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Selinexor for Multiple Myeloma

Phase 1 & 2
Waitlist Available
Led By Taiga Nishihori, M.D.
Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 24 months
Awards & highlights

Study Summary

This trial is testing a new cancer treatment that combines a drug called Selinexor with high-dose melphalan. The first phase is to find the best dose of Selinexor, and the second phase is to see how well it works.

Eligible Conditions
  • Multiple Myeloma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Complete Response (CR)
Phase I: Recommended Phase II Dose (RPh2D)
Other outcome measures
Overall Survival (OS)
Phase 1 and Phase 2 Percentage of Participants Treated at Dose Level 3/RP2D With Progression Free Survival (PFS)
Rate of Minimal Residual Disease (MRD)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Selinexor Plus HDM HCTExperimental Treatment5 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Selinexor
2020
Completed Phase 2
~1360
Melphalan
2008
Completed Phase 3
~1500
Dexamethasone
2007
Completed Phase 4
~2590
Autologous Hematopoietic Cell Transplantation (HCT)
2017
Completed Phase 2
~30
Fosaprepitant
2014
Completed Phase 3
~1780

Find a Location

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
543 Previous Clinical Trials
135,473 Total Patients Enrolled
29 Trials studying Multiple Myeloma
2,091 Patients Enrolled for Multiple Myeloma
Karyopharm Therapeutics IncIndustry Sponsor
87 Previous Clinical Trials
7,557 Total Patients Enrolled
22 Trials studying Multiple Myeloma
2,198 Patients Enrolled for Multiple Myeloma
Taiga Nishihori, M.D.Principal InvestigatorH. Lee Moffitt Cancer Center and Research Institute
1 Previous Clinical Trials
30 Total Patients Enrolled
1 Trials studying Multiple Myeloma
30 Patients Enrolled for Multiple Myeloma

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
Cancer ResearchJournal
Melphalan and Exportin 1 Inhibitors Exert Synergistic Antitumor Effects in Preclinical Models of Human Multiple Myeloma
Turner, Joel G., Yan Cui, Alexis A. Bauer, Jana L. Dawson, Juan A. Gomez, Jongphil Kim, Christopher L. Cubitt, Taiga Nishihori, William S. Dalton, and Daniel M. Sullivan. 2020. “Melphalan and Exportin 1 Inhibitors Exert Synergistic Antitumor Effects in Preclinical Models of Human Multiple Myeloma”. Cancer Research. American Association for Cancer Research (AACR). doi:10.1158/0008-5472.can-19-0677.
clinicaltrials.govStudy
Selinexor Plus High-Dose Melphalan (HDM) Before Autologous Hematopoietic Cell Transplantation for Multiple Myeloma
2017. "Selinexor Plus High-Dose Melphalan (HDM) Before Autologous Hematopoietic Cell Transplantation for Multiple Myeloma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02780609.
~3 spots leftby Apr 2025
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