drugset / Trial / NCT03376477
Allogeneic Myeloma GM-CSF Vaccine With Lenalidomide in Multiple Myeloma Patients in Complete or Near Complete Remission
Phase 2
Terminated
24 enrolled
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Aduro Biotech, Inc. · collabCelgene Corporation · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This study seeks to determine whether addition of an allogeneic myeloma vaccine can augment clinical responses to lenalidomide in patients with near complete remission (nCR), or complete remission (CR) leading to a significant improvement in progression-free survival.This main objective of this study is to compare the 2-year progression free survival of patients with multiple myeloma in CR or nCR, treated with lenalidomide plus an allogeneic myeloma vaccine in combination with lenalidomide (with or without Prevnar vaccine) or versus placebo in combination with lenalidomide (control arm).
Timeline
- Start
- 2019-09-23
- Primary completion
- 2024-01-02
- Completion
- 2025-05-30
Outcome
Outcome not reported
Stopped (Business): “loss of funding”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | GM-CSF vaccine | Vaccine | — | Other |
| Subject | Prevnar 13 | Vaccine | — | — |
| Background | Lenalidomide | Other / unclassified | 5 mg | Oral |
| Background | Lenalidomide | Other / unclassified | 25 mg | Oral |