A Phase 2 interventional study of Vitamin C and Placebos in Myeloma Multiple and Lymphoma, sponsored by Maastricht University Medical Center. Completed at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-04-20.
Sponsored by Maastricht University Medical Center · Phase 2, Interventional, and Treatment
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.
3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.
This study's enrollment of 47 is above the median of 41 across 2,907 interventional studies indexed under Multiple Myeloma.
Browse Multiple Myeloma studies →Maastricht University Medical Center is the lead sponsor of 835 studies on the registry; 122 are open to participants now.
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Exclusion Criteria:
vitamin C intravenous during hospitalization, followed with vitamin C oral
Drug: Vitamin C
placebo intravenous during hospitalization, followed with placebo oral
Drug: Placebos
vitamin C intravenous during hospitalization, after oral, total 6 weeks.
Also known as: ascorbic acid
placebo intravenous during hospitalization, after oral, total 6 weeks
Also known as: placebo
immune recovery
the day of repopulation (return of neutrophil to at least 0.5 × 109/l) after autologous stem cell transplantation.
Time frame: day 14-28
AA plasma levels
AA plasma levels
Time frame: day 14
AA leukocyte levels
AA leukocyte levels
Time frame: day 14
Incidence of infections/ neutropenic fever
fever and infections during hospitalization
Time frame: day 1-28
Days of hospitalization
number of days patients are admitted in our hospital
Time frame: dag 1-28
Days with fever (≥ 38.5° C)
Amount of days admitted patients have a fever
Time frame: day 1-28
Incidence of bloodstream infections
number of bloodstream infections of admitted patients
Time frame: day1-28
Quality of life according to the EORTC QLQ-C30
quality of live questionaire
Time frame: Day 0, day 14, day 42
Overall survival (3 months)
overall survival at 3 months
Time frame: 3 months
Relapse rates (3 months)
relapse rate at 3 months
Time frame: 3 months
Use of systemic antimicrobial agents (incidence and duration)
use of antibiotics during hospitalization
Time frame: dau 1-28
platelet reactivity
platelet reactivity tests
Time frame: day 10
ROS production
ROS production platelets
Time frame: day 10
platelet mitochondrial dysfunction
platelet mitochondrial function test
Time frame: day 10
number and severity of bleeding episodes during admission
number and severity of bleeding episodes during admission
Time frame: day 1-28
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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Maastricht University Medical Center