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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05478993
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Peking University People's Hospital
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Jin Lu, M.D.
Principal Investigator Affiliation Peking University People's Hospital
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Multiple Myeloma
Additional Details

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.

Arms & Interventions

Arms

Experimental: Selinexor, pomalidomide and dexamethasone

Patients diagnosed with multiple myeloma with CNS involvement to receive SPD treatment.

Interventions

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.

Contact a Trial Team

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International Sites

Peking University People's Hospital, Beijing, Beijing, China

Status

Recruiting

Address

Peking University People's Hospital

Beijing, Beijing, 100044

Site Contact

Xuelin Dou

[email protected]

+86-010-82816999 #7003

Qingdao Municipal Hospital, Qingdao, Shandong, China

Status

Recruiting

Address

Qingdao Municipal Hospital

Qingdao, Shandong,

Site Contact

Xudong Dai

[email protected]

+86-0532-82789053

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