NCT05597345 · University of Rochester
Selinexor for the Treatment of Intermediate and High-Risk Smoldering Multiple Myeloma
What this study is about
Selinexor is a drug that has been approved in the treatment of patients with symptomatic multiple myeloma. The the usual treatment 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.
View original scientific 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Rochester, New York
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 10, 2025 · Source of record for eligibility and locations