Multiple Myeloma Clinical Trial

Trial of Activated Marrow Infiltrating Lymphocytes Alone or in Conjunction With an Allogeneic Granulocyte Macrophage Colony-stimulating Factor (GM-CSF)-Based Myeloma Cellular Vaccine in the Autologous Transplant Setting in Multiple Myeloma

Summary

Patient Population: Patients with active myeloma (Stage II/III) that have completed treatment-for-multiple-myeloma-induction-therapy/" >induction therapy and are eligible for an autologous stem cell transplant.

Number of Patients: Will treat a total of 32 evaluable patients in a 1:1 randomization of aMILs vs aMILs plus vaccine. An evaluable patient is defined as one which has received the activated MILs and is at least 6 months post-transplant.

Study Objectives:

Disease response as determined by the Blade' criteria will be the primary endpoint of the trial at one year.

Additional study endpoints include progression free survival, parameters of T cell reconstitution, anti-tumor immune responses as well as the effect on osteoclastogenesis and clonogenic myeloma precursor cells.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Durie-Salmon Stage II or III multiple myeloma
Newly diagnosed either prior to receiving treatment or having completed induction therapy
Relapsed myeloma not previously transplanted within the past 5 years
Measurable serum and/or urine M-protein from prior to induction therapy documented and available. A positive serum free lite assay is acceptable
Age greater than 18 years old
ECOG performance status of 0 - 2
Meet all institutional requirements for autologous stem cell transplantation
The patient must be able to comprehend and have signed the informed consent

Exclusion Criteria:

Diagnosis of any of the following plasma cell disorders: POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein [M-protein] and skin changes) Non-secretory myeloma (no measurable protein on Serum Free Lite Assay)
Plasma cell leukemia
Amyloidosis
Use of corticosteroids (glucocorticoids) within 21 days of pre-transplant vaccine or bone marrow collection
Use of any myeloma-specific therapy other than lenalidomide within 21 days of pre-transplant vaccine
In a complete remission at the time of bone marrow collection
Infection requiring treatment with antibiotics, antifungal, or antiviral agents within seven days of vaccination or bone marrow collection
Participation in any clinical trial, within four weeks prior to vaccination or bone marrow collection on this trial, which involved an investigational drug or device
History of malignancy other than multiple myeloma within five years of vaccination or bone marrow collection, except adequately treated basal or squamous cell skin cancer
Active autoimmune disease (e.g., rheumatoid arthritis, multiple sclerosis, systemic lupus erythematosis) requiring systemic treatment. Hypothyroidism without evidence of Grave's Disease or Hashimoto's thyroiditis is permitted
Evidence of spinal cord compression at time of transplant

Study is for people with:

Multiple Myeloma

Phase:

Phase 2

Estimated Enrollment:

36

Study ID:

NCT01045460

Recruitment Status:

Completed

Sponsor:

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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There is 1 Location for this study

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Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore Maryland, 21231, United States

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 2

Estimated Enrollment:

36

Study ID:

NCT01045460

Recruitment Status:

Completed

Sponsor:


Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

How clear is this clinincal trial information?

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