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
| Status: | Completed |
|---|---|
| Conditions: | Blood Cancer, Hematology |
| Therapuetic Areas: | Hematology, Oncology |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 10/2/2013 |
| Start Date: | December 2009 |
| End Date: | December 2015 |
| Contact: | Ivan Borrello, MD |
| Email: | iborrel1@jhmi.edu |
| Phone: | 410-955-4967 |
Randomized Trial of Activated Marrow Infiltrating Lymphocytes Alone or in Conjunction With an Allogeneic GM-CSF-based Myeloma Cellular Vaccine in the Autologous Transplant Setting in Multiple Myeloma
Patient Population: Patients with active myeloma (Stage II/III) that have completed
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.
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
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Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins The name Johns Hopkins has become synonymous...
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