Selinexor Plus High-Dose Melphalan (HDM) Before Autologous Hematopoietic Cell Transplantation for Multiple Myeloma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02780609|
Recruitment Status : Recruiting
First Posted : May 23, 2016
Last Update Posted : October 3, 2019
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, 2020|
|Estimated Study Completion Date :||August 31, 2022|
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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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: Michael Dumala 813-745-7175 Michael.Dumala@moffitt.org|
|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.|
|Sub-Investigator: Omar Castaneda Puglianini, M.D.|
|Principal Investigator:||Taiga Nishihori, M.D.||H. Lee Moffitt Cancer Center and Research Institute|