Treatment for multiple myeloma with central nervous system involvement

A Phase 2 Study of Selinexor, Pomalidomide, and Dexamethasone For Multiple Myeloma With Central Nervous System Involvement

This study is testing a new combination treatment for people with multiple myeloma that has spread to the brain and spinal cord to see if it helps them feel better.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 21 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Peking University People's Hospital (Academic / other)
• Locations: 2 sites (Beijing, Beijing and 1 other locations)
• Trial ID: NCT05478993 on ClinicalTrials.gov

What this trial studies

This exploratory study evaluates the efficacy and safety of a combination treatment using Selinexor, pomalidomide, and dexamethasone in patients diagnosed with multiple myeloma that has spread to the central nervous system. It is a single-arm, open-label, multicenter study where participants will receive the treatment regimen over multiple cycles. The study aims to determine the maximum efficacy of the treatment and will transition to maintenance therapy if patients respond positively after 8-12 cycles.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with multiple myeloma and measurable CNS lesions.

Not a fit: Patients with active infectious diseases or serious organic diseases unrelated to multiple myeloma may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with multiple myeloma that has CNS involvement.

How similar studies have performed: While there have been studies on multiple myeloma treatments, this specific combination approach targeting CNS involvement is novel and has not been extensively tested.

Eligibility 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.

Where this trial is running

Beijing, Beijing and 1 other locations

• Peking University People's Hospital — Beijing, Beijing, China (Recruiting)
• Qingdao Municipal Hospital — Qingdao, Shandong, China (Recruiting)

Study contacts

• Principal investigator: Jin Lu, M.D. — Peking University People's Hospital
• Study coordinator: Xuelin Dou, M.D.

Conditions Multiple Myeloma; Central Nervous System