Melphalan, Peripheral Stem Cell Transplantation, and Interleukin-2 Followed by Interferon Alfa in Treating Patients With Advanced Multiple Myeloma
Condition: Refractory Multiple Myeloma; Stage I Multiple Myeloma; Stage II Multiple Myeloma; Stage III Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: melphalan; recombinant interferon alfa; aldesleukin; in vitro-treated peripheral blood stem cell transplantation
Intervention description: Given IV; Given SC; Undergo IL2-treated autologous or syngeneic peripheral blood stem infusion; Undergo IL2-treated autologous or syngeneic peripheral blood stem infusion
Intervention MeSH terms: Interferons; Interferon-alpha; Aldesleukin; Interferon alpha-2; Melphalan; Interleukin-2
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Maximum age: 69 Years
Healthy volunteers: No

Summary:

      This phase II trial studies the effectiveness of melphalan, peripheral stem cell
      transplantation, and interleukin-2 followed by interferon alfa in treating patients who have
      advanced multiple myeloma (MM). Drugs used in chemotherapy use different ways to stop tumor
      cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem
      cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill
      more tumor cells. Interleukin-2 (IL2) may stimulate a person's white blood cells to kill
      multiple myeloma cells. Interferon alfa may interfere with the growth of cancer cells
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient must be less than 70 years old

          -  Patients with advanced Multiple Myeloma that meet the eligibility requirements for
             mobilization/debulking with Cytoxan/VP-16/G-CSF, Cytoxan/Taxol/G-CSF, or Cytoxan/G-CSF
             (according to protocol 506.03); if clinically indicated a lower dose of cytoxan than
             4g/m2 may be used for mobilization based on the attending's discretion; also, if the
             patients had previously collected PBSC of sufficient number in the past and meet the
             other eligibility requirements, they may be entered on this study after approval by
             the PI

          -  Patients with advanced Multiple Myeloma that have an identical syngeneic twin for
             donation of PBSCs

          -  Patients have advanced Multiple Myeloma if they were diagnosed initially with stage II
             or III disease or had stage I disease that progressed after initial therapy or failed
             to respond to therapy

          -  Syngeneic Donor Inclusion:

               -  Donor and patient have adequate documentation that donor and recipient are
                  syngeneic; including ABO typing, HLA typing and VNTR studies

               -  Donor > 20 kg

               -  Donor meets eligibility to donate according to Standard Practice Guidelines

        Exclusion Criteria:

          -  Patient's age >= 70

          -  Karnofsky score less than 80

          -  A left ventricular ejection fraction less than 50%; Patients with congestive heart
             disease, history of myocardial infarction (MI), coronary artery disease or any
             arrhythmia history

          -  Total bilirubin > 1.5 mg/ml (unless history of Gilbert's disease)

          -  Serum glutamic oxaloacetic transaminase (SGOT) or serum glutamic pyruvic transaminase
             (SGPT) > 2 x upper limit of normal

          -  Estimated creatinine clearance < 60 ml/min or creatinine serum > 2.0 mg/dl

          -  Pregnancy

          -  Seropositivity for human immunodeficiency virus

          -  Patients who cannot give informed consent

          -  Secondary malignancies other than basal cell carcinoma of the skin or carcinoma in
             situ within the last five years

          -  History of seizures or requirement for medicines, such as haldol, for controlling
             mental disorders

          -  Concurrent need for corticosteroid therapy

          -  Active connective tissue disease

          -  Pleural effusion, pericardial effusion or ascites

          -  Patients allergic to gentamicin

          -  Patients with positive PCR for hepatitis C or hepatitis B

          -  Patients with hypersensitivity to E. coli - derived preparations

          -  Patients with systemic infection at time of IL2 therapy

          -  Patients who previously have had more than 50% of their pelvic area irradiated

          -  Patients with pulmonary function tests that show diffusion capacity (corrected) < 60%,
             and/or forced expiratory volume in 1 second (FEV1) < 65% of predicted