Selinexor, Pomalidomide, and Dexamethasone For Multiple Myeloma With CNS Involvement (SPODUMENE)

January 30, 2024 updated by: Jin Lu, MD, Peking University People's Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

21

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Xuelin Dou, M.D.
  • Phone Number: 7003 +86-010-82816999
  • Email: dxldw@163.com

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100044
        • Recruiting
        • Peking University People's Hospital
        • Contact:
          • Xuelin Dou
          • Phone Number: 7003 +86-010-82816999
          • Email: dxldw@163.com
        • Principal Investigator:
          • Jin Lu
    • Shandong
      • Qingdao, Shandong, China
        • Recruiting
        • Qingdao Municipal Hospital
        • Contact:
        • Principal Investigator:
          • Yuping Zhong, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival
Time Frame: 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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 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
From date of enrollment until date of death from any cause, assessed up to 24 months.
Overall response rate
Time Frame: 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
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
Time Frame: 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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University People's Hospital

Collaborators

Qingdao Municipal Hospital

Investigators

  • Principal Investigator: Jin Lu, M.D., Peking University People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 12, 2022

Primary Completion (Estimated)

July 10, 2024

Study Completion (Estimated)

July 10, 2025

Study Registration Dates

First Submitted

July 24, 2022

First Submitted That Met QC Criteria

July 26, 2022

First Posted (Actual)

July 28, 2022

Study Record Updates

Last Update Posted (Estimated)

January 31, 2024

Last Update Submitted That Met QC Criteria

January 30, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01/20/2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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