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

NCT05478993 | Unknown Phase 2

• 1 other identifier: 01/20/2022
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 2

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.

Conditions

Multiple Myeloma

Keywords

Central Nervous System

Outcome Measures

Primary Outcomes (1)

• Progression free survival

  Assessed using the updated International Myeloma Working Group Response Criteria

  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.

Secondary Outcomes (3)

• Overall survival

  From date of enrollment until date of death from any cause, assessed up to 24 months.

• 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.

• 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.

Study Arms (1)

Selinexor, pomalidomide and dexamethasone

EXPERIMENTAL

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

Drug: SPD：Selinexor Oral Tablet, Pomalidomide, Dexamethasone

Interventions

SPD：Selinexor Oral Tablet, Pomalidomide, Dexamethasone DRUG

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.

Selinexor, pomalidomide and dexamethasone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years.
• Patients with multiple myeloma with measurable lesions as assessed using the updated International Myeloma Working Group Response Criteria.
• 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.
• ECOG ≤ 2, with expected survival of more than 3 months.
• No active infectious diseases.
• Major organs without serious organic diseases (except renal insufficiency caused by multiple myeloma).
• 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.
• 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.
• 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.

You may not qualify if:

• Patients with active hepatitis B (HBV), hepatitis C (HCV), and other acquired, congenital immunodeficiency diseases;
• 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;
• Severe thrombotic events before treatment;
• 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;
• Major surgery within 30 days before enrollment;
• Epilepsy and dementia which requires drug treatment, and other mental disorders which cannot understand or follow the study protocol;
• According to the protocol or the investigator 's judgment, any severe physical illness or mental illness may interfere with participation in this clinical study;
• Drug abuse, medical, psychological or social conditions that may interfere with the participation of subjects in the study or evaluation of study results;
• Patients who are receiving other experimental treatment;
• Pregnant or lactating women;
• Not suitable for enrollment per investigators' judgements.

Sponsors & Collaborators

• Peking University People's Hospital: lead
• Qingdao Municipal Hospital: collaborator

Study Sites (2)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

RECRUITING

Qingdao Municipal Hospital

Qingdao, Shandong, China

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

Interventions

pomalidomide; Dexamethasone

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Jin Lu, M.D.

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xuelin Dou, M.D.

CONTACT

+86-010-82816999; dxldw@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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 Record Dates

• First Submitted: July 24, 2022
• First Posted: July 28, 2022
• Study Start: October 12, 2022
• Primary Completion: July 10, 2024
• Study Completion: July 10, 2025
• Last Updated: January 31, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)