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Cancer Vaccine

Personalized Cancer Vaccine for Multiple Myeloma

Phase < 1
Waitlist Available
Led By Krina Patel
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must have histologically confirmed SMM based on specific criteria regarding serum monoclonal protein, urinary monoclonal protein, clonal bone marrow plasma cells, and absence of myeloma defining events or amyloidosis
Patients must meet criteria for intermediate or high risk of progression to multiple myeloma by Programa para el Estudio de la Terapeutica en Hemopatía Maligna (PETHEMA) criteria, including abnormal plasma cells/total plasma cells in bone marrow compartment, immunoparesis, creatinine clearance, Eastern Cooperative Oncology Group (ECOG) performance status, absolute neutrophil count (ANC), hemoglobin, platelet count, and specific laboratory values
Must not have
Plasma cell leukemia
Prior or concurrent systemic treatment for SMM, including specific prohibited treatments and conditions
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months
Awards & highlights

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.

Who is the study for?
This trial is for adults with smoldering multiple myeloma at intermediate or high risk of progression. Participants must have certain levels of plasma cells, kidney function, and blood counts, and be able to consent. Excluded are those with active myeloma, prior SMM treatment, other cancers, infections like TB or hepatitis B/C, pregnant women, and people with HIV.
What is being tested?
The study is testing a personalized vaccine made from the patient's own blood and bone marrow to see if it can stimulate the immune system to destroy cancer cells in patients with smoldering multiple myeloma. It also involves radiography of biopsy specimens and Lenalidomide therapy.
What are the potential side effects?
Potential side effects may include typical vaccine reactions such as soreness at injection site or fever. Lenalidomide might cause fatigue, diarrhea, rash or blood clots. The body's response to the vaccine could vary widely among participants.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My condition is confirmed as smoldering multiple myeloma without any signs of further complications.
Select...
I am at intermediate or high risk of my condition worsening to multiple myeloma according to specific health criteria.
Select...
I have a diagnosis of smoldering multiple myeloma at an intermediate or high risk.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have been diagnosed with plasma cell leukemia.
Select...
I have not had systemic treatment for SMM, including the prohibited ones.
Select...
I do not have active TB, another cancer, serious infections, mental health or substance issues, HIV, or hepatitis B/C.
Select...
My condition is due to an increase in plasma cells linked to myeloma.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Clinical benefit rate (minor response or better)
Other study objectives
Immunophenotypic analysis
Rate of minimal residual disease negativity at complete remission

Trial Design

2Treatment groups
Experimental Treatment
Group I: Stage II (personalized vaccine, lenalidomide)Experimental Treatment3 Interventions
Patients undergo collection of blood and bone marrow for making the vaccine. Patients then receive personalized vaccine SC on days 1 and 15 of cycles 1-2 and on day 1 of cycles 3-6. Patients also receive lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Group II: Stage I (personalized vaccine)Experimental Treatment2 Interventions
Patients undergo collection of blood and bone marrow for making the vaccine. Patients then receive personalized vaccine SC on days 1 and 15 of cycles 1-2 and on day 1 of cycles 3-6. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lenalidomide
2005
Completed Phase 3
~1340

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,039 Previous Clinical Trials
1,799,671 Total Patients Enrolled
36 Trials studying Plasma Cell Myeloma
1,867 Patients Enrolled for Plasma Cell Myeloma
Krina PatelPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
83 Total Patients Enrolled
1 Trials studying Plasma Cell Myeloma
83 Patients Enrolled for Plasma Cell Myeloma
Elisabet E ManasanchPrincipal InvestigatorM.D. Anderson Cancer Center
4 Previous Clinical Trials
681 Total Patients Enrolled

Media Library

Vaccine Therapy (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT03631043 — Phase < 1
Plasma Cell Myeloma Research Study Groups: Stage I (personalized vaccine), Stage II (personalized vaccine, lenalidomide)
Plasma Cell Myeloma Clinical Trial 2023: Vaccine Therapy Highlights & Side Effects. Trial Name: NCT03631043 — Phase < 1
Vaccine Therapy (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03631043 — Phase < 1
~4 spots leftby Sep 2025
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