SPODUMENE: Selinexor, Pomalidomide, and Dexamethasone For Multiple Myeloma With CNS Involvement
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
This is a single-arm, open-label, multicenter, exploratory study. The study plans to enroll patients diagnosed with multiple myeloma with CNS involvement to receive Selinexor (60 mg QW), pomalidomide (4 mg/day, on Days 1-21), and dexamethasone (40 mg/day, on Days 1, 8, 15, 22), with all agents dosed 28 days per cycle.
If patients reach maximum efficacy and have received SPD treatment for 8-12 cycles, maintenance treatment of Selinexor (20-60mg QW, optimal dose determined by the investigator) will be started and continued until disease progression or intolerable adverse events.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Selinexor, pomalidomide and dexamethasone Patients diagnosed with multiple myeloma with CNS involvement to receive SPD treatment. |
Drug: SPD：Selinexor Oral Tablet, Pomalidomide, Dexamethasone
Patients diagnosed with multiple myeloma with CNS involvement to receive Selinexor (60 mg QW), pomalidomide (4 mg/day, on Days 1-21), and dexamethasone (40 mg/day, on Days 1, 8, 15, 22), with all agents dosed 28 days per cycle.
If patients reach maximum efficacy and have received SPD treatment for 8-12 cycles, maintenance treatment of Selinexor (20-60mg QW, optimal dose determined by the investigator) will be started and continued until disease progression or intolerable adverse events.
|
Outcome Measures
Primary Outcome Measures
- Progression free survival [From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.]
Assessed using the updated International Myeloma Working Group Response Criteria
Secondary Outcome Measures
- Overall survival [From date of enrollment until date of death from any cause, assessed up to 24 months.]
Assessed using the updated International Myeloma Working Group Response Criteria
- Overall response rate [From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.]
Assessed using the updated International Myeloma Working Group Response Criteria
- Adverse Events [From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.]
Assessed using the CTCAE criteria.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age ≥ 18 years.
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Patients with multiple myeloma with measurable lesions as assessed using the updated International Myeloma Working Group Response Criteria.
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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.
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ECOG ≤ 2, with expected survival of more than 3 months.
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No active infectious diseases.
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Major organs without serious organic diseases (except renal insufficiency caused by multiple myeloma).
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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.
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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.
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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:
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Patients with active hepatitis B (HBV), hepatitis C (HCV), and other acquired, congenital immunodeficiency diseases;
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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;
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Severe thrombotic events before treatment;
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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;
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Major surgery within 30 days before enrollment;
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Epilepsy and dementia which requires drug treatment, and other mental disorders which cannot understand or follow the study protocol;
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According to the protocol or the investigator 's judgment, any severe physical illness or mental illness may interfere with participation in this clinical study;
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Drug abuse, medical, psychological or social conditions that may interfere with the participation of subjects in the study or evaluation of study results;
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Patients who are receiving other experimental treatment;
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Pregnant or lactating women;
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Not suitable for enrollment per investigators' judgements.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Peking University People's Hospital | Beijing | Beijing | China | 100044 |
| 2 | Qingdao Municipal Hospital | Qingdao | Shandong | China |
Sponsors and Collaborators
- Peking University People's Hospital
- Qingdao Municipal Hospital
Investigators
- Principal Investigator: Jin Lu, M.D., Peking University People's Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2022LinShenZiYDi004Hao