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New treatment option for Multiple Myeloma in Relapse
Official title A Trial of Selinexor, Ruxolitinib and Methylprednisolone
ClinicalTrials.gov ID: NCT06225310
What this study is testing
What is Selinexor?
Selinexor is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for multiple myeloma in relapse.
Also referred to as XPOVIO.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Selinexor, a first-in-class, oral selective exportin 1 (XPO1) inhibitor, has shown promise in pre-clinical and clinical studies. It functions by inhibiting the nuclear export protein XPO1, resulting in the accumulation of tumor suppressor proteins and inhibition of oncoprotein mRNAs, which is selectively lethal to myeloma cells.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults
You may be able to join if
- Patients must meet all the following to be eligible to enroll in this study: 1\. Has a diagnosis of MM based on standard criteria as follows: Myeloma...
- Evidence of end organ damage that can be attributed to the underlying plasma cell proliferative disorder, specifically
- Hypercalcemia: serum calcium \>0.25 mmol/L (\>1mg/dL) higher than the upper limit of normal or \>2.75 mmol/L (\>11mg/dL)
- Renal insufficiency: creatinine clearance \ 177mol/L (\>2mg/dL)
- Anemia: hemoglobin value of \>20g/L below the lowest limit of normal, or a hemoglobin value \<100g/L
You likely can't join if
- Patients meeting any of the following exclusion criteria are not eligible to enroll in this study:
- Patients who had prior exposure to ruxolitinib or selinexor
- Prior malignancy that required treatment or has shown evidence of recurrence (except for non-melanoma skin cancer or adequately treated cervical...
- Have light chain amyloidosis
- Have plasma cell leukemia
- Have history of active tuberculosis
See the full eligibility criteria
Who can join
- Patients must meet all the following to be eligible to enroll in this study: 1\. Has a diagnosis of MM based on standard criteria as follows: Myeloma criteria: Must be At least 1 of 2 1. Clonal bone marrow plasma cells...
- Evidence of end organ damage that can be attributed to the underlying plasma cell proliferative disorder, specifically
- Hypercalcemia: serum calcium \>0.25 mmol/L (\>1mg/dL) higher than the upper limit of normal or \>2.75 mmol/L (\>11mg/dL)
- Renal insufficiency: creatinine clearance \ 177mol/L (\>2mg/dL)
- Anemia: hemoglobin value of \>20g/L below the lowest limit of normal, or a hemoglobin value \<100g/L
- Bone lesions: one or more osteolytic lesion on skeletal radiography, CT, or PET/CT. If bone marrow has \<10% clonal plasma cells, more than one bone lesion is required to distinguish from solitary plasmacytoma with...
- 60% or greater clonal plasma cells on bone marrow examination
- Serum involved / uninvolved free light chain ratio of 100 or greater, provided the absolute level of the involved light chain is at least 100 mg/L (a patient's involved free light chain either kappa or lambda is the one...
- More than one focal lesion on MRI that is at least 5mm or greater in size The patient must have met the criteria for Active Myeloma at some stage following the diagnosis of Myeloma. Source documentation for both Myeloma...
- Anti-CD38 antibody
- Immunomodulatory agent (IMiD)
- Proteasome inhibitor (PI) 4. Currently has MM with measurable disease, defined as:
- a monoclonal immunoglobulin spike on serum electrophoresis of at least 0.5 g/dL and/or urine monoclonal protein levels of at least 200 mg/24 hours
- for patients without measurable serum and urine M-protein levels, an involved SFLC \> 100 mg/L or abnormal SFLC ratio
- for patients with IgD MM, a monoclonal immunoglobulin IgD of at least 5500 mg/L or meet other measurable disease eligibility criteria
- for patients with IgA MM, total IgA of \> 700 mg/dL 5. Currently has progressive MM: MM patients that are relapsed or have refractory disease from at least 3 regimens or lines of therapy are eligible for enrollment...
- patients are considered relapsed, when they progress greater than 60 days from their last dose of treatment
- patients are refractory when they progress while currently receiving the treatment or within 8 weeks of its last dose 6. Adequate hepatic function within 14 days prior to C1D1: Total bilirubin \ 60 mL/min, calculated...
- At least a 2-week interval from the last red blood cell (RBC) transfusion prior to the start of study treatment
- At least a 1-week interval from the last platelet transfusion prior to the start of study treatment
- However, patients may receive RBC and/or platelet transfusions as clinically indicated per institutional guidelines during the study 11. Female patients of childbearing potential (FCBP) must have a negative serum...
- FCBP† must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 10 - 14 days prior to and again within 24 hours of starting treatment and must either commit to continued...
What rules you out
- Patients meeting any of the following exclusion criteria are not eligible to enroll in this study:
- Patients who had prior exposure to ruxolitinib or selinexor
- Prior malignancy that required treatment or has shown evidence of recurrence (except for non-melanoma skin cancer or adequately treated cervical carcinoma in situ) during the 3 years prior to randomization. Cancer...
- Have light chain amyloidosis
- Have plasma cell leukemia
- Have history of active tuberculosis
- Have any concurrent medical condition or disease (e.g., uncontrolled active hypertension, uncontrolled active diabetes, active systemic infection, POEMS syndrome [polyneuropathy, organomegaly, endocrinopathy, monoclonal...
- Uncontrolled active infection requiring parenteral antibiotics, antivirals, or antifungals within 1 week prior to Cycle 1 Day 1 (C1D1). Patients on prophylactic antibiotics or with a controlled infection within 1 week...
- Received the following prior therapy:
- Chemotherapy within 3 weeks of study drugs
- Corticosteroids (\>20 mg/daily prednisone or equivalent) within 3 weeks of study drugs to ensure that steroid dose intensity at the beginning of the treatment is not altered by administration of steroids prior to the...
- Immunotherapy, immunomodulatory drugs, or proteasome inhibitors within 3 weeks before administration of study drugs
- Extensive radiation therapy within 28 days before study drugs. Receipt of localized radiation therapy does not preclude enrollment.
- Use of any other experimental drug or therapy within 28 days of study drugs
- Strong CYP3A4 inhibitors, strong CYP3A4 inducers and fluconazole doses \>200 mg daily within 5 half-lives before study drugs. (For example, clarithromycin has half-life of 4 hours so washout period for clarithromycin is...
- Known intolerance, hypersensitivity, or contraindication to glucocorticoids.
- Known hypersensitivity to compounds of similar chemical or biological composition to ruxolitinib or steroids.
- Concurrent use of other anti-cancer agents or treatments.
- Severe hypercalcemia, i.e., serum calcium ≥ 12 mg/dL (3.0 mmol/L) corrected for albumin
- Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
- Pregnant or breastfeeding females.
- Body surface area (BSA) \<1.4 m2 at baseline, calculated by the Dubois or Mosteller method.
- Life expectancy of less than 3 months.
- Major surgery within 4 weeks prior to C1D1.
- Active, unstable cardiovascular function, as indicated by the presence of:
- Symptomatic ischemia, or
- Uncontrolled clinically significant conduction abnormalities (e.g., patients with ventricular tachycardia on anti-arrhythmic are excluded; patients with first degree atrioventricular block or asymptomatic left anterior...
- CHF of New York Heart Association Class ≥3 or known left ventricular ejection fraction \< 40%, or
- Myocardial infarction (MI) within 3 months prior to C1D1 or
- Stroke and other thrombosis, such as, pulmonary embolism (PE) or deep vein thrombosis (DVT) within 3 months prior to C1D1.
- Any active GI dysfunction interfering with the patient's ability to swallow tablets, or any active GI dysfunction that could interfere with absorption of study treatment.
- Inability or unwillingness to take supportive medications such as anti-nausea and anti-anorexia agents as recommended by the National Comprehensive Cancer Network® (NCCN) Clinical Practice Guidelines in Oncology (CPGO)...
- Any active, serious psychiatric, medical, or other conditions/situations that, in the opinion of the Investigator, could interfere with treatment, compliance, or the ability to give informed consent.
- Contraindication to any of the required concomitant drugs or supportive treatments.
- Patients unwilling or unable to comply with the protocol.
The study team makes the final eligibility decision.
Where it's taking place
- West Hollywood, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, not specified. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include West Hollywood, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.