Bortezomib, Total Marrow Irradiation, Fludarabine Phosphate, and Melphalan in Treating Patients Undergoing Donor Peripheral Blood Stem Cell Transplant For High-Risk Stage I or II Multiple Myeloma

Más betegség

• Major medical or psychiatric disorders that would seriously compromise patient tolerance of this regimen
• Human immunodeficiency virus (HIV) infection, active hepatitis B or C infection, or evidence of liver cirrhosis
• Active viral, bacterial or fungal infection unless adequately treated. For fungal infection, patient should have completed full course of antifungal therapy with resolution of infection.
• Patients with radiographic changes including pulmonary disease, including but not limited to: pulmonary nodules, infiltrates, pleural effusion are excluded unless cleared by pulmonary biopsy showing no evidence for pulmonary infection

Laborértékek

• Patients with renal insufficiency or cr clearance < 60 ml/min
  • DONOR: Donors will be excluded if for medical or psychological reasons they are unable to tolerate the procedure of peripheral stem cell donation

Egyéb

• Patients with peripheral neuropathy greater than grade II

• Recipient must have signed a voluntary, informed consent in accordance with institutional and federal guidelines
• Recipients must have histopathologically confirmed diagnosis of multiple myeloma
• Age:
  • Stratum I (TMI containing arm): 18-60 years of age
  • Stratum II (non TMI arm): 18-70 years of age
• Patients with primary progressive disease on induction therapy with new targeted therapies
• Relapsed/refractory disease on new targeted therapies, i.e. thalidomide, lenalidomide, bortezomib, or other new novel agents such as carfilzomib, pomalidomide
• Patients with relapsed multiple myeloma following previous autologous stem cell transplant
• Plasma cell leukemia at diagnosis
• High-risk patients with presence of chromosome 17p deletion (> 60%) in the bone marrow by fluorescence in situ hybridization (FISH); patients are not required to have prior autologous stem cell transplant
• Able to lie supine for approximately 60 minutes, the anticipated duration of each treatment session
• Performance status evaluated by Eastern Cooperative Oncology Group (ECOG) or Karnofsky Performance Scales (KPS) patients must have a score of 0-II (ECOG) or >= 70% (KPS)
• Cardiac ejection fraction >= 50% by multiple gate acquisition (MUGA) scan and/or by echocardiogram
• Forced expiratory volume in one second (FEV1) >= 50%
• Diffusing lung capacity for carbon monoxide (DLCO) >= 50%
• Creatinine clearance or glomerular filtration rate (GFR) >= 60 ml/min
• Serum bilirubin =< 2.0 mg/dl
• Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamic pyruvic transaminase (SGPT) =< 2.5 times the institutional upper limits of normal
• Pre-treatment tests must be performed within 30 days prior to enrollment
• No other medical and or psychosocial problems, which in the opinion of the primary physician or principal investigator would place the patient at unacceptable risk from this regimen
• Patients with no previous radiation or up to a maximum 2000 cGy to non thoracic-spine and rib bone lesions or < 20% of bone marrow are eligible for TMI conditioning regimen
• Patients with previous history of irradiation at any dose to thoracic-spine, ribs or >= 20% of bone marrow cannot undergo TMI and will be eligible for bortezomib, fludarabine, and melphalan regimen
  • Stratum II); patients can be enrolled on stratum II at their physician's discretion or if patients decline radiation therapy
  • DONOR: Any matched sibling donor (matched at HLA A, B, C by intermediate resolution typing and HLA-DRB1 by high resolution typing), or unmatched unrelated donor (matched at HLA A, B, C, DRB1 by high resolution typing) will be considered a suitable donor