QUILT-3.005: A Study of ALT-803 in Patients With Relapsed or Refractory Multiple Myeloma

ENTRY CRITERIA:

DISEASE CHARACTERISTICS:

Confirmed diagnosis of relapsed/refractory multiple myeloma after treatment with at least two different previous regimens.

Refractory disease is defined as progressive disease while on therapy or progression within 60 days of therapy.
Progressive disease is defined by a 25% increase from the lowest response value in specified tests.

Measurable disease as defined by at least one of the following:

Serum M-protein ≥ 1g/dL (for IgG, IgM) or 0.5 g/dL (for IgA)
Urine M-protein ≥ 200mg/24hours
Serum free light chains ≥ 10 mg/dL and abnormal kappa/lambda ratio

PRIOR/CONCURRENT THERAPY:

No anti-myeloma treatments within 14 days before the start of study treatment.
Must have recovered from side effects of prior treatments.

PATIENT CHARACTERISTICS:

Performance Status

• ECOG 0, 1, or 2

Bone Marrow Reserve

Absolute neutrophil count (AGC/ANC) ≥ 1000/uL
Platelets ≥ 30,000/uL
Hemoglobin ≥ 8g/dL
Absolute lymphocytes ≥ 800/uL
Leukocytes ≥ 3,000/uL

Renal Function

• Glomerular Filtration Rate (GFR) > 40mL/min or Serum creatinine ≤ 1.5 X ULN

Hepatic Function

Total bilirubin ≤ 2.0 X ULN
AST, ALT, ALP ≤ 3.0 X ULN, or ≤ 5.0 X ULN (if liver metastases exist)
No positive Hep C serology or active Hep B infection

Cardiovascular

No congestive heart failure < 6 months
No unstable angina pectoris < 6 months
No myocardial infarction < 6 months
No history of ventricular arrhythmias
No history of supraventricular arrhythmias
No NYHA Class > II CHF
No marked baseline prolongation of QT/QTc interval

Pulmonary

• Normal clinical assessment of pulmonary function

Other

Negative serum pregnancy test if female and of childbearing potential
Women who are not pregnant or nursing
Subjects, both females and males, with reproductive potential must agree to use effective contraceptive measures for the duration of the study
No known autoimmune disease other than corrected hypothyroidism
No known prior organ allograft or allogeneic transplantation
Not HIV positive
No history or evidence of uncontrollable CNS disease
No psychiatric illness/social situation
No other illness that in the opinion of the investigator would exclude the subject from participating in the study
Must provide informed consent and HIPPA authorization and agree to comply with all protocol-specified procedures and follow-up evaluations
No active systemic infection requiring parenteral antibiotic therapy
No on-going chronic systemic corticosteroid (>10 mg daily prednisone equivalent) use or other immunosuppressive therapy (a history of mild asthma not requiring therapy is eligible). Inhaled or topical steroids, and adrenal replacement steroid doses ≤ 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.