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Multiple MyelomaPhase 2NCT04877275

ATG-010(Selinexor) in Combination With Chemotherapy in RRMM

A Phase 2 study testing Selinexor (80mg/d), Selinexor (100mg/d) and Pegylated liposomal doxorubicin in people with Multiple Myeloma, run by Chunyan Sun, MD at 5 sites 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 The sponsor has not verified this record for over two years, so it may be out of date.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

This is a single-arm that includes two experimental arms,Selinexor(ATG-010) in Combination with Chemotherapy to Treat Relapsed/Refractory Multiple Myeloma Patients.To evaluate efficacy and safety of ATG-010 in combination with chemotherapy in RRMM patients received at least one prior lines of therapy 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 (80mg/d), Selinexor (100mg/d) and Pegylated liposomal doxorubicin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
5 sitesChina
Study dates
21 May 2021to 30 Dec 2024
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) ≥ 5 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 platelet transfusion within 2 weeks prior to screening test):
  • Hemoglobin level ≥ 60 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 combined drugs.
  • 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.
  • 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 3 weeks or 5 half-lives (T1/2) （With a short time priority） prior to the first study.
  • Prior exposure to a SINE compound.

Trial locations and contacts

5 sites in 1 country.

Chunyan Sun, M.D., Ph.D contact

13237183940

suncy0618@163.com

Hongwei Li, MSc contact

18205191049

cpu_473lhw@126.com

5 sites in 1 country

China5 sites, 5 recruiting

  • Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology

    Wuhan, Hubei, 430022

    Chunyan Sun, M.D.,Ph.d, 13237183940, suncy0618@163.com

    Chunyan Sun, M.D.,Ph.d

    Recruiting

  • Zhongnan Hospital of Wuhan University

    Wuhan, Hubei, 430071

    Fuling Zhou, Ph.D

    Not yet recruiting

  • The First Affiliated Hospital of Air Force Medical University

    Xi’an, Shanxi, 710000

    Guangxun Gao, PhD

    Not yet recruiting

  • The Second Affiliated Hospital of Xi'an Jiaotong University

    Xi’an, Shanxi, 710004

    Aili He, Ph.D

    Not yet recruiting

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450000

    Baijun Fang, Ph.D

    Recruiting

Other trials in China

About this study

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

This is a single-arm that includes two experimental arms,Selinexor(ATG-010) in Combination with Chemotherapy to Treat Relapsed/Refractory Multiple Myeloma Patients.To evaluate efficacy and safety of ATG-010 in combination with chemotherapy 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 two experimental arms. Arm I is given XDd regimen (ATG-010 80mg/d QW, Pegylated liposomal doxorubicin 25mg/m2, d1and Dexamethasone 40mg/d QW) in approximately 25 subjects. Arm II is given XCd regimen (ATG-010 100mg/d QW, Cyclophosphamide 300mg/m2, d1and Dexamethasone 40mg/d QW). Both arms are 4 weeks per cycle and include a total of 12 cycles.

Being tested
Selinexor (80mg/d), Selinexor (100mg/d), Pegylated liposomal doxorubicin, Dexamethasone, Cyclophosphamide
Keywords
Selinexor, ATG-010, Multiple Myeloma, Relapsed/Refractory Multiple Myeloma
Medical subject headings
Multiple Myeloma

What participants receive

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

  • Selinexor (80mg/d)Drug

    Also called ATG-010

    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.

    Arm I：80mg/d QW ;

  • Selinexor (100mg/d)Drug

    Also called ATG-010

    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.

    Arm II：100mg/d QW ;

  • Pegylated liposomal doxorubicinDrug

    Also called PLD

    25 mg/m^2 intravenously on day 1 , QW

  • DexamethasoneDrug

    Also called Dex

    Dexamethasone 40mg/d QW

  • CyclophosphamideDrug

    Also called CTX

    Cyclophosphamide：300mg/m2, d1 QW，

Study groups in NCT04877275
Study groupRoleWhat they receive
Arm I: Selinexor+Pegylated liposomal doxorubicin +DexamethasoneExperimentalArm I is given XDd regimen (ATG-010(Selinexor) 80mg/d QW, Pegylated liposomal doxorubicin 25mg/m2, d1and Dexamethasone 40mg/d QW) in approximately 25 subjects. 4 weeks per cycle and include a total of 12 cycles.
Receives: Drug: Selinexor (80mg/d); Drug: Pegylated liposomal doxorubicin; Drug: Dexamethasone
Arm II: Selinexor+Cyclophosphamide+DexamethasoneExperimentalArm II is given XCd regimen (ATG-010 100mg/d QW, Cyclophosphamide 300mg/m2, d1and Dexamethasone 40mg/d QW). 4 weeks per cycle and include a total of 12 cycles.
Receives: Drug: Selinexor (100mg/d); Drug: Dexamethasone; Drug: Cyclophosphamide

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 posted7 May 2021
  2. Study start21 May 2021
  3. Primary completion30 Dec 2024 (estimated)
  4. Study completion30 Dec 2024 (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
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04877275
Sponsor's protocol ID
ATG-010-IIT-MM-002
Status last verified
Dec 2023
First submitted
27 Apr 2021
Last updated
6 Dec 2023
Results posted
No
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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Selinexor (80mg/d), Selinexor (100mg/d) and Pegylated liposomal doxorubicin in people with Multiple Myeloma, run by Chunyan Sun, MD at 5 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 23 inclusion and 24 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 6 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 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?

Results are not available in the source record.

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

Contact Chunyan Sun, M.D., Ph.D (13237183940, suncy0618@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 NCT04877275.

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 6 Dec 2023.

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