Last updated: December 5, 2023
Sponsor: Chunyan Sun, MD
Overall Status: Active - Recruiting
Phase
2
Condition
Leukemia
Bone Diseases
Lymphoproliferative Disorders
Treatment
Cyclophosphamide
Selinexor (80mg/d)
Selinexor (100mg/d)
Clinical Study ID
NCT04877275
ATG-010-IIT-MM-002
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria: Patients must meet all of the following inclusion criteria to be eligible to enroll in thisstudy:
- 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) andachieved 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 exclusioncriteria) that relevant to previous therapies must have resolved to ≤Grade 2 prior tofirst dose of study drug.
- Left ventricular ejection fraction(LVEF )≥50% by an echocardiogram or MUGA scan in 42days before the first administration
- Adequate hepatic function: total bilirubin < 2× upper limit of normal (ULN) (forpatients 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 usingthe 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 toscreening 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 isconsidered of childbearing potential following menarche and until becomingpostmenopausal (defined as no menstrual period for a minimum of 12 months) orpermanently sterile (having undergone a hysterectomy, bilateral salpingectomy orbilateral oophorectomy). A woman who is taking oral contraceptive or usingintrauterine device is considered of childbearing potential.
- Male patients (including those who have received vasectomy) must use a condom ifsexually active with a female of child-bearing potential throughout the study and for 3 months following the last dose of study treatment.
Exclusion
Exclusion Criteria: 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.
- 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 withventricular tachycardia on antiarrhythmics are excluded; patients withfirst-degree atrioventricular (AV) block or asymptomatic left anterior fascicularblock/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 ofstudy 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 (exceptfor skin basal-cell carcinoma and in-situ carcinoma including squamous cell carcinoma,bladder cancer in situ, endometrial cancer in situ, cervical cancer in situ/atypicalhyperplasia, prostate cancer incidental finding (T1a or T1b), or breast cancer insitu) within 5 years prior to the first dose of study drug.
- Active GI dysfunction interfering with the ability to swallow tablets, or any GIdysfunction that could interfere with absorption of study treatment.
- Grade ≥ 3 peripheral neuropathy, and Grade ≥ 2 painful neuropathy, within 3 weeksprior to the first dose of study drug.
- Serious, active psychiatric, or medical conditions which, in the opinion of theInvestigator, could interfere with study treatment.
- Participation in an investigational anti-cancer clinical study within 3 weeks or 5half-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 previousallogeneic stem cell transplantation (no time limitation).
- Treatment with an approved or trial anticancer drug was given within 3 weeks or 5half-lives (T1/2) (With a short time priority) prior to the first study.
- Prior exposure to a SINE compound.
Study Design
Total Participants: 50
Treatment Group(s): 5
Primary Treatment: Cyclophosphamide
Phase: 2
Study Start date:
May 21, 2021
Estimated Completion Date:
December 30, 2024
Study Description
Connect with a study center
Henan Cancer Hospital
Zhengzhou, Henan 450000
ChinaActive - Recruiting
Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei 430022
ChinaActive - Recruiting
Zhongnan Hospital of Wuhan University
Wuhan, Hubei 430071
ChinaSite Not Available
The First Affiliated Hospital of Air Force Medical University
Xi'an, Shanxi 710000
ChinaSite Not Available
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shanxi 710004
ChinaSite Not Available

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