Selinexor, Pomalidomide, and Dexamethasone For Multiple Myeloma With CNS Involvement

• Status: Recruiting
• Trial end date: 2024-07-10
• Target enrollment: 0
• Participant gender: All

Summary

This is a single-arm, open-label, multicenter, exploratory study initiated by investigator to evaluate the efficacy and safety of Selinexor (S) combined with pomalidomide (P) and dexamethasone (D) in the treatment of multiple myeloma with CNS involvement.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking University People's Hospital
• Collaborator: Qingdao Municipal Hospital
• Treatments: Dexamethasone; Pomalidomide

Criteria

Inclusion Criteria:

1. Age ≥ 18 years.

2. Patients with multiple myeloma with measurable lesions as assessed using the updated International Myeloma Working Group Response Criteria.

3. Multiple myeloma patients with central nervous system involvement (CNS-MM): the presence of plasma cells in the cerebrospinal fluid (CSF), and/or leptomeningeal, dural, or intraparenchymal involvement as assessed using imaging modalities (MRI, CT or PET-CT), and/or tissue biopsy; or eye involvement confirmed by ophthalmologists, with or without neurological symptoms.

4. ECOG ≤ 2, with expected survival of more than 3 months.

5. No active infectious diseases.

6. Major organs without serious organic diseases (except renal insufficiency caused by multiple myeloma).

7. Female patients are not during pregnancy or breastfeeding; fertile men or women agree to use appropriate methods of contraception 4 weeks before study treatment, during treatment and drug suspension, and within 4 weeks after the end of study treatment.

8. Be able to cooperate with study follow-up. Patients understand the disease characteristics and voluntarily join this study to receive treatments and study follow-ups.

9. Have signed informed consent. Informed consent was signed by the patient or by an immediate family member. Considering the patient 's condition, if the patient' s signature is unfavorable for disease treatment, the informed consent form should be signed by the legal guardian or the patient 's immediate family member.

Exclusion Criteria:

1. Patients with active hepatitis B (HBV), hepatitis C (HCV), and other acquired, congenital immunodeficiency diseases;

2. According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) 5.0, baseline with grade 2 or higher peripheral neuropathy or neuralgia;

3. Severe thrombotic events before treatment;

4. Patients with uncontrolled or severe cardiovascular disease, including myocardial infarction within 6 months before enrollment, New York Heart Association (NYHA) defined grade III-IV heart failure, uncontrolled angina pectoris, clinically significant pericardial disease or cardiac amyloidosis;

5. Major surgery within 30 days before enrollment;

6. Epilepsy and dementia which requires drug treatment, and other mental disorders which cannot understand or follow the study protocol;

7. According to the protocol or the investigator 's judgment, any severe physical illness or mental illness may interfere with participation in this clinical study;

8. Drug abuse, medical, psychological or social conditions that may interfere with the participation of subjects in the study or evaluation of study results;

9. Patients who are receiving other experimental treatment;

10. Pregnant or lactating women;

11. Not suitable for enrollment per investigators' judgements.