Recruiting
Phase 2

Selinexor

Sponsor:

University of Rochester

Code:

NCT05597345

Conditions

Smoldering Multiple Myeloma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Selinexor

Study Details

Brief summary:

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.

Conditions

Smoldering Multiple Myeloma

Study ID

NCT05597345

Start date

Aug 21, 2023

Status verified date

Feb, 2025

Completion date

Dec 31, 2025

Anticipated

Primary completion date

Oct 29, 2024

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age >/= 18 years
  • Histologically confirmed diagnosis of SMM according to the IMWG definition: serum M-protein >/= 3 g/dL or BMPC >10% but <60%, or both.
  • Should not meet CRAB criteria: hypercalcemia, anemia, bone lesions, or renal insufficiency thought to be related to the plasma cell disorder.
  • Should have 1 of the following risk factors to be considered intermediate risk and 2 or more risk factors to be considered high-risk:
  • BMPC>/=20%
  • M-spike >/= 2g/dL
  • Involved to uninvolved sFLC ratio of >/= 20
  • normal hepatic function within 28 days prior to C1D1
  • Adequate renal function within 28 days prior to C1D1. Estimated creatinine clearance (CrCl) calculated using formula of Cockcroft and Gault. CrCl >/= 15 mL/min.
  • 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.
  • Life expectancy of >12 months.
  • ECOG PS 0-1
  • 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.
  • Ability to understand and willingness

Exclusion Criteria:

  • Meets criteria for symptomatic MM as defined by any of the following, determined to be related to the plasma cell disorder

  • Hypercalcemia (corrected serum calcium >11.0 mg/dL)
  • Renal insufficiency (creatinine >2.0 mg/dL)
  • Anemia (hemoglobin <10g/dL)
  • 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.
  • Clonal bone marrow plasma cells ≥60%
  • An involved serum free light chain ≥ 100mg/L with the ratio of the involved/uninvolved free light chains also ≥100
  • Documented systemic light chain amyloidosis
  • Systemic corticosteroids >10mg prednisone (or equivalent) daily for other medical conditions.
  • Active invasive malignancy within the past 3 years that may affect the results or interfere with the interpretation of results of this study.
  • 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.
  • Uncontrolled active infection requiring parenteral antibiotics, antivirals, or antifungals within 14 days of the receiving the first dose
  • Known active HIV infection without adequate anti-retroviral therapy
  • Active gastrointestinal dysfunction that prevents patient from swallowing tablets or may interfere with absorption of study treatment
  • Pregnant, breast feeding, or planning to become pregnant within 6 months after the end of treatment.
  • 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.
  • 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.
  • Prior exposure to a SINE compound, including Selinexor.

Study Design

Enrollment

15 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Experimental: Treatment

Selinexor 40mg weekly for up to 12 cycles. Each cycle will be 28 days in length.

Interventions

Selinexor

Low-dose Selinexor for the Treatment of Intermediate to High-Risk Smoldering Multiple Myeloma

Primary outcome measure

  • Rate of progression to Multiple Myeloma [ Time Frame: 2 years after end of treament ]

Central Contacts and Locations

Central contacts

Jodi Lipof

6505042400jodi_lipof@urmc.rochester.edu

Brea Lipe

Brea_Lipe@urmc.rochester.edu

Locations

University of Rochester

Recruiting

Rochester, New York, United States, 14642

Contacts

Jodi Lipof

jodi_lipof@urmc.rochester.edu

More Information

Sponsor

University of Rochester

Last update posted

Feb 10, 2025

Last verified

Feb, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Rochester on 2025-02-10.