Trial of Two Stem Cell Doses To Reduce Transplant Induced Symptom Burden
Multiple Myeloma, Primary Amyloidosis
About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring 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
Eligibility Criteria
Inclusion Criteria:
- 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
- Patients with primary amyloidosis.
- Zubrod PS of <2 or Karnofsky >/= 70.
- Left ventricular ejection fraction >/= 40%. No uncontrolled arrhythmias or symptomatic cardiac disease.
- 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.
- 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.
- HIV-negative.
- Patient is not pregnant.
- Patient or guardian able to sign informed consent.
- 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.
Sites / Locations
- University of Texas MD Anderson Cancer Center
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Standard Dose
High Dose
Melphalan + Stem Cell Infusion (Standard Dose): Standard Dose (Arm 1) = Stem cell dose of between 4-6 x 10^6 cluster of differentiation 34 (CD34)/kg on Day 0. Melphalan 100 mg/m^2 via a Central Venous Catheter (CVC) Over 15-20 Minutes on Days -3 and -2 prior to stem cell infusion. Granulocyte-colony stimulating factor (G-CSF) 5 mcg/kg given subcutaneously (under the skin) on a daily basis for approximately 10 days. Beginning Visit 1, twice a week, paper and automated phone interview of symptoms and quality of life questionnaires.
Melphalan + Stem Cell Infusion (High Dose): High Dose (Arm 2) = Stem cell dose of between 10-15 x 10^6 CD34/kg On Day 0. Melphalan 100 mg/m^2 via a Central Venous Catheter (CVC) Over 15-20 Minutes on Days -3 and -2 prior to stem cell infusion. Granulocyte-colony stimulating factor (G-CSF) 5 mcg/kg given subcutaneously (under the skin) on a daily basis for approximately 10 days. Beginning Visit 1, twice a week, paper and automated phone interview of symptoms and quality of life questionnaires.