Selinexor Plus High-Dose Melphalan (HDM) Before Autologous Hematopoietic Cell Transplantation for Multiple Myeloma

Phase 1/2 Completed 22 enrolled H. Lee Moffitt Cancer Center and Research Institute Karyopharm Therapeutics Inc · collab

NaSequentialOpen-labelTreatment

Summary

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.

Timeline

Start: 2017-07-20
Primary completion: 2021-02-20
Completion: 2021-02-23

Publications

Turner JG, Cui Y, Bauer AA, Dawson JL, Gomez JA, Kim J, Cubitt CL, Nishihori T, Dalton WS, Sullivan DM. Melphalan and Exportin 1 Inhibitors Exert Synergistic Antitumor Effects in Preclinical Models of Human Multiple Myeloma. Cancer Res. 2020 Dec 1;80(23):5344-5354. doi: 10.1158/0008-5472.CAN-19-0677. Epub 2020 Oct 6.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Selinexor	Other / unclassified	40 mg	Oral
Background	Dexamethasone	Small molecule	20 mg	Oral
Background	Fosaprepitant	Other / unclassified	150 mg	Intravenous
Background	Melphalan	Small molecule	100 mg/m2	Intravenous

Selinexor Plus High-Dose Melphalan (HDM) Before Autologous Hematopoietic Cell Transplantation for Multiple Myeloma

Summary

Timeline

Publications

Drugs

Indications