Trial of Two Stem Cell Doses To Reduce Transplant Induced Symptom Burden
Condition: Multiple Myeloma; Primary Amyloidosis
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell; Immunoglobulin Light-chain Amyloidosis; Amyloidosis
Intervention: Melphalan; Stem Cell Infusion; Questionnaires; Granulocyte-colony stimulating factor (G-CSF); Apheresis
Intervention description: 100 mg/m^2 via a Central Venous Catheter (CVC) Over 15-20 Minutes on Days -3 and -2 prior to stem cell infusion.; Stem Cell Infusion is Day 0.
Standard Dose (Arm 1) = Stem cell dose of between 4-6 x 10^6 CD34/kg On Day 0
High Dose (Arm 2) = Stem cell dose of between 10-15 x 10^6 CD34/kg On Day 0.; Beginning Visit 1, twice a week, paper and automated phone interview of symptoms and quality of life questionnaires.; 5 mcg/kg given subcutaneously (under the skin) on a daily basis for approximately 10 days.; Collection of stem cells from blood collected either through CVC or from a vein in one arm.
Intervention MeSH terms: Melphalan; Lenograstim
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 80.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: No
Keywords: Multiple Myeloma; Primary Amyloidosis; Cytokine Modulation; Melphalan; Alkeran; Transplant Induced Symptoms; Stem Cell Infusion; Autologous stem cell transplant; ASCT; Granulocyte-colony stimulating factor; G-CSF; Apheresis

Summary:

      The goal of this clinical research study is to learn whether higher doses of stem cells can
      help to decrease the symptoms that occur after melphalan. Another goal of the study is to see
      how the dose of infused stem cells affects the levels of certain proteins in your blood.
      Researchers also want to learn how the dose of stem cells that you receive affects the
      quality of your life during the weeks after the transplant procedure.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients with multiple myeloma over the age of 60 in any of the following disease
             categories: a) Primary refractory disease b) Consolidation of a first partial or
             complete remission. OR

          2. Patients with primary amyloidosis.

          3. Zubrod PS of <2 or Karnofsky >/= 70.

          4. Left ventricular ejection fraction >/= 40%. No uncontrolled arrhythmias or symptomatic
             cardiac disease.

          5. Forced expiratory volume at one second (FEV1), forced vital capacity (FVC) and
             diffusion capacity of lung for carbon monoxide (DLCO) >/= 40%. No symptomatic
             pulmonary disease.

          6. Serum bilirubin </= 2 X upper limit of normal, serum glutamate pyruvate transaminase
             (SGPT) </= 4 X upper limit of normal. No evidence of chronic active hepatitis or
             cirrhosis. No effusion or ascites >1L prior to drainage.

          7. HIV-negative.

          8. Patient is not pregnant.

          9. Patient or guardian able to sign informed consent.

         10. Have greater than or equal to 10 x 10 e 6 CD34+ cells per kg of autologous stem cells
             cryopreserved for stem cell transplantation, procured with 5 or fewer apheresis
             collections.

        Exclusion Criteria:

        1) Patients unable to perform MDASI assessments due to language or cultural barriers.