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Selinexor for Intermediate and High-Risk Smoldering Multiple Myeloma

This study is looking at a drug called Selinexor for people with intermediate or high-risk smoldering multiple myeloma (SMM). SMM is a condition that can sometimes turn into multiple myeloma, a type of cancer. Selinexor is already approved for treating multiple myeloma. Currently, people with SMM are usually just watched closely, but this study wants to see if low-dose Selinexor can help delay SMM from progressing to multiple myeloma. You can join if you are 18 or older and have been diagnosed with SMM that doesn't yet show signs of active multiple myeloma (like high calcium, anemia, bone damage, or kidney problems). The main goal is to see how many people progress to multiple myeloma within two years after finishing treatment. The study plans to enroll 15 participants, but its current status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 15 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for two years after the end of treatment to see if their smoldering multiple myeloma progresses.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05597345

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
University of Rochester
~15 participants
Updated 2025-02-10 on ClinicalTrials.gov
What's tested:Selinexor

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Rate of progression to Multiple Myeloma
Measured over 2 years after end of treament

Conditions

Smoldering Multiple Myeloma

Explore related trials

Smoldering Multiple Myeloma

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Jodi Lipof · PRINCIPAL_INVESTIGATOR · University of Rochester

Who to contact

Jodi Lipof
[email protected]
6505042400
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Rate of progression to Multiple Myeloma2 years after end of treament

    The study will assess how long participants will not have the cancer get worse while treated with selinexor