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NCT01045460 · ClinicalTrials.gov registry record · Phase 2
Trial of Activated Marrow Infiltrating Lymphocytes Alone or in Conjunction With an Allogeneic Granulocyte Macrophage Colony-stimulating Factor (GM-CSF)-Based Myeloma Cellular Vaccine in the Autologous Transplant Setting in Multiple Myeloma
A Phase 2 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- Completed
- Registry status
- Phase 2
- Development phase
- 36
- Enrollment target
NCT01045460 is a Phase 2 study that has completed, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 36 participants.
The verdict
NCT01045460, a Phase 2 study, has completed, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 36 participants
- Enrollment target
Study Summary
Patient Population: Patients with active myeloma (Stage II/III) that have completed induction therapy and are eligible for an autologous stem cell transplant. Number of Patients: Will treat a total of 32 evaluable patients in a 1:1 randomization of aMILs vs aMILs plus vaccine. An evaluable patient is defined as one which has received the activated MILs and is at least 6 months post-transplant. Study Objectives: Disease response as determined by the Blade' criteria will be the primary endpoint of the trial at one year. Additional study endpoints include progression free survival, parameters of T cell reconstitution, anti-tumor immune responses as well as the effect on osteoclastogenesis and clonogenic myeloma precursor cells.
Interventions
- DRUG Cyclophosphamide
- BIOLOGICAL Filgrastim
- PROCEDURE Leukapheresis
- BIOLOGICAL Allogeneic Myeloma Vaccine
- BIOLOGICAL Activated marrow infiltrating lymphocytes
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2010-01-15 |
| Est. Completion | 2020-06 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01045460
The ClinicalTrials.gov registry entry for NCT01045460 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT01045460 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01045460 about?
NCT01045460 is a clinical study titled "Trial of Activated Marrow Infiltrating Lymphocytes Alone or in Conjunction With an Allogeneic Granulocyte Macrophage Colony-stimulating Factor (GM-CSF)-Based Myeloma Cellular Vaccine in the Autologous Transplant Setting in Multiple Myeloma". Patient Population: Patients with active myeloma (Stage II/III) that have completed induction therapy and are eligible for an autologous stem cell transplant. Number of Patients: Will treat a total of 32 evaluable patients in a 1:1 randomization of aMILs vs aMILs plus vaccine. An evaluable patient ...
What is the current status of trial NCT01045460?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2010-01-15. Estimated completion is 2020-06.
What interventions are being tested in trial NCT01045460?
The interventions under investigation include: Cyclophosphamide (DRUG), Filgrastim (BIOLOGICAL), Leukapheresis (PROCEDURE), Allogeneic Myeloma Vaccine (BIOLOGICAL), Activated marrow infiltrating lymphocytes (BIOLOGICAL).
Who is sponsoring clinical trial NCT01045460?
This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total clinical trials registered on ClinicalTrials.gov.
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