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High-Dose Vitamin C + Low-Dose Melphalan for Multiple Myeloma
Phase 1
Recruiting
Led By Christopher Strouse, MD
Research Sponsored by Michael Tomasson
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must have progressive disease following 3 or more prior lines of therapy
Diagnosis of multiple myeloma per IMWG criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through 28 days after the end of treatment
Awards & highlights
Study Summary
This trial is testing if a low dose of melphalan combined with high doses of ascorbate acid is safe and effective in treating patients who have multiple myeloma that has returned or does not respond to treatment.
Who is the study for?
This trial is for adults with multiple myeloma who've tried at least three prior treatments, including specific inhibitors and antibodies. They must have measurable disease progression but not be suitable for other beneficial regimens. Participants need good organ function, no severe comorbidities or certain infections, and can't be on warfarin or have a history of significant kidney stones.Check my eligibility
What is being tested?
The study tests high doses of Vitamin C (ascorbic acid) combined with low dose melphalan chemotherapy in patients whose multiple myeloma has relapsed after previous treatments. It's an early-phase trial focusing on safety and initial signs of effectiveness.See study design
What are the potential side effects?
Potential side effects include those typical of chemotherapy like nausea, fatigue, hair loss, increased risk of infection due to lowered blood counts; plus possible kidney stone formation and interference with diabetes monitoring.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My condition worsened after 3 or more treatments.
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I have been diagnosed with multiple myeloma.
Select...
I have been treated with a proteasome inhibitor, an IMiD, and an anti-CD38 antibody.
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I am able to get out of my bed or chair and move around.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through 28 days after the end of treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through 28 days after the end of treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of treatment related adverse events as defined by National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03
Secondary outcome measures
Categorize and quantify adverse events compared to historical control
Overall response rate based on International Myeloma Working Group (IMWG) criteria
Oxidative stress parameters in plasma through blood testing
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Low dose melphalan + high dose ascorbate acid (HDAA)Experimental Treatment2 Interventions
Patients will receive a test dose of 15g of HDAA prior to starting treatment dose. This will be mainly to rule out allergic reactions.
HDAA + Melphalan:
HDAA on day 1 and day 4 in combination with melphalan 12.5 mg/m2, followed by 2 additional doses of HDAA on day 2 and day 5.
A 3 + 3 cohort method will be used for this study. After successfully completing the test dose, subjects will receive 50gms, 75gms and 100gms of ascorbate per infusion in 3 different cohorts. Dose modifications are not made for weight or body surface area.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Melphalan
2008
Completed Phase 3
~1500
Find a Location
Who is running the clinical trial?
Michael TomassonLead Sponsor
University of IowaOTHER
446 Previous Clinical Trials
879,493 Total Patients Enrolled
3 Trials studying Multiple Myeloma
123 Patients Enrolled for Multiple Myeloma
Christopher StrouseLead Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not a candidate for known effective treatments for my relapsed or refractory multiple myeloma.My condition worsened after 3 or more treatments.I am currently taking Coumadin (warfarin).I have had kidney stones made of oxalate or multiple kidney stones before.Women who could become pregnant must have a negative pregnancy test before starting the study.I do not have any severe health conditions that could threaten my life.I have been diagnosed with HIV.I do not have any severe illnesses or social situations that would stop me from following the study's requirements.I use a glucometer for my diabetes management.I have been diagnosed with multiple myeloma.I have been treated with a proteasome inhibitor, an IMiD, and an anti-CD38 antibody.You must have a detectable and quantifiable medical condition according to specific guidelines.My organs are functioning well.I have G6PD deficiency.You are allergic to ascorbic acid or melphalan.I have another cancer that can be treated without chemotherapy.I am able to get out of my bed or chair and move around.
Research Study Groups:
This trial has the following groups:- Group 1: Low dose melphalan + high dose ascorbate acid (HDAA)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
In what health conditions is Ascorbate typically prescribed?
"Vitamin A deficiency is regularly treated with Ascorbate. This same medication can be beneficial for addressing a variety of other maladies, including catarrh, vitamin insufficiency and amyloidosis."
Answered by AI
Are there any adverse effects associated with ingesting Ascorbate?
"Currently, the evidence of Ascorbate's safety is limited, therefore giving it a score of 1 on our scale. This assessment was made due to this being an early Phase 1 trial with only meager data pointing towards efficacy and security."
Answered by AI
What is the sample size of this research project?
"Yes, clinicaltrials.gov confirms that this trial is actively looking for participants to join the study, which was first posted on March 5th 2019 and last updated on December 31st 2021. As of now, only 9 patients are being sought at a single site."
Answered by AI
Is enrollment for this experiment open at this moment?
"Affirmative. Clinicaltrials.gov states that the research study, which was initially posted on March 5th 2019, is now recruiting participants. A total of 9 individuals are required to be recruited from 1 site."
Answered by AI
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