First posted28 Jun 2021
  2. Study start27 Jan 2022
  3. Primary completion30 Dec 2025 (estimated)
  4. Study completion30 Dec 2025 (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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04941937
Sponsor's protocol ID
ATG-010-IIT-MM-004
Status last verified
Feb 2023
First submitted
25 Jun 2021
Last updated
27 Feb 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: All IPD results are used for publication,and can be shared with other investigators and sponsors

Publications

  • Peng L, Shan T, Zhou X, Feng Z, Qiang W, Lu J, He H, Du J. Lowering the Selinexor Dose within the Pomalidomide and Dexamethasone Combination Regimen Elicits Fewer Side Effects While Comparable Efficacy Against Relapsed/Refractory Multiple Myeloma. Onco Targets Ther. 2025 Jun 6;18:695-703. doi: 10.2147/OTT.S516486. eCollection 2025.

    PubMed 40496494

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Selinexor, Thalidomide and Lenalidomide in people with Multiple Myeloma, run by Juan Du 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 23 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: status not confirmed, as of the sponsor's last update on 27 Feb 2023. 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?

Results are not available in the source record.

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

Contact Juan Du, M.D., Ph.D (15800706091, Changzheng_pg@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: Assessed from the date of first dose of study treatment until the date that PD assessed up to 12months). 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 NCT04941937, 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 27 Feb 2023.

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