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NCT01163357 · ClinicalTrials.gov registry record · Phase 1
Bortezomib, Total Marrow Irradiation, Fludarabine Phosphate, and Melphalan in Treating Patients Undergoing Donor Peripheral Blood Stem Cell Transplant For High-Risk Stage I or II Multiple Myeloma
A Phase 1 study of Refractory Plasma Cell Myeloma and Recurrent Plasma Cell Myeloma, sponsored by City of Hope Medical Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
- 1
- Study location
NCT01163357: Completed Phase 1 study of Refractory Plasma Cell Myeloma and Recurrent Plasma Cell Myeloma, sponsored by City of Hope Medical Center.
NCT01163357 is a Phase 1 study of Refractory Plasma Cell Myeloma and Recurrent Plasma Cell Myeloma that has completed, run by City of Hope Medical Center. The registered enrollment target is 18 participants, below the 46-participant average among 25 other Refractory Plasma Cell Myeloma trials with a reported enrollment target (61% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01163357, a Phase 1 study of Refractory Plasma Cell Myeloma and Recurrent Plasma Cell Myeloma, has completed, sponsored by City of Hope Medical Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
- 1
- Study location
Study Summary
RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving chemotherapy drugs, such as fludarabine phosphate and melphalan, and total marrow irradiation before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells and helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. PURPOSE: This phase I trial is studying the side effects and best dose of bortezomib when given together with fludarabine phosphate and melphalan with or without total marrow irradiation in treating patients undergoing donor peripheral blood stem cell transplant for high-risk stage I or II multiple myeloma.
Primary Outcome
Assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Dose-limiting toxicity will be defined using Bearman Scale for events that occur.
Conditions Studied
Interventions
- DRUG fludarabine phosphate
- DRUG tacrolimus
- DRUG bortezomib
- RADIATION total marrow irradiation
- OTHER melphalan
Study Locations (1)
California
- City of Hope - Duarte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2011-01-28 |
| Est. Completion | 2024-05-20 |
| Phase | Phase 1 |
What the finished NCT01163357 record still lists
NCT01163357 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 46-participant average among 25 other Refractory Plasma Cell Myeloma trials with a reported enrollment target (61% lower).
The record links to 5 conditions, with Refractory Plasma Cell Myeloma appearing as the primary indexed condition, and to 5 interventions - of which fludarabine phosphate is the first listed.
NCT01163357 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT01163357 about?
NCT01163357 is a clinical study titled "Bortezomib, Total Marrow Irradiation, Fludarabine Phosphate, and Melphalan in Treating Patients Undergoing Donor Peripheral Blood Stem Cell Transplant For High-Risk Stage I or II Multiple Myeloma". RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving chemotherapy drugs, such as fludarabine phosphate and melphalan, and total marrow irradiation before a donor peripheral blood stem cell transplant helps stop the growth of cancer ...
What is the current status of trial NCT01163357?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2011-01-28. Estimated completion is 2024-05-20.
What conditions does trial NCT01163357 study?
This clinical trial studies the following conditions: Refractory Plasma Cell Myeloma, Recurrent Plasma Cell Myeloma, Plasma Cell Leukemia, Autologous Hematopoietic Stem Cell Transplant Recipient, Loss of Chromosome 17p.
What interventions are being tested in trial NCT01163357?
The interventions under investigation include: fludarabine phosphate (DRUG), tacrolimus (DRUG), bortezomib (DRUG), total marrow irradiation (RADIATION), melphalan (OTHER).
Who is sponsoring clinical trial NCT01163357?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01163357 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Refractory Plasma Cell Myeloma
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Where NCT01163357's enrollment target sits among peer trials
18 18th of 25 higher than 8 of 25 other Refractory Plasma Cell Myeloma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Refractory Plasma Cell Myeloma 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.
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