E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
adults (minimally 18 years old) that are planed to receive an autologous stem cell transplantation for a hematological malignancy (myeloma or lymphoma) |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Body processes [G] - Reproductive physiologi cal processes [G08] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The aim of this study is to examine the effect of vitamin C supplementation on immune recovery and on plasma and leukocyte concentrations of vitamin C in patients with autologous stem cell transplantation. |
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E.2.2 | Secondary objectives of the trial |
- To study the effect of AA supplementation on subpopulations of lymphocytes
- To investigate the effect of vitamin C on platelet reactivity, mitochondrial dysfunction and ROS production in CIT patients
- To investigate the effect of vitamin C on coagulation parameters and fibrinolysis in CIT patients
- To study infection rate after autologous stem cell transplantation with and without AA supplementation
- To study duration of hospital stay after autologous stem cell transplantation with and without AA supplementation
- To study overall survival after autologous stem cell transplantation with and without AA supplementation
- To study side effects of chemotherapy after autologous stem cell transplantation with and without AA supplementation
- To study quality of life after autologous stem cell transplantation with and without AA supplementation
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- 18 years or older
- written informed consent
- diagnosis of malignant lymphoma or multiple myeloma
- require chemotherapy plus autologous stem cell transplantation
- central venous catheter in place or planned
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E.4 | Principal 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
- active vitamin C supplementation other than normal daily multivitamin use
- any concurrent medical or psychiatric condition or disease that is likely to interfere with the study procedures or results, or that in the opinion of the investigator would constitute a hazard for participating in this study.
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E.5 End points |
E.5.1 | Primary end point(s) |
The main study endpoints will be the plasma AA level at day 14 and the day of repopulation (return of neutrophil to at least 0.5 × 109/l) after autologous stem cell transplantation. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Day 14 and day of neutrophile recovery |
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E.5.2 | Secondary end point(s) |
- AA plasma levels at other time points
- AA leukocyte levels
- Incidence of infections/ neutropenic fever
- Days of hospitalization
- Days with fever (≥ 38.5° C)
- Mean daily morning temperature
- Incidence of bloodstream infections i.e. bacteremia
- Type of bloodstream infections
- Quality of life according to the EORTC QLQ-C30
- Short term overall survival (3 months)
- Use of systemic antimicrobial agents (incidence and duration)
- platelet reactivity
- ROS production
- platelet mitochondrial dysfunction
- coagulation parameters
- tPA-ROTEM and fibrinolytic parameters
- number and severity of bleeding episodes during admission
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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6 weeks after the start of treatment at last visit |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |