drugset / Trial / NCT02728102
Dendritic Cell/Myeloma Fusion Vaccine for Multiple Myeloma (BMT CTN 1401)
Phase 2
Completed
203 enrolled
National Heart, Lung, and Blood Institute (NHLBI)
Blood and Marrow Transplant Clinical Trials Network · collabNational Cancer Institute (NCI) · collabNational Marrow Donor Program · collab
RandomizedParallel-groupOpen-labelTreatment
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).
Timeline
- Start
- 2016-07
- Primary completion
- 2020-06-30
- Completion
- 2022-12-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dendritic Cell Fusion Vaccine | Vaccine | 3e+06 cells | Subcutaneous |
| Subject | sargramostim | Protein / enzyme biologic | 100 ug | Subcutaneous |
| Background | Lenalidomide | Other / unclassified | 10 mg | — |
| Background | Melphalan | Small molecule | 200 mg/m2 | — |