Effect of Vitamin C in Autologous Stem Cell Transplantations
Effect of Vitamin C in Autologous Stem Cell Transplantations
In the study the investigators will randomize patients that receive an autologous stem cell
 transplantation for myeloma or lymphoma for treatment with vitamin C or placebo during 6
 weeks. Primary endpoint will be immune recovery.
Rationale: Recent studies showed that ascorbic acid (AA) stimulates proliferation and
 maturation of T lymphocytes and natural killer (NK) cells. Chemotherapy results in depletion
 of those cells and thereby an increased infection rate. A pilot study showed low levels of AA
 in the plasma of several patients after chemotherapy followed by autologous stem cell
 transplantation for hematological malignancies. AA supplementation could be beneficial to the
 recovery of the immune system in these patients.

 Objective: The aim of this study is to examine the effect of vitamin C supplementation on
 immune recovery in patients with autologous stem cell transplantation. The aim of the run-in
 phase of the study is to examine the effect of intravenous vitamin C supplementation on
 plasma concentrations of vitamin C in patients with autologous stem cell transplantation at
 day 14 in order to be sure that in the intervention study accurate AA plasma levels will be
 present.

 Study design: run-in phase, followed by randomized controlled trial Study population: All
 participants will be adults (minimally 18 years old) that are planed to receive an autologous
 stem cell transplantation for multiple myeloma or lymphoma and are recruited at the MUMC+. In
 total there will be 3 expected (run-in phase) + 44 (randomized controlled trial)
 participants.

 Main study parameters/endpoints: Primary endpoints will be AA plasma level on day 14 (run-in
 phase) and the day of neutrophil recovery after stem cell transplantation
 (randomized-controlled phase). Secondary endpoints will be AA leukocyte levels, infection
 rate, duration of hospital stay, side effects of chemotherapy, overall survival, coagulation
 parameters, platelet reactivity, fibrinolysis and quality of life.

 Nature and extent of the burden and risks associated with participation, benefit and group
 relatedness:

 AA supplementation could be beneficial for the immune recovery in the participants of this
 study. The risks associated with participation in this study are low. Vitamin C
 supplementation is safe and hardly has any documented side effects.
Inclusion Criteria:

 -  18 years or older

 -  written informed consent

 -  diagnosis of malignant lymphoma or multiple myeloma

 -  require chemotherapy plus autologous stem cell transplantation as standard of care for
 the disease at that stage

 -  central venous catheter in place or planned

 Exclusion Criteria:

 -  inability to understand the nature and extent of the trial and the procedures required

 -  history of kidney stones

 -  kidney failure requiring dialysis or eGFR <30 mL/min. (CDK-EPI formula)

 -  history of G6PD deficiency

 -  life expectancy < 1 month

 -  use of immunosuppressive medication other than chemotherapy and corticosteroids