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Effect of vitamin C in autologous stem cell transplantations

Phase 1
Conditions
adults (minimally 18 years old) that are planed to receive an autologous stem cell transplantation for a hematological malignancy (myeloma or lymphoma)
Therapeutic area: Body processes [G] - Reproductive physiologi cal processes [G08]
Registration Number
EUCTR2018-004135-77-NL
Lead Sponsor
MUMC
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Recruiting
Sex
All
Target Recruitment
47
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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 34
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

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.

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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