ATG-010(Selinexor) in Combination With Chemotherapy in RRMM
NCT ID: NCT04877275
Last Updated: 2023-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
50 participants
INTERVENTIONAL
2021-05-21
2024-12-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm I: Selinexor+Pegylated liposomal doxorubicin +Dexamethasone
Arm 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.
Selinexor (80mg/d)
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 ;
Pegylated liposomal doxorubicin
25 mg/m\^2 intravenously on day 1 , QW
Dexamethasone
Dexamethasone 40mg/d QW
Arm II: Selinexor+Cyclophosphamide+Dexamethasone
Arm 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.
Selinexor (100mg/d)
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 ;
Dexamethasone
Dexamethasone 40mg/d QW
Cyclophosphamide
Cyclophosphamide：300mg/m2, d1 QW，
Interventions
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Selinexor (80mg/d)
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)
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 doxorubicin
25 mg/m\^2 intravenously on day 1 , QW
Dexamethasone
Dexamethasone 40mg/d QW
Cyclophosphamide
Cyclophosphamide：300mg/m2, d1 QW，
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Age ≥ 18 years and ≤ 75 years.
3. 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.
4. At or after accepting first-line regimen, subjects must have progression disease (PD) recorded which is determined by researcher according to IMWG criteria.
Exclusion Criteria
7. 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.
8. Adequate renal function: estimated creatinine clearance ≥ 20 mL/min (calculated using the formula of Cockroft-Gault).
9. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2.
10. Measurable MM as defined by at least one of the following:
1. Serum M-protein (SPEP) ≥ 5 g/L
2. 24 hours-Urinary M-protein excretion ≥ 0.2 g (200 mg)
3. Serum FLC ≥ 100 mg/L with abnormal FLC ratio
11. Expected survival is more than 6 months.
12. Adequate hematopoietic function (no platelet transfusion within 2 weeks prior to screening test):
1. Hemoglobin level ≥ 60 g/L
2. ANC ≥ 1,000/mm3 (1.0×109/L)
3. Platelet count ≥ 75,000/mm3 (75×109/L)
13. Female patients of childbearing potential must meet below two criteria:
1. 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.
2. 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.
14. 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.
Patients who meet any of the following criteria will not be enrolled:
1. Asymptomatic (smoldering) MM.
2. Plasma cell leukemia.
3. Documented active amyloidosis.
4. Previously refractory or intolerant to combined drugs.
5. Pregnancy or breastfeeding.
6. Major surgery was performed within 4 weeks prior to the first study.
7. Patients with active, unstable cardiovascular diseases, fits any of the following:
1. Symptomatic ischemia, or
2. 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
3. Congestive heart failure (CHF) of New York Heart Association (NYHA) ≥ Grade 3, or
4. Acute myocardial infarction (AMI) within 3 months prior to the first dose of study drug.
8. Uncontrolled active infection within 1 week prior to the first dose of study drug.
9. Known HIV positive.
10. 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)
11. 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.
12. Active GI dysfunction interfering with the ability to swallow tablets, or any GI dysfunction that could interfere with absorption of study treatment.
13. Grade ≥ 3 peripheral neuropathy, and Grade ≥ 2 painful neuropathy, within 3 weeks prior to the first dose of study drug.
14. Serious, active psychiatric, or medical conditions which, in the opinion of the Investigator, could interfere with study treatment.
15. 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.
16. Received ASCT within 12 weeks prior to the first dose of study drug or previous allogeneic stem cell transplantation (no time limitation).
17. 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.
18. Prior exposure to a SINE compound.
18 Years
75 Years
ALL
No
Sponsors
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Chunyan Sun, MD
OTHER
Responsible Party
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Chunyan Sun, MD
Chief physician, professor
Principal Investigators
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Chunyan Sun, M.D., Ph.D
Role: PRINCIPAL_INVESTIGATOR
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Locations
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Henan Cancer Hospital
Zhengzhou, Henan, China
Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China
The First Affiliated Hospital of Air Force Medical University
Xi’an, Shanxi, China
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, China
Countries
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Central Contacts
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Facility Contacts
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Baijun Fang, Ph.D
Role: primary
Chunyan Sun, M.D.,Ph.d
Role: primary
Fuling Zhou, Ph.D
Role: primary
Guangxun Gao, PhD
Role: primary
Aili He, Ph.D
Role: primary
Other Identifiers
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ATG-010-IIT-MM-002
Identifier Type: -
Identifier Source: org_study_id