H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612, United States
NCT Number: NCT02780609
Phase I: The primary purpose of this study phase is to determine the best dose also referred to as the maximum tolerated dose (MTD) of Selinexor when used in combination with high-dose melphalan as a conditioning regimen for hematopoietic cell transplant.
Phase II: The primary purpose of this study phase is to assess the complete response (CR) conversion rate.
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Notify Me18 year and older
All sexes
Interventional
Phase 1 / Phase 2
Tampa, Florida, 33612, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Selinexor will be given orally 2 to 3 hours prior to high dose-melphalan IV infusion. Phase I: Dose escalation beginning with 40 mg to determine the recommended Phase II dose (RPh2D). Phase II: Treatment at RPh2D.
Other names: KPT-330
Melphalan 100 mg/m^2 IV over 30-45 minutes.
Other names: Alkeran
Dexamethasone 20 mg PO (or IV) daily (on days -3, -2 and -1).
Other names: Decadron
Participant's own stem cells are collected from their blood, frozen, then given back to them after chemotherapy.
Fosaprepitant at 150 mg IV on days -3 and -2.
Other names: antiemetic agent, Standare of Care
Time frame: Up to 3 months
RPh2D/Maximum Tolerated Dose (MTD) of Selinexor when used in combination with high-dose melphalan as a conditioning regimen for hematopoietic cell transplant. MTD: the highest dose level at which 1 or less of 6 participants experience a dose limiting toxicity (DLT).
Time frame: 3 months post HCT
Complete response (CR) conversion rate. CR: Negative immunofixation of serum and urine, disappearance of any soft tissue plasmacytomas, and ≤ 5% plasma cells in bone marrow.
tissue plasmacytomas, and ≤ 5% plasma cells in bone marrow.
Complete Response conversion rate. CR: Negative immunofixation of serum and urine, disappearance of any soft tissue plasmacytomas, and ≤ 5% plasma cells in bone marrow.
Time frame: at 24 months
Progression Free Survival defined as the time from start of treatment to the time of progression or death.
Time frame: at 24 months
Rate of participants' survival at time of evaluation.
Time frame: 3 months post HCT
Rate of participants who did not have Minimal Residual Disease (MRD) as assessed by flow cytometry.
H. Lee Moffitt Cancer Center and Research Institute
Other
Phase 1/2 Investigator Sponsored Study of Selinexor in Combination With High-Dose Melphalan Before Autologous Hematopoietic Cell Transplantation for Multiple Myeloma
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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