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.