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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 18 months

Awards & highlights

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.

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.Check my eligibility

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.See study design

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

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My condition is confirmed as smoldering multiple myeloma without any signs of further complications.

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I am at intermediate or high risk of my condition worsening to multiple myeloma according to specific health criteria.

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I have a diagnosis of smoldering multiple myeloma at an intermediate or high risk.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Feasibility assessed by the proportion of participants for whom the vaccine is successfully developed and ready to administer

Incidence of adverse events

Secondary outcome measures

Clinical benefit rate (minor response or better)

Duration of response

Intensity and longevity of antigen specific T-cell mediated immune responses to the neoantigen vaccine

+2 more

Other outcome measures

Identification of shared human leukocyte antigen class I-restricted antigens that can be targeted with immunotherapy

Immunophenotypic analysis

Molecular and cellular profiling

+1 more

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

~1480

0 / 3Eligibility criteria met