Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02334865 | SVN53-67/M57-KLH Peptide Vaccine in Treating Patients With Newly Diagnosed Multiple Myeloma Receiving Lenalidomide Maintenance Therapy | PHASE1 | ACTIVE NOT_RECRUITING | 18 | — | — | Apr 13, 2017 | Dec 19, 2026 | May 15, 2026 | 2 | United States |
The National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 will be used to evaluate toxicity. The maximum grade of toxicity for each category of interest will be recorded for each patient and the summary results will be tabulated by category and grade. The frequency of toxicities will also be tabulated for the regimen estimated to be the regimen-limiting toxicity.
| Arm | Type | Description |
|---|---|---|
| Group A (vaccine and week-4 lenalidomide maintenance therapy) | EXPERIMENTAL | Patients receive SVN53-67/M57-KLH peptide vaccine in incomplete Freund's adjuvant SC and sargramostim SC every 2 weeks at weeks 0, 2, 4, and 6 for up to 4 doses and then receive a booster in week 12. Beginning in week 4, patients receive lenalidomide maintenance therapy PO QD in the absence of disease progression or unacceptable toxicity. |
| Group B (vaccine and week-0 lenalidomide maintenance therapy) | EXPERIMENTAL | Patients receive SVN53-67/M57-KLH peptide vaccine in incomplete Freund's adjuvant SC and sargramostim SC every 2 weeks at weeks 4, 6, 8, and 10 for up to 4 doses and then receive a booster in week 16. Beginning in week 0, patients receive lenalidomide maintenance therapy PO QD in the absence of disease progression or unacceptable toxicity. |
| Name | Type | Description |
|---|---|---|
| Incomplete Freund's Adjuvant | BIOLOGICAL | Given SC |
| Laboratory Biomarker Analysis | OTHER | Correlative studies |
| Lenalidomide | DRUG | Given PO |
| Sargramostim | BIOLOGICAL | Given SC |
| SVN53-67/M57-KLH Peptide Vaccine | BIOLOGICAL | Given SC |
Inclusion Criteria: * Able to adhere to the study visit schedule and other protocol requirements * Patients with newly diagnosed multiple myeloma who have at least a partial response after induction therapy based on the International Working Group (IWG) Uniform Response Criteria * Eastern Cooperati...