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NCT03417284 · ClinicalTrials.gov registry record · Phase 1
Melphalan Hydrochloride in Treating Participants With Newly-Diagnosed Multiple Myeloma Undergoing Donor Stem Cell Transplantation
A Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 62
- Enrollment target
NCT03417284: Completed Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT03417284 is a Phase 1 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 62 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03417284, a Phase 1 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 62 participants
- Enrollment target
Study Summary
This phase I/II trial studies the side effects and best dose of melphalan hydrochloride in treating participants with newly-diagnosed multiple myeloma who are undergoing a donor stem cell transplantation. Giving chemotherapy before a donor stem cell transplantation helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. When the healthy stem cells from a donor are infused into the participant, they may help the participant's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Giving melphalan hydrochloride before a donor stem cell transplantation may work better than standard chemotherapy in helping to prevent multiple myeloma from coming back.
Primary Outcome
Dose limiting toxicity will be defined as grade 4 mucositis or any grade 4 or 5 non-hematologic or non-infectious toxicity occurring within 30 days from the start of infusion.
Interventions
- PROCEDURE Autologous Hematopoietic Stem Cell Transplantation
- BIOLOGICAL Filgrastim-sndz
- DRUG Melphalan Hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2019-10-09 |
| Est. Completion | 2024-07-18 |
| Phase | Phase 1 |
What the finished NCT03417284 record still lists
NCT03417284 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 62 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 3 interventions - of which Autologous Hematopoietic Stem Cell Transplantation is the first listed.
NCT03417284 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03417284 about?
NCT03417284 is a clinical study titled "Melphalan Hydrochloride in Treating Participants With Newly-Diagnosed Multiple Myeloma Undergoing Donor Stem Cell Transplantation". This phase I/II trial studies the side effects and best dose of melphalan hydrochloride in treating participants with newly-diagnosed multiple myeloma who are undergoing a donor stem cell transplantation. Giving chemotherapy before a donor stem cell transplantation helps stop the growth of cells in ...
What is the current status of trial NCT03417284?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 62 participants. The study started on 2019-10-09. Estimated completion is 2024-07-18.
What interventions are being tested in trial NCT03417284?
The interventions under investigation include: Autologous Hematopoietic Stem Cell Transplantation (PROCEDURE), Filgrastim-sndz (BIOLOGICAL), Melphalan Hydrochloride (DRUG).
Who is sponsoring clinical trial NCT03417284?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03417284's enrollment target sits among peer trials
62 824th of 2000 higher than 1,173 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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