Melphalan and Amifostine Followed By One or Two Autologous or Syngeneic Stem Cell Transplants and Maintenance Therapy in Treating Patients With Stage II-III Multiple Myeloma
Condition: Refractory Multiple Myeloma; Stage II Multiple Myeloma; Stage III Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: melphalan; amifostine trihydrate; peripheral blood stem cell transplantation; fluorescence in situ hybridization; bone marrow ablation with stem cell support
Intervention description: Given IV; Given IV; Undergo PBSCT; Correlative study; Undergo transplant
Intervention MeSH terms: Melphalan; Amifostine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 130.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      RATIONALE: Giving chemotherapy drugs, such as melphalan, work in different ways to stop the
      growth of cancer cells, either by killing the cells or by stopping them from dividing.
      Chemoprotective drugs, such as amifostine, may protect normal cells from the side effects of
      chemotherapy. Giving chemotherapy with a peripheral stem cell transplant once or twice, using
      stem cells from the patient or an identical brother or sister, may allow more chemotherapy to
      be given so more cancer cells are killed. Giving maintenance therapy after a stem cell
      transplant may kill any cancer cells that remain. It is not yet known which dose of melphalan
      is more effective in treating multiple myeloma (MM).

      PURPOSE: This randomized phase III trial is studying two different doses of melphalan to
      compare how well they work when given together with amifostine followed by one or two
      autologous or syngeneic stem cell transplants and maintenance therapy in treating patients
      with stage II-III MM
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who have MM undergoing autologous or syngeneic hematopoietic transplantation

          -  Patients must meet Salmon and Durie criteria for initial diagnosis of MM

          -  Transplant will be offered to patients with stage II or III MM

          -  Measurable disease, defined as serum monoclonal protein >= 0.2 g/dl or Bence Jones
             protein >= 200 mg/24 h

          -  Karnofsky >= 70 or Eastern Cooperative Oncology Group (ECOG) 0-2

          -  Life expectancy is not severely limited by concomitant illness

          -  Left ventricular ejection fraction >= 50%

          -  No uncontrolled arrhythmias or symptomatic cardiac disease

          -  Forced expiratory volume in one second (FEV1), forced vital capacity (FVC), and
             diffusion capacity of carbon monoxide (DLCO) >= 50%

          -  No symptomatic pulmonary disease

          -  Human immunodeficiency virus (HIV) negative

          -  Bilirubin < 2 mg/dl

          -  Serum glutamic pyruvate transaminase (SGPT) < 2.5 x normal

          -  Creatinine clearance >= 60 cc/min, estimated or measured

          -  Signed informed consent

        Exclusion Criteria:

          -  Pregnant or lactating females

          -  Uncontrolled infection

          -  Planned tandem autologous/reduced intensity allograft

          -  Insufficient PBSC for an autologous transplant (< 3.0 x 10^6 CD34+ cells/kg total)

          -  Prior autologous transplant

          -  Non-secretory myeloma and patients who are in a complete response or near complete
             response after conventional therapy

          -  Patients unwilling to practice adequate forms of contraception if clinically indicated

          -  Male patients on study need to be consulted to use latex condoms, even if they have
             had a vasectomy, every time they have sex with a woman who is able to have children

          -  Patients with history of seizures

          -  Patients receiving antihypertensive therapy that cannot be stopped for 24 hours
             preceding amifostine treatment