Effect of Vitamin C in Autologous Stem Cell Transplantations

NCT03964688 | Completed Phase 2

• 2 other identifiers: NL68010.068.182018-004135-77
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Myeloma Multiple; Lymphoma

Keywords

vitamin C; ascorbate; ascorbic acid; autologous stem cell transplantation

Outcome Measures

Primary Outcomes (1)

• immune recovery

  the day of repopulation (return of neutrophil to at least 0.5 × 109/l) after autologous stem cell transplantation.

  day 14-28

Secondary Outcomes (14)

• AA plasma levels

  day 14

• AA leukocyte levels

  day 14

• Incidence of infections/ neutropenic fever

  day 1-28

• Days of hospitalization

  dag 1-28

• Days with fever (≥ 38.5° C)

  day 1-28

Study Arms (2)

Vitamin C

EXPERIMENTAL

vitamin C intravenous during hospitalization, followed with vitamin C oral

Drug: Vitamin C

Placebo

EXPERIMENTAL

placebo intravenous during hospitalization, followed with placebo oral

Drug: Placebos

Interventions

Vitamin C DRUG

vitamin C intravenous during hospitalization, after oral, total 6 weeks.

Also known as: ascorbic acid

Vitamin C

Placebos DRUG

placebo intravenous during hospitalization, after oral, total 6 weeks

Also known as: placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

MUMC+

Maastricht, Limburg, Netherlands

Location

MeSH Terms

Conditions

Multiple Myeloma; Lymphoma

Interventions

Ascorbic Acid

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Officials

• Gerard Bos

  Maastricht University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: double blind placebo-controlled randomized trial

Study Record Dates

• First Submitted: May 9, 2019
• First Posted: May 28, 2019
• Study Start: December 10, 2019
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2022
• Last Updated: April 20, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)