Myeloma MultiplePhase 2VICASTNCT03964688
Effect of Vitamin C in Autologous Stem Cell Transplantations
A Phase 2 study testing Vitamin C in people with Myeloma Multiple and Lymphoma, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myeloma Multiple, Lymphoma
- What is being tested?
- Vitamin C
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 47 participants
- Where
- 1 siteNetherlands
- Study dates
- 10 Dec 2019to 1 Mar 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial on the Effect of Vitamin C Supplementation 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.
Read the detailed description
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.
- Conditions
- Myeloma Multiple, Lymphoma
- Being tested
- Vitamin C, Placebos
- Keywords
- vitamin C, ascorbate, ascorbic acid, autologous stem cell transplantation
- Medical subject headings
- Multiple Myeloma, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin CDrug
Also called ascorbic acid
vitamin C intravenous during hospitalization, after oral, total 6 weeks.
PlacebosDrug
Also called placebo
placebo intravenous during hospitalization, after oral, total 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Vitamin C | Experimental | vitamin C intravenous during hospitalization, followed with vitamin C oral Receives: Drug: Vitamin C |
| Placebo | Experimental | placebo intravenous during hospitalization, followed with placebo oral Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
immune recovery
the day of repopulation (return of neutrophil to at least 0.5 × 109/l) after autologous stem cell transplantation.
Measured: day 14-28
Secondary outcomes (14)
AA plasma levels
AA plasma levels
Measured: day 14
AA leukocyte levels
AA leukocyte levels
Measured: day 14
Incidence of infections/ neutropenic fever
fever and infections during hospitalization
Measured: day 1-28
Days of hospitalization
number of days patients are admitted in our hospital
Measured: dag 1-28
Days with fever (≥ 38.5° C)
Amount of days admitted patients have a fever
Measured: day 1-28
Incidence of bloodstream infections
number of bloodstream infections of admitted patients
Measured: day1-28
Quality of life according to the EORTC QLQ-C30
quality of live questionaire
Measured: Day 0, day 14, day 42
Overall survival (3 months)
overall survival at 3 months
Measured: 3 months
Relapse rates (3 months)
relapse rate at 3 months
Measured: 3 months
Use of systemic antimicrobial agents (incidence and duration)
use of antibiotics during hospitalization
Measured: dau 1-28
platelet reactivity
platelet reactivity tests
Measured: day 10
ROS production
ROS production platelets
Measured: day 10
platelet mitochondrial dysfunction
platelet mitochondrial function test
Measured: day 10
number and severity of bleeding episodes during admission
number and severity of bleeding episodes during admission
Measured: day 1-28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2019
- Study start10 Dec 2019
- Primary completion1 Mar 2022
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myeloma MultipleStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- double blind placebo-controlled randomized trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gerard Bos, Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03964688
- Sponsor's protocol ID
- NL68010.068.18
- Other IDs
- 2018-004135-77, 2018
- Acronym
- VICAST
- Status last verified
- Apr 2022
- First submitted
- 9 May 2019
- Last updated
- 20 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial on the Effect of Vitamin C Supplementation in Autologous Stem Cell Transplantations
- ClinicalTrials.gov ID
- NCT03964688
- Acronym / sponsor ID
- VICAST / NL68010.068.18
- Conditions
- Myeloma Multiple, Lymphoma
- Keywords
- vitamin C, ascorbate, ascorbic acid, autologous stem cell transplantation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- 10 Dec 2019 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 28 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- double blind placebo-controlled randomized trial
| Arm | Type | Receives |
|---|---|---|
| Vitamin C | Experimental | Drug: Vitamin Cvitamin C intravenous during hospitalization, followed with vitamin C oral |
| Placebo | Experimental | Drug: Placebosplacebo intravenous during hospitalization, followed with placebo oral |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin CAlso: ascorbic acidvitamin C intravenous during hospitalization, after oral, total 6 weeks. | Drug | Vitamin C |
| PlacebosAlso: placeboplacebo intravenous during hospitalization, after oral, total 6 weeks | Drug | Placebo |
Primary outcome
immune recovery
Time frame: day 14-28
the day of repopulation (return of neutrophil to at least 0.5 × 109/l) after autologous stem cell transplantation.
14 secondary outcomes
AA plasma levels
Time frame: day 14
AA leukocyte levels
Time frame: day 14
Incidence of infections/ neutropenic fever
Time frame: day 1-28
Days of hospitalization
Time frame: dag 1-28
Days with fever (≥ 38.5° C)
Time frame: day 1-28
Incidence of bloodstream infections
Time frame: day1-28
Quality of life according to the EORTC QLQ-C30
Time frame: Day 0, day 14, day 42
Overall survival (3 months)
Time frame: 3 months
Relapse rates (3 months)
Time frame: 3 months
Use of systemic antimicrobial agents (incidence and duration)
Time frame: dau 1-28
platelet reactivity
Time frame: day 10
ROS production
Time frame: day 10
platelet mitochondrial dysfunction
Time frame: day 10
number and severity of bleeding episodes during admission
Time frame: day 1-28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gerard Bos principal investigator
Maastricht University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vitamin C in people with Myeloma Multiple and Lymphoma, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
immune recovery (time frame: day 14-28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2022.