Intervention: Melphalan
Trial phase: Phase 1 | Phase 2
ATC code: L01AA03
SMILES: N[C@@H](Cc1ccc(N(CCCl)CCCl)cc1)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 22
Group description: Autologous stem cell transplant with a conditioning regimen of melphalan 100 mg/m^2 on each of Days -2 and -1. Infusion of activated marrow infiltrating lymphocytes (MILs) on Day 3. PCV13 vaccine will be given before and/or after Day 0 depending on when participants are enrolled.
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