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NCT02780609 · ClinicalTrials.gov registry record · Phase 1
Selinexor Plus High-Dose Melphalan (HDM) Before Autologous Hematopoietic Cell Transplantation for Multiple Myeloma
A Phase 1 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Completed
- Registry status
- Phase 1
- Development phase
- 22
- Enrollment target
NCT02780609: Completed Phase 1 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
NCT02780609 is a Phase 1 study that has completed, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 22 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02780609, a Phase 1 study, has completed, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 22 participants
- Enrollment target
Study 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.
Primary Outcome
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).
Interventions
- DRUG Melphalan
- DRUG Selinexor
- DRUG Dexamethasone
- PROCEDURE Autologous Hematopoietic Cell Transplantation (HCT)
- DRUG Fosaprepitant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2017-07-20 |
| Est. Completion | 2021-02-23 |
| Phase | Phase 1 |
What the finished NCT02780609 record still lists
NCT02780609 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% lower).
The record links to 0 conditions, and to 5 interventions - of which Melphalan is the first listed.
NCT02780609 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02780609 about?
NCT02780609 is a clinical study titled "Selinexor Plus High-Dose Melphalan (HDM) Before Autologous Hematopoietic Cell Transplantation for Multiple Myeloma". 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...
What is the current status of trial NCT02780609?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2017-07-20. Estimated completion is 2021-02-23.
What interventions are being tested in trial NCT02780609?
The interventions under investigation include: Melphalan (DRUG), Selinexor (DRUG), Dexamethasone (DRUG), Autologous Hematopoietic Cell Transplantation (HCT) (PROCEDURE), Fosaprepitant (DRUG).
Who is sponsoring clinical trial NCT02780609?
This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02780609's enrollment target sits among peer trials
22 1601st of 2000 higher than 386 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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