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NCT01658904 · ClinicalTrials.gov registry record · Phase 1
Carfilzomib and Stem Cell Transplant for Plasma Cell Myeloma
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 1
- Development phase
- 3
- Enrollment target
NCT01658904: Clinical Trial Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT01658904 is a Phase 1 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 3 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01658904, a Phase 1 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 3 participants
- Enrollment target
Study Summary
Background: \- Plasma cell myeloma is a type of cancer that affects the plasma cells in the bone marrow. It can be difficult to treat with chemotherapy. One possible treatment combines chemotherapy with a stem cell transplant. To make this treatment more effective, researchers want to give another drug along with the transplant. This drug, carfilzomib, is often used to help treat plasma cell myeloma. However, it is not usually given along with the transplant. Researchers want to see if it is safe and effective to combine the stem cell transplant with carfilzomib, and if it improves the results of the transplant. Objectives: \- To test the safety and effectiveness of carfilzomib given with stem cell transplant for plasma cell myeloma. Eligibility: \- Individuals between 18 and 75 years of age who are having a stem cell transplant to treat plasma cell myeloma. Design: * Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. Imaging studies and a bone marrow biopsy will also be performed. * Participants will have their own stem cells collected for the transplant. The transplant will be performed according to the standard of care. * All participants will receive carfilzomib on the first 2 days after transplant. The study doctors will determine the number of additional doses that they may have. * Treatment will be monitored with frequent blood tests and imaging studies.
Primary Outcome
Engraftment failure is defined as the failure to achieve neutrophil engraftment by day 21; defined from day 0, day of autologous hematopoietic cell transplantation (AHCT), as the first of three consecutive days on which the patient's absolute neutrophil count is greater than 0.5x10(9)/l following the nadir. Transplant related mortality is defined as any subject who dies in the first 100 days post-AHCT of any non-relapse related cause.
Interventions
- DRUG Melphalan
- DRUG Carfilzomib
- DRUG Filgrastim
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2012-07 |
| Est. Completion | 2014-04 |
| Phase | Phase 1 |
Why NCT01658904 stopped before completion
NCT01658904 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 3 interventions - of which Melphalan is the first listed.
NCT01658904 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01658904 about?
NCT01658904 is a clinical study titled "Carfilzomib and Stem Cell Transplant for Plasma Cell Myeloma". Background: \- Plasma cell myeloma is a type of cancer that affects the plasma cells in the bone marrow. It can be difficult to treat with chemotherapy. One possible treatment combines chemotherapy with a stem cell transplant. To make this treatment more effective, researchers want to give another ...
What is the current status of trial NCT01658904?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 3 participants. The study started on 2012-07. Estimated completion is 2014-04.
What interventions are being tested in trial NCT01658904?
The interventions under investigation include: Melphalan (DRUG), Carfilzomib (DRUG), Filgrastim (DRUG).
Who is sponsoring clinical trial NCT01658904?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01658904's enrollment target sits among peer trials
3 1999th of 2000 higher than 1 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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