Study Summary
This trial is testing a personalized cancer vaccine to see if it is safe and if it has any side effects. The vaccine is made from a person's blood and bone marrow and it is hoped that it will help the body build an effective immune response to kill cancer cells.
Eligible Conditions
- Smoldering Plasma Cell Myeloma
Treatment Effectiveness
Phase-Based Effectiveness
Phase < 1
Study Objectives
2 Primary · 5 Secondary · Reporting Duration: Up to 18 months
Day 168
Clinical benefit rate (minor response or better)
Up to 12 months
Duration of response
Identification of shared human leukocyte antigen class I-restricted antigens that can be targeted with immunotherapy
Immunophenotypic analysis
Incidence of adverse events
Intensity and longevity of antigen specific T-cell mediated immune responses to the neoantigen vaccine
Molecular and cellular profiling
Overall survival
Rate of minimal residual disease negativity at complete remission
Up to 18 months
Time to progression
Within 12 weeks
Feasibility assessed by the proportion of participants for whom the vaccine is successfully developed and ready to administer
Trial Safety
Phase-Based Safety
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Trial Design
2 Treatment Groups
Stage I (personalized vaccine)
1 of 2
Stage II (personalized vaccine, lenalidomide)
1 of 2
Experimental Treatment
30 Total Participants · 2 Treatment Groups
Primary Treatment: Lenalidomide · No Placebo Group · Phase < 1
Stage I (personalized vaccine)Experimental Group · 2 Interventions: Biopsy Specimen Radiography, Vaccine Therapy · Intervention Types: Procedure, Biological
Stage II (personalized vaccine, lenalidomide)Experimental Group · 3 Interventions: Biopsy Specimen Radiography, Lenalidomide, Vaccine Therapy · Intervention Types: Procedure, Drug, Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lenalidomide
FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 18 months
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,849 Previous Clinical Trials
1,793,494 Total Patients Enrolled
35 Trials studying Plasma Cell Myeloma
1,821 Patients Enrolled for Plasma Cell Myeloma
Elisabet E ManasanchPrincipal InvestigatorM.D. Anderson Cancer Center
4 Previous Clinical Trials
681 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 1 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You can receive platelet and blood transfusions during the study. You can also receive growth factors like granulocyte colony stimulating factors and erythropoietin if needed.