RECRUITING

Selinexor for the Treatment of Intermediate and High-Risk Smoldering Multiple Myeloma

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Selinexor is a drug that has been approved in the treatment of patients with symptomatic multiple myeloma. The standard of care for patients with Smoldering Multiple Myeloma remains observation, but there are numerous clinical trials investigating interventions to delay progression to multiple myeloma and prevent or delay disease related outcomes. A subset of patients with intermediate or high risk smoldering multiple myeloma have a much higher risk of progressive to multiple myeloma, while the low risk smoldering myeloma patient population has a much lower risk. This is a clinical trial investigating the use of low-dose selinexor in patients with intermediate to high-risk smoldering multiple myeloma. The investigators hypothesize that the use of selinexor in intermediate to high risk smoldering myeloma patients will help to delay progression of disease to symptomatic multiple myeloma.

Official Title

Selinexor for the Treatment of Patients With Intermediate and High-Risk Smoldering Multiple Myeloma

Quick Facts

Study Start:2023-08-21
Study Completion:2024-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05597345

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age \>/= 18 years
  2. * Histologically confirmed diagnosis of SMM according to the IMWG definition: serum M-protein \>/= 3 g/dL or BMPC \>10% but \<60%, or both.
  3. * Should not meet CRAB criteria: hypercalcemia, anemia, bone lesions, or renal insufficiency thought to be related to the plasma cell disorder.
  4. * Should have 1 of the following risk factors to be considered intermediate risk and 2 or more risk factors to be considered high-risk:
  5. * BMPC\>/=20%
  6. * M-spike \>/= 2g/dL
  7. * Involved to uninvolved sFLC ratio of \>/= 20
  8. * normal hepatic function within 28 days prior to C1D1
  9. * Adequate renal function within 28 days prior to C1D1. Estimated creatinine clearance (CrCl) calculated using formula of Cockcroft and Gault. CrCl \>/= 15 mL/min.
  10. * Adequate hematopoietic function within 28 days prior to C1D1: absolute neutrophil count (ANC)\>/=1.5 x10\^9/L, hemoglobin \>/=10g/dL, platelets \>/150x10\^9/L.
  11. * Life expectancy of \>12 months.
  12. * ECOG PS 0-1
  13. * Subjects with reproductive potential must use 2 highly effective methods of effective contraception or practice sexual abstinence throughout the study and continue for 6 months after the study has closed. Subjects who are surgically sterile (e.g., history of bilateral tubal ligation, hysterectomy, or whos partner is sterile are not required to use additional modes of contraception.
  14. * Ability to understand and willingness
  1. * Meets criteria for symptomatic MM as defined by any of the following, determined to be related to the plasma cell disorder
  2. * Hypercalcemia (corrected serum calcium \>11.0 mg/dL)
  3. * Renal insufficiency (creatinine \>2.0 mg/dL)
  4. * Anemia (hemoglobin \<10g/dL)
  5. * One or more osteolytic bone lesions on radiography, but more than one lesion required if \<10% clonal bone marrow plasma cells. Based on MRI imaging, there must be more than one lesion \>5mm in size.
  6. * Clonal bone marrow plasma cells ≥60%
  7. * An involved serum free light chain ≥ 100mg/L with the ratio of the involved/uninvolved free light chains also ≥100
  8. * Documented systemic light chain amyloidosis
  9. * Systemic corticosteroids \>10mg prednisone (or equivalent) daily for other medical conditions.
  10. * Active invasive malignancy within the past 3 years that may affect the results or interfere with the interpretation of results of this study.
  11. * Non-invasive malignancy that was not treated with curative intent within the past 3 years that may affect the results or interfere with the interpretation of the results of this study.
  12. * Uncontrolled active infection requiring parenteral antibiotics, antivirals, or antifungals within 14 days of the receiving the first dose
  13. * Known active HIV infection without adequate anti-retroviral therapy
  14. * Active gastrointestinal dysfunction that prevents patient from swallowing tablets or may interfere with absorption of study treatment
  15. * Pregnant, breast feeding, or planning to become pregnant within 6 months after the end of treatment.
  16. * Subject of reproductive potential that is not willing to use two methods of highly effective contraception during treatment period and for 6 months after the end of treatment.
  17. * Any major medical or psychiatric disorder that, in the opinion of the investigator, might prevent the subject from completing the study or interfere with the interpretation of the study results.
  18. * Prior exposure to a SINE compound, including Selinexor.

Contacts and Locations

Study Contact

Jodi Lipof
CONTACT
6505042400
jodi_lipof@urmc.rochester.edu
Brea Lipe
CONTACT
Brea_Lipe@urmc.rochester.edu

Principal Investigator

Jodi Lipof
PRINCIPAL_INVESTIGATOR
University of Rochester

Study Locations (Sites)

University of Rochester
Rochester, New York, 14642
United States

Collaborators and Investigators

Sponsor: University of Rochester

  • Jodi Lipof, PRINCIPAL_INVESTIGATOR, University of Rochester

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 Registration Dates

Study Start Date2023-08-21
Study Completion Date2024-12-31

Study Record Updates

Study Start Date2023-08-21
Study Completion Date2024-12-31

Terms related to this study

Keywords Provided by Researchers

  • Smoldering Multiple Myeloma
  • Smoldering Myeloma
  • Multiple Myeloma
  • Myeloma
  • MGUS

Additional Relevant MeSH Terms

  • Smoldering Multiple Myeloma