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Multiple MyelomaPhase 1/2NCT04891744

Selinexor in Combination With Thalidomide and Dexamethasone in RRMM

A Phase 1/2 study testing Selinexor, Thalidomide and Dexamethasone in people with Multiple Myeloma, run by Li Zheng 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 The sponsor has not verified this record for over two years, so it may be out of date.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 Dexamethasone
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteChina
Study dates
6 Jul 2021to 30 Dec 2024
Phase
Phase 1/2
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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  • 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.

Hongwei Li, MSc contact

18205191049

cpu_473lhw@126.com

Li Zheng, M.D., Ph.D contact

+86-028-85423655

lzheng2005618@163.com

China1 site

  • West China Hospital of Sichuan University

    Chengdu, Sichuan, 610041

    Hongwei Li, MSc, 18205191049, cpu_473lhw@126.com

    Li Zheng, MD.PhD, +86-028-85423655, lzheng2005618@163.com

Other trials in China

About this study

Official title: Phase Ib/II Study of ATG-010 in Combination With Thalidomide and Dexamethasone for Relapsed/Refractory Multiple Myeloma

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 escalation phase and expansion phase ,Selinexor in Combination withThalidomide and Dexamethasone to Treat Relapsed/Refractory Multiple Myeloma Patients.To evaluate efficacy and safety of Selinexor in combination with Thalidomide 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 Ib/IIa study of Relapsed/Refractory Multiple Myeloma patients who have received at least one prior lines of treatment therapy; Approximately 3-48 patients will be enrolled in the study. In dose escalation phase, patients with RRMM will be treated with thalidomide 100mg/d, dexamethasone 20mg biweekly, and escalating doses of oral ATG-010 weekly in a 3+3 design. ATG-010 dose level (DL) 1, 2 and 3 are 60, 80 and 100mg respectively.

Then a phase 2 expansion at the recommended dose level based on phase 1b trial will be conducted to evaluate the efficacy, safety and tolerability.

This arm is 4 weeks per cycle and include a total of 12 cycles.Selinexor RP2D，Thalidomide will be given at 100mg/d d1-28, and Dexamethasone 20 mg/d will be given on day 1, 2,8,9,15,16,22,23. If a patient develops partial intolerance to glucocorticoids (as determined by the Investigator) during the study, a dose reduction of dexamethasone maximum to 10 mg is permitted. If patients do not tolerate this dose, a potential discontinuation or further dose reduction would be allowed.

Being tested
Selinexor, Thalidomide, Dexamethasone
Keywords
Selinexor, ATG-010, Multiple Myeloma, Relapsed/Refractory Multiple Myeloma, Thalidomide
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

    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.

  • ThalidomideDrug

    Also called fǎn yìng tíng

    100mg/d, Po. on day1-28

  • DexamethasoneDrug

    Also called Dex

    20 mg/d Po. on day 1, 2,8,9,15,16,22,23

Study groups in NCT04891744
Study groupRoleWhat they receive
Selinexor in combination with thalidomide and DexamethasoneExperimentalSelinexor in combination with thalidomide and Dexamethasone. Thalidomide will be given at 100mg/d d1-28,and Dexamethasone 20 mg/d will be given on day 1, 2,8,9,15,16,22,23. Treatment will be administered in 28-day cycles,include a total of 12 cycles. Selinexor dose escalation: 60, 80, 100mg respectively on day 1,8,15,22 for 4-week cycles. Then Selinexor will be given at the recommended dose level on phase II.
Receives: Drug: Selinexor; Drug: Thalidomide; 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. 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

  2. Disease Control Rate (DCR)

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

    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. Overall Survival (OS)

    The estimates of Kaplan-Meier

    Measured: 12 months

  5. Minimal Residual Disease (MRD)

    To evaluate the minimal residual disease in CR and sCR patients

    Measured: 12 months

  6. Clinical Benefit Rate (CBR)

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

    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 posted18 May 2021
  2. Study start6 Jul 2021 (estimated)
  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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
48 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04891744
Sponsor's protocol ID
ATG-010-IIT-MM-001
Status last verified
May 2021
First submitted
13 May 2021
Last updated
18 May 2021
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 1/2 study testing Selinexor, Thalidomide and Dexamethasone in people with Multiple Myeloma, run by Li Zheng 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 22 inclusion and 26 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 18 May 2021. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 Hongwei Li, MSc (18205191049, cpu_473lhw@126.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 NCT04891744.

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 18 May 2021.

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