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

Who is this study for? Patients with Multiple Myeloma
What treatments are being studied? Selinexor+Dexamethasone
Status: Recruiting
Location: See all (5) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

• 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.

Locations
Other Locations
China
Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
RECRUITING
Wuhan
Zhongnan Hospital of Wuhan University
NOT_YET_RECRUITING
Wuhan
The First Affiliated Hospital of Air Force Medical University
NOT_YET_RECRUITING
Xi’an
The Second Affiliated Hospital of Xi'an Jiaotong University
NOT_YET_RECRUITING
Xi’an
Henan Cancer Hospital
RECRUITING
Zhengzhou
Contact Information
Primary
Chunyan Sun, M.D., Ph.D
suncy0618@163.com
13237183940
Backup
Hongwei Li, MSc
cpu_473lhw@126.com
18205191049
Time Frame
Start Date: 2021-05-21
Estimated Completion Date: 2024-12-30
Participants
Target number of participants: 50
Treatments
Experimental: 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.
Experimental: 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.
Related Therapeutic Areas
Sponsors
Leads: Chunyan Sun, MD

This content was sourced from clinicaltrials.gov

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