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NCT01690143 · ClinicalTrials.gov registry record · Phase 1
Carfilzomib + High Dose Melphalan as Preparative Regimen for Autologous Hematopoietic Stem Cell Transplantation
A Phase 1 study of Multiple Myeloma, sponsored by University of Alabama at Birmingham.
- Completed
- Registry status
- Phase 1
- Development phase
- 45
- Enrollment target
- 4
- Study locations
NCT01690143 is a Phase 1 study of Multiple Myeloma that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 45 participants, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (92% lower). The trial reports 4 study locations across 4 states.
The verdict
NCT01690143, a Phase 1 study of Multiple Myeloma, has completed, sponsored by University of Alabama at Birmingham.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 45 participants
- Enrollment target
- 4
- Study locations
Study Summary
This study is for patients that have multiple myeloma that has come back or relapsed and their condition indicates a procedure called an Autologous Hematopoietic Stem Cell Transplantation (AHSCT). AHSCT is a procedure when stem cells from bone marrow or blood are removed before high-dose chemotherapy. Afterwards, the removed stem cells are put back into the patient's body to form a new population of blood cells. The high-dose chemotherapy administered before the AHSCT is called "Conditioning Therapy." The FDA has approved the use of the drug melphalan as a conditioning therapy. This research study will look at whether adding the study drug called carfilzomib will improve participant outcomes. Carfilzomib is considered investigational and is not approved by the FDA for the treatment of relapsed multiple myeloma. This study is divided into two phases. Phase I: Dose Escalation Phase: The main purpose of Part I of this study is to examine the safety of the study drug, carfilzomib, and determine the safest amount of the study drug that can be given to subjects who have multiple myeloma. Subjects on this study will receive different dose levels of the study drug. If you are one of the first three subjects to receive the study drug, it will be at what is called the 'starting dose' for the study which is the lowest dose that is expected to be tolerated based on prior research. After the first set of participants receive the study drug, the study doctor will review their health to see how they are tolerating the treatment. This will decide if the study drug dosage will be increased or decreased for the next set of subjects who join the study. It is anticipated that 12- 18 participants will enroll in the Phase I portion of this study. Phase II: Safety Confirmation Phase: Once the study doctor has discovered the highest possible dose of study drug that subjects can tolerate, up to 28 more subjects may be enrolled at that dose level. The main purpose of the Phase II porti
Conditions Studied
Interventions
- DRUG Melphalan
- DRUG Carfilzomib
Study Locations (4)
Alabama
- UAB - Birmingham
New York
- Memorial Sloan Kettering Cancer Center - New York
South Carolina
- Medical University of South Carolina Hollings Cancer Center - Charleston
Wisconsin
- Medical College of Wisconsin - Milwaukee
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2012-05 |
| Est. Completion | 2017-11-01 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01690143
The ClinicalTrials.gov registry entry for NCT01690143 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 45 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (92% lower). The listed sponsor is University of Alabama at Birmingham, which has 1,160 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Multiple Myeloma appearing as the primary indexed condition, and to 2 interventions - of which Melphalan is the first listed.
NCT01690143 reports 4 study locations spanning 4 distinct geographic areas - top geographies include Alabama, New York, South Carolina.
Frequently Asked Questions
What is clinical trial NCT01690143 about?
NCT01690143 is a clinical study titled "Carfilzomib + High Dose Melphalan as Preparative Regimen for Autologous Hematopoietic Stem Cell Transplantation". This study is for patients that have multiple myeloma that has come back or relapsed and their condition indicates a procedure called an Autologous Hematopoietic Stem Cell Transplantation (AHSCT). AHSCT is a procedure when stem cells from bone marrow or blood are removed before high-dose chemotherap...
What is the current status of trial NCT01690143?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 45 participants. The study started on 2012-05. Estimated completion is 2017-11-01.
What conditions does trial NCT01690143 study?
This clinical trial studies the following conditions: Multiple Myeloma.
What interventions are being tested in trial NCT01690143?
The interventions under investigation include: Melphalan (DRUG), Carfilzomib (DRUG).
Who is sponsoring clinical trial NCT01690143?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01690143 being conducted?
This trial has 4 study locations across Alabama, New York, South Carolina, Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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