Trial Summary
What is the purpose of this trial?This early phase I trial studies the side effects of personalized vaccine in treating patients with smoldering multiple myeloma. Vaccines made from a person's blood and bone marrow may help the body build an effective immune response to kill cancer cells.
Eligibility Criteria
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.Inclusion Criteria
My condition is confirmed as smoldering multiple myeloma without any signs of further complications.
I am at intermediate or high risk of my condition worsening to multiple myeloma according to specific health criteria.
I have a diagnosis of smoldering multiple myeloma at an intermediate or high risk.
+1 more
Exclusion Criteria
I have been diagnosed with plasma cell leukemia.
Pregnant or lactating females
I have not had systemic treatment for SMM, including the prohibited ones.
+2 more
Participant Groups
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.
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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
M D Anderson Cancer CenterHouston, TX
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Who Is Running the Clinical Trial?
M.D. Anderson Cancer CenterLead Sponsor