Selinexor in Combination With Immunomodulator 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 location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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. This is a single-arm that includes three arms, Selinexor(ATG-010) in Combination with Immunomodulator (Thalidomide/ Pomalidomide/ Lenalidomide)and Dexamethasone to Treat Relapsed/Refractory Multiple Myeloma Patients. To evaluate efficacy and safety of Selinexor in combination with Immunomodulator and Dexamethasone 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
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• 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) ≥ 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.

Locations
Other Locations
China
Shanghai Changzheng Hospital
RECRUITING
Shanghai
Contact Information
Primary
Juan Du, M.D., Ph.D
Changzheng_pg@163.com
15800706091
Backup
Hongwei Li, MSc
cpu_473lhw@126.com
18205191049
Time Frame
Start Date: 2022-01-27
Estimated Completion Date: 2025-12-30
Participants
Target number of participants: 90
Treatments
Experimental: Arm I: Selinexor+Thalidomide+Dexamethasone
Arm I is given XTd regimen Selinexor 60mg/d QW, Thalidomide 100mg/d, d1-28 and Dexamethasone 40mg/d QW) in approximately 30 subjects. 4 weeks per cycle and include a total of 12 cycles.
Experimental: Arm II: Selinexor+Lenalidomide+Dexamethasone
Arm II is given XRd regimen Selinexor 60mg/d QW, Lenalidomide 25mg/d, d1-21 and Dexamethasone 40mg/d QW) in approximately 30 subjects. 4 weeks per cycle and include a total of 12 cycles.
Experimental: Arm III: Selinexor+Pomalidomide+Dexamethasone
Arm III is given XPd regimen Selinexor 60mg/d QW, Pomalidomide 4mg/d, d1-21 and Dexamethasone 40mg/d QW) in approximately 30 subjects. 4 weeks per cycle and include a total of 12 cycles.
Related Therapeutic Areas
Sponsors
Leads: Juan Du

This content was sourced from clinicaltrials.gov

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