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NCT02728102 · ClinicalTrials.gov registry record · Phase 2
Dendritic Cell/Myeloma Fusion Vaccine for Multiple Myeloma (BMT CTN 1401)
A Phase 2 study, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- Completed
- Registry status
- Phase 2
- Development phase
- 203
- Enrollment target
NCT02728102: Completed Phase 2 study, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
NCT02728102 is a Phase 2 study that has completed, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 203 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (53% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02728102, a Phase 2 study, has completed, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 203 participants
- Enrollment target
Study Summary
The study is designed as a Phase II, multicenter trial of vaccination with Dendritic cell/myeloma fusions with granulocyte macrophage colony-stimulating factor (GM-CSF) adjuvant plus lenalidomide maintenance therapy versus maintenance therapy alone or with GM-CSF following autologous transplant as part of upfront treatment of multiple myeloma (MM). It is hypothesized that the dendritic cell myeloma vaccine will result in improved response in patients with multiple myeloma after autologous Hematopoietic Cell Transplant (HCT).
Primary Outcome
The primary objective of this randomized trial is to compare the proportion of patients alive and in complete response (CR or sCR) at one year post transplant between patients receiving DC/myeloma vaccine/GM-CSF with lenalidomide maintenance therapy to those receiving lenalidomide maintenance therapy with or without GM-CSF. Complete Response (CR) is defined to require all the followings: Absence of the original monoclonal paraprotein in serum and urine by routine electrophoresis and by immunofix
Interventions
- DRUG Melphalan
- PROCEDURE Leukapheresis
- PROCEDURE Autologous Stem Cell Transplant
- PROCEDURE Tumor Cell Collection
- BIOLOGICAL Myeloma vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 203 participants |
| Start Date | 2016-07 |
| Est. Completion | 2022-12-09 |
| Phase | Phase 2 |
What the finished NCT02728102 record still lists
NCT02728102 is an interventional study that assigns participants to a tested intervention. The registered 203 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (53% higher).
The record links to 0 conditions, and to 5 interventions - of which Melphalan is the first listed.
NCT02728102 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02728102 about?
NCT02728102 is a clinical study titled "Dendritic Cell/Myeloma Fusion Vaccine for Multiple Myeloma (BMT CTN 1401)". The study is designed as a Phase II, multicenter trial of vaccination with Dendritic cell/myeloma fusions with granulocyte macrophage colony-stimulating factor (GM-CSF) adjuvant plus lenalidomide maintenance therapy versus maintenance therapy alone or with GM-CSF following autologous transplant as p...
What is the current status of trial NCT02728102?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 203 participants. The study started on 2016-07. Estimated completion is 2022-12-09.
What interventions are being tested in trial NCT02728102?
The interventions under investigation include: Melphalan (DRUG), Leukapheresis (PROCEDURE), Autologous Stem Cell Transplant (PROCEDURE), Tumor Cell Collection (PROCEDURE), Myeloma vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT02728102?
This trial is sponsored by National Heart, Lung, and Blood Institute (NHLBI), which has 501 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02728102's enrollment target sits among peer trials
203 301st of 2000 higher than 1,700 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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