A Prospective Sponsor-investigator Clinical Study for dose-finding of selinexor in Relapsed and/or Refractory Multiple Myeloma (RRMM) Patients with Impaired Renal Functio

Not Applicable

• Conditions: Neoplasms

• Registration Number: KCT0008434
• Lead Sponsor: The Catholic University of Korea, Seoul St. Mary's Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 30 May 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

1) Men or women 19 years of age or older
2) Relapsed in accordance with IMWG standards (19. Other matters necessary for safe and scientific conduct of clinical research) or refractory multiple myeloma patients
3) Patients with multiple myeloma diagnosis who satisfy the following (all of the following)
- Monoclonal plasma cells in the bone marrow %10% or plasma cell species identified by biopsy
- Patients with multiple myeloma that can be evaluated and who fall under one or more of the following
i. Serum M-protein 0 0.5 g/dL or urine M-protein 200 200 mg/24 hours
ii. IgA multiple myeloma: serum M-protein 00.5 g/dL or urine M-protein 200200 mg/24 hours
iii. Hard-chain multiple myeloma: Serum glass hard-chain (sFLC) 100100 mg/L and abnormal serum kappa/lambda free hard-chain ratio
4) Proteasome inhibitor, immunomodulatory drug, and CD38
Patients who have failed at least three systemic treatments, including CD38 targeted monoclonal antibody.
5) Patients who have not previously been treated at Cellinex
6) Accompanying renal dysfunction: glomerular filtration rate predicted by MDRD formula <20 mL/min
7) Proper liver function (satisfied with all of the following)
- Serum total bilirubin is less than twice the normal upper limit (however, if you have Gilbert syndrome)
less than 3x)
- AST/ALT less than 2.5 times the normal upper limit
8) (Eastern Cooperative Oncology Group Performance Status) 0-2
9) Normal cardiac function (Ejection fracture 45 45%)
10) Proper bone marrow function (satisfying all of the following)
- Neutral sphere 800/ul or higher
- Platelet count above 30,000/ul
- - Hemoglobin 7 g/dL
11) If the subject is a woman,
- If the amenorrhea period is at least 1 year (female after menopause),
- Before the start of treatment (at the time of screening), the urine pregnancy test is negative and can maintain contraception during the study period.
a woman
[Limited to women before menopause or women with menopause within 1 year (within 1 year since menopause)]
*During the consent process for women of childbearing age, contraception methods such as natural cycle and abstinence are used according to the Catholic ideology of the present application.
Guide the subject.

Exclusion Criteria

1) Asymptomatic multiple myeloma, active plasma cell
Selinexor Exploratory PK in MM Patients with Renal Impairment Ver.1.0 / 2022.11.14
4/13
leukemia), undetermined monoclonal gamma globulinemia (MGUS), or multiple myeloma invading the central nervous system.
2) cardiovascular dysfunction of activity
3) HIV positive
4) Active hepatitis A, B or C
5) Accompanying cancer diseases that are currently being treated or that require treatment
6) Except for non-melanoma skin cancer and intraepithelial cervical cancer, which has been completely cured within the last five years, a patient with a history of other cancers
7) Peripheral neuropathy of severity 3 or higher or neuroinflammatory with pain of severity 2 or higher
8) Participating in a clinical study in which another anti-tumor drug is administered within 3 weeks
9) Platelet transfusion or red blood cell transfusion is performed within 2 days of the first day of the first cycle.
10) If the following hematopoietic promoter is administered within two days of the first day of the first cycle:
(G-CSF, GM-CSF, erythropoietin, megakaryocyte growth factor)
11) When a SINE compound was previously administered, including Selinexor
12) Accompanying mental illness that is difficult to participate in this study
13) Pregnant women

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression - free survival

Secondary Outcome Measures

Name	Time	Method
Overall survival;Overall response rate; Rates of very good partial response or better;Toxicity and side effects during progression-free survival;Secondary progression-free survival;Overall response rate according to secondary treatment in patients who received secondary treatment