Selinexor Plus High-Dose Melphalan (HDM) Before Autologous Hematopoietic Cell Transplantation for Multiple Myeloma
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|ClinicalTrials.gov Identifier: NCT02780609|
Recruitment Status : Recruiting
First Posted : May 23, 2016
Last Update Posted : December 4, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Drug: Selinexor Drug: Melphalan Drug: Dexamethasone Procedure: Autologous Hematopoietic Cell Transplantation (HCT) Drug: Fosaprepitant||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||46 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 1/2 Investigator Sponsored Study of Selinexor in Combination With High-Dose Melphalan Before Autologous Hematopoietic Cell Transplantation for Multiple Myeloma|
|Actual Study Start Date :||June 26, 2017|
|Estimated Primary Completion Date :||August 31, 2019|
|Estimated Study Completion Date :||August 31, 2020|
Experimental: Selinexor Plus HDM HCT
The conditioning regimen begins 3 days prior to autologous transplant. Day 0 is the day of the autologous hematopoietic cell transplant. Melphalan will be given intravenously (IV) on Day -3 and Day -2; Dexamethasone will be given through via IV on Day -3, Day -2 and Day -1; fosaprepitant at 150 IV on days -3 and -2 will be given to patients an an antiemetic.Selinexor will be taken by mouth (PO) daily on the same day participants receive chemotherapy with melphalan.
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 Name: KPT-330
Melphalan 100 mg/m^2 IV over 30-45 minutes.
Other Name: Alkeran
Dexamethasone 20 mg PO (or IV) daily (on days -3, -2 and -1).
Other Name: Decadron
Procedure: Autologous Hematopoietic Cell Transplantation (HCT)
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.
- Phase I: Recommended Phase II Dose (RPh2D) [ 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).
- Phase II: Complete Response (CR) [ 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.
- Progression Free Survival (PFS) [ Time Frame: 3 months post HCT ]Progressive Disease (PD) as outlined by International Myeloma Working Group (IMWG) uniform response criteria by response subcategory for multiple myeloma.
- Overall Survival (OS) [ Time Frame: 3 months post HCT ]Rate of participants' survival at time of evaluation.
- Rate of Minimal Residual Disease (MRD) [ Time Frame: 3 months post HCT ]To assess minimal residual disease (MRD) with PET scan, bone marrow flow cytometry and/or immunoglobulin gene sequencing at 3 months after autologous HCT (exploratory endpoint).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02780609
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute||Recruiting|
|Tampa, Florida, United States, 33612|
|Contact: Caitlyn Ward 813-745-8986 email@example.com|
|Contact: Taiga Nishihori, M.D. 813-745-8156 firstname.lastname@example.org|
|Principal Investigator: Taiga Nishihori, M.D.|
|Principal Investigator: Daniel Sullivan, M.D.|
|Sub-Investigator: Melissa Alsina, M.D.|
|Sub-Investigator: Rachid Baz, M.D.|
|Sub-Investigator: Jose L. Ochoa-Bayona, M.D.|
|Sub-Investigator: Kenneth Shain, M.D., Ph.D.|
|Sub-Investigator: Joel Turner, Ph.D.|
|Principal Investigator:||Taiga Nishihori, M.D.||H. Lee Moffitt Cancer Center and Research Institute|