A Trial of Selinexor, Ruxolitinib and Methylprednisolone
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorOncotherapeutics
About this trial
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. Selinexor has demonstrated activity in combination with various drugs, including glucocorticoids and proteasome inhibitors, leading to its FDA approval for the treatment of relapsed or refractory multiple myeloma.
Eligibility criteria
Qualifiers
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 <40 mL per minute or serum creatinine >177mol/L (>2mg/dL)
Anemia: hemoglobin value of >20g/L below the lowest limit of normal, or a hemoglobin value <100g/L
Disqualifiers
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 treated with curative intent for >5 years previously and without evidence of recurrence will be allowed.
Have light chain amyloidosis
Have plasma cell leukemia
Trial design
Treatments tested in this trial
- Selinexor
- Ruxolitinib
- Methylprednisolone
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov