A Randomized Trial to Compare Busulfan + Melphalan 140 mg/m2 With Melphalan 200 mg/m2 as Preparative Regimen for Autologous Hematopoietic Stem Cell Transplantation for Multiple Myeloma
Condition: Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: Busulfan; Melphalan; Questionnaire; G-CSF; High Dose Melphalan; Stem cell transplant
Intervention description: Test dose (32 mg/m^2) on day -9 then 130 mg/m^2 by vein or adjusted dose on Days -7, -6, -5, and -4.; 70 mg/m2 by vein over 30 minutes minutes on Days -2 and -1.; Quality of Life (QOL) questionnaire before starting the study drugs and then once every 4 weeks after the stem cell transplant, taking about 15 minutes to complete.; Approximately 5 mcg/kg/day subcutaneously beginning on Day +5.; 200 mg/m2 by vein over 30 minutes on Day -2.; Stem cell infusion on Day 0.
Intervention MeSH terms: Melphalan; Busulfan
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 205.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Myeloma; Multiple Myeloma; Light chain Multiple Myeloma; MM; Autologous Hematopoietic Stem Cell Transplantation; Busulfan; Busulfex; Myleran; Melphalan; Alkeran; G-CSF; Filgrastim; NeupogenTM; Questionnaire; Survey; Quality of Life; QOL

Summary:

      The goal of this clinical research study is to compare Busulfex (busulfan) with or without
      Alkeran (melphalan) to learn which study therapy may be better at helping to control MM in
      patients who will receive an autologous stem cell transplant. The safety of this combination
      therapy will also be studied.

      Melphalan and busulfan are designed to damage the DNA (genetic material) of cells, which may
      cause cancer cells to die.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients with multiple myeloma in complete remission (CR), partial remission (PR), or
             very good partial remission (VGPR), or symptomatic stable disease (no evidence of
             progression) including patients with light chain MM detected in the serum by free
             light chain assay.

          2. Patients with non-secretory multiple myeloma [absence of a monoclonal protein (M
             protein) in serum as measured by electrophoresis (SPEP) and immunofixation (SIFE) and
             the absence of Bence Jones protein in the urine (UPEP) defined by use of conventional
             electrophoresis and immunofixation (UIFE) techniques] but with measurable disease on
             imaging studies like MRI, CT scan or PET scan.

          3. Who have received at least two cycles of initial systemic therapy and are within 2 to
             12 months of the first dose. Mobilization therapy is not considered initial therapy.

          4. 70 years of age or younger.

          5. Karnofsky performance score 70% or higher.

          6. Cardiac function: left ventricular ejection fraction at rest > 40% within 3 months of
             registration.

          7. Hepatic function: bilirubin < 2x the upper limit of normal and ALT and AST < 2.5x the
             upper limit of normal.

          8. Renal function: creatinine clearance of >/= 40 mL/min, estimated or calculated.

          9. Pulmonary function: DLCO, FEV1, FVC >/= 50% of predicted value (corrected for
             hemoglobin) within 3 months of registration

         10. Signed informed consent form.

        Exclusion Criteria:

          1. Patients with uncontrolled bacterial, viral or fungal infections (currently taking
             medication and progression of clinical symptoms).

          2. Patients seropositive for the human immunodeficiency virus (HIV).

          3. Patients with history of myocardial infarction within 6 months prior to enrollment or
             has New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled
             angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence
             of acute ischemia or active conduction system abnormalities.

          4. Patients participating in an investigational new drug protocol within 14 days before
             enrollment.

          5. Female patients who are pregnant (positive b-HCG) or breastfeeding.

          6. Prior stem cell transplantation allogeneic or autologous.

          7. Prior organ transplant requiring immunosuppressive therapy.