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Incomplete Freund's Adjuvant · 1 trial · 2 indications
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...
Incomplete Freund's Adjuvant is used as a component of the SVN53-67/M57-KLH peptide vaccine in treating patients with newly diagnosed multiple myeloma who are receiving lenalidomide maintenance therapy. It is being studied in the context of partial response of multiple myeloma or plasma cell leukemia, an oncology indication.
Incomplete Freund's Adjuvant is developed by Bristol-Myers Squibb Company, traded under the ticker BMY. The company is conducting clinical research with this agent as part of a vaccine strategy for multiple myeloma.
Incomplete Freund's Adjuvant is in Phase 1 clinical development. It is an investigational agent being studied in an active, not recruiting trial for patients with newly diagnosed multiple myeloma. It has not been approved by regulatory authorities and remains in clinical testing.
Incomplete Freund's Adjuvant is being studied in trial NCT02334865, titled 'SVN53-67/M57-KLH Peptide Vaccine in Treating Patients With Newly Diagnosed Multiple Myeloma Receiving Lenalidomide Maintenance Therapy.' This Phase 1 trial is active but not recruiting, with an enrollment of 18 participants in the United States.
Incomplete Freund's Adjuvant is a monoclonal antibody modality used as an adjuvant in a peptide vaccine. It is designed to enhance the immune response to the SVN53-67/M57-KLH peptide, potentially helping the body target myeloma cells. The trial is biomarker-selected, indicating a focus on specific patient characteristics.