Activated White Blood Cells With ASCT for Newly Diagnosed Multiple Myeloma

• Status: Completed
• Trial end date: 2018-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center; Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborator: National Cancer Institute (NCI)
• Treatments: Melphalan

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