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NCT01408563 · ClinicalTrials.gov registry record · Phase 2
Reduced Intensity Double Umbilical Cord Blood Transplantation
A Phase 2 study of Multiple Myeloma and Chronic Lymphocytic Leukemia, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Phase 2
- Development phase
- 33
- Enrollment target
- 3
- Study locations
NCT01408563: Completed Phase 2 study of Multiple Myeloma and Chronic Lymphocytic Leukemia, sponsored by Massachusetts General Hospital.
NCT01408563 is a Phase 2 study of Multiple Myeloma and Chronic Lymphocytic Leukemia that has completed, run by Massachusetts General Hospital. The registered enrollment target is 33 participants, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (94% lower). The trial reports 3 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01408563, a Phase 2 study of Multiple Myeloma and Chronic Lymphocytic Leukemia, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 33 participants
- Enrollment target
- 3
- Study locations
Study Summary
This trial will use two cord blood units for transplantation using a reduced intensity regimen rather than using intense doses of chemotherapy and radiation therapy. Two cord blood units (double cord blood) are being used, as the numbers of blood cells in one unit are too few to allow successful growth of these cells. Because the risk of infection, particularly virus infection, is high after double cord blood transplant, this study seeks to reduce the rise of virus infection by using a reduced intensity regimen without a medicine called antithymocyte globulin (ATG), as used in prior cord blood transplants. Subjects will receive two chemotherapy drugs, melphalan and fludarabine, and low dose of total body radiation (one treatment) instead of the ATG. The number of patients with virus infections in this study will be compared to our prior experience using the ATG.
Primary Outcome
The one year significant infection rate (infections requiring medical intervention) after double umbilical cord blood transplant using a novel conditioning regimen of fludarabine/melphalan/low dose total body radiation. The data is shown as the number of significant infections participants experienced during the first year, measured from the start of treatment.
Conditions Studied
Interventions
- DRUG Fludarabine
- DRUG Melphalan
- RADIATION Total Body Radiation
- BIOLOGICAL Cord Blood
Study Locations (3)
Massachusetts
- Massachusetts General Hospital - Boston
- Beth Israel Deaconess Medical Center - Boston
- Dana-Farber Cancer Institute - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2011-12 |
| Est. Completion | 2017-06 |
| Phase | Phase 2 |
What the finished NCT01408563 record still lists
NCT01408563 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (94% lower).
The record links to 5 conditions, with Multiple Myeloma appearing as the primary indexed condition, and to 4 interventions - of which Fludarabine is the first listed.
NCT01408563 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT01408563 about?
NCT01408563 is a clinical study titled "Reduced Intensity Double Umbilical Cord Blood Transplantation". This trial will use two cord blood units for transplantation using a reduced intensity regimen rather than using intense doses of chemotherapy and radiation therapy. Two cord blood units (double cord blood) are being used, as the numbers of blood cells in one unit are too few to allow successful gro...
What is the current status of trial NCT01408563?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 33 participants. The study started on 2011-12. Estimated completion is 2017-06.
What conditions does trial NCT01408563 study?
This clinical trial studies the following conditions: Multiple Myeloma, Chronic Lymphocytic Leukemia, Non-Hodgkin's Lymphoma, Acute Myelogenous Leukemia, Hodgkin's Lymphoma.
What interventions are being tested in trial NCT01408563?
The interventions under investigation include: Fludarabine (DRUG), Melphalan (DRUG), Total Body Radiation (RADIATION), Cord Blood (BIOLOGICAL).
Who is sponsoring clinical trial NCT01408563?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01408563 being conducted?
This trial has 3 study locations across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Multiple Myeloma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01408563's enrollment target sits among peer trials
33 320th of 438 higher than 116 of 438 other Multiple Myeloma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Multiple 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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