Multiple Myeloma Clinical Trial
Activated White Blood Cells With ASCT for Newly Diagnosed Multiple Myeloma
Summary
RATIONALE: Activating white blood cells in the laboratory may help them kill more cancer cells when they are put back in the body. This may be an effective treatment for patients undergoing a stem cell transplant for multiple myeloma.
PURPOSE: This phase I/II trial is studying the side effects of activated white blood cells and to see how well they work in treating patients who are undergoing a stem cell transplant for newly diagnosed stage II or stage III multiple myeloma.
Full Description
OBJECTIVES:
Primary
Evaluate the safety and response rate of activated marrow infiltrating lymphocytes (aMILs) in patients undergoing autologous peripheral blood stem cell transplantation for newly diagnosed, stage II-III multiple myeloma.
Determine the overall in vitro fold-expansion and assess pre- and post-expansion for myeloma T-cell specificity in assessing the feasibility of generating aMILs from myeloma patients.
Assess the toxicity of aMILs.
Evaluate the effect of aMILs on hematopoietic engraftment, including neutrophil engraftment, platelet engraftment, and primary graft failure (if failure occurs).
Evaluate response rates utilizing the Blade criteria, including the complete response (CR) rate, near complete response (nCR) rate, very good partial response (VGPR) rate, partial response (PR) rate, minimal response (MR) rate, and overall response rate (CR, VGPR, PR, MR).
Secondary
Evaluate T-cell reconstitution, including absolute lymphocyte counts, CD3+, CD4+, and CD8+ T-cell counts.
Evaluate progression-free survival and overall survival.
Evaluate anti-tumor immune response.
Determine pneumococcal-specific vaccine responses.
Determine delayed-type hypersensitivity (DTH) responses.
OUTLINE: Patients undergo collection of marrow infiltrating lymphocytes (MILs)* either at diagnosis prior to the initiation of induction therapy or upon completion of induction therapy. The MILs bone marrow product undergo ex vivo activation and expansion of T cells for 7-8 days to produce activated marrow infiltrating lymphocytes (aMILs). Patients then undergo stem cell mobilization and leukapheresis to collect the peripheral blood stem cells 12 days after mobilization. Patients receive melphalan IV over 20-30 minutes on days -2 and -1 and undergo a peripheral blood stem cell transplantation on day 0 as planned. Patients receive aMILs infusion on day 3. Patients receive pneumococcal polyvalent vaccine on day 21.
NOTE: *Patients who have completed induction therapy receive pneumococcal polyvalent vaccine approximately 2 weeks prior to MILs collection; patients undergoing MILs collection prior to starting induction therapy do not receive a pre-transplantation vaccine.
Blood and bone marrow samples are collected periodically for laboratory correlative studies.
After completion of study treatment, patients are followed periodically for up to 1 year.
Eligibility Criteria
DISEASE CHARACTERISTICS:
Diagnosis of multiple myeloma
Newly diagnosed disease
Durie-Salmon stage II or III disease
Measurable disease, defined by any of the following:
Measurable serum and/or urine M-protein levels documented and available prior to induction therapy
Positive serum free light chain assay
Must have completed a minimum of 3 courses of myeloma specific therapy
Candidate for autologous stem cell transplantation
Patients who have achieved a complete remission at the time of bone marrow harvest for marrow infiltrating lymphocytes (MILs) expansion are not eligible
No evidence of spinal cord compression
Diagnosis of the following cancers are not allowed:
POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes)
Non-secretory myeloma (no measurable protein on serum free light chain assay)
Plasma cell leukemia
No amyloidosis
PATIENT CHARACTERISTICS:
ECOG performance status 0-2
Life expectancy ≥ 6 months
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and up to day 180
Corrected serum calcium < 11 mg/dL and no evidence of symptomatic hypercalcemia
Total bilirubin ≤ 2.0 times upper limit of normal (ULN)
ALT ≤ 2.0 times ULN
Serum creatinine < 2.0 mg/dL
No history of other malignancy within the past 5 years, except adequately treated basal cell or squamous cell skin cancer
No history of autoimmune disease (e.g., rheumatoid arthritis, multiple sclerosis, systemic lupus erythematosus) requiring systemic treatment
Hypothyroidism without evidence of Graves' disease or Hashimoto thyroiditis is allowed
No infection requiring treatment with antibiotics, antifungal, or antiviral agents within the past 7 days
No HIV infection
No major organ system dysfunction including, but not limited to, the following:
New York Heart Association class III or IV congestive heart failure
Pulmonary disease requiring the use of inhaled steroids or bronchodilators
Renal, hepatic, gastrointestinal, neurologic, or psychiatric dysfunction that would impair ability to participate in the study
PRIOR CONCURRENT THERAPY:
See Disease Characteristics
No prior hematopoietic stem cell transplantation
At least 3 weeks since prior corticosteroids (i.e., glucocorticoids)
At least 3 weeks since prior myeloma-specific therapy
At least 4 weeks since participation in any clinical trial that involved an investigational drug or device
No concurrent therapy with any of the following:
Corticosteroids (e.g., hydrocortisone, prednisone, prednisolone, dexamethasone [Decadron])
Inhaled steroids used for treatment of allergic rhinitis or pulmonary disease allowed
Thalidomide
Interferon
Growth factors, interleukins, or other cytokines (except filgrastim [G-CSF] as outlined in the protocol, or erythropoietin)
Cytotoxic chemotherapy agents (except cyclophosphamide for stem cell mobilization and high-dose melphalan)
Immunosuppressive drugs
Experimental therapies
Radiotherapy
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There is 1 Location for this study
Baltimore Maryland, 21231, United States
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