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Alkylating agents
Autologous Stem Cell Transplant for Multiple Myeloma
Phase 1
Recruiting
Led By Craig C Hofmeister, MD
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Left ventricular ejection fraction >= 45%
Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test prior to starting therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 90 days post-transplant
Awards & highlights
Study Summary
This trial is studying mephalan to see if it can help treat patients with multiple myeloma. It will look at what dose works best and what side effects there are.
Who is the study for?
This trial is for adults with multiple myeloma who need treatment and can undergo stem cell transplant. They must have a certain level of blood cells, kidney function, liver function, heart health, and lung capacity. Women must not be pregnant or breastfeeding and agree to contraception. People with recent disease progression, serious infections or conditions that could affect the study are excluded.Check my eligibility
What is being tested?
The trial tests different doses of Melphalan chemotherapy in patients undergoing autologous stem cell transplantation for multiple myeloma. It aims to find the best dose by measuring how the drug behaves in the body (pharmacokinetics). Participants will also complete questionnaires about their experience.See study design
What are the potential side effects?
Melphalan may cause side effects like nausea, vomiting, mouth sores, diarrhea, low blood counts leading to increased infection risk or bleeding problems. There's also a chance of allergic reactions and effects on fertility.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My heart pumps well, with an ejection fraction of 45% or higher.
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I am of childbearing age and have a negative pregnancy test.
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I have been diagnosed with a type of plasma cell disorder that needs treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 90 days post-transplant
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 90 days post-transplant
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of exposure limiting toxicity
Minimal residual disease (MRD) negativity post-transplant
Predicted versus observed total melphalan area under the curve (AUC)
Secondary outcome measures
Incidence of selected grade 3/4 toxicities at the recommended AUC range
Overall response rate
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (Melphalan-based autologous transplant)Experimental Treatment3 Interventions
Patients receive high dose (100 mg/m2) melphalan IV over 30 minutes on day -3 and PK-directed melphalan IV over 30 minutes on day -1 to achieve set cumulative melphalan exposure levels. Patients then undergo stem cell infusion on day 0.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Melphalan
2008
Completed Phase 3
~1500
Autologous Hematopoietic Stem Cell Transplantation
2017
Completed Phase 3
~1800
Find a Location
Who is running the clinical trial?
Emory UniversityLead Sponsor
1,640 Previous Clinical Trials
2,560,606 Total Patients Enrolled
25 Trials studying Multiple Myeloma
1,889 Patients Enrolled for Multiple Myeloma
Gateway for Cancer ResearchOTHER
45 Previous Clinical Trials
2,480 Total Patients Enrolled
2 Trials studying Multiple Myeloma
171 Patients Enrolled for Multiple Myeloma
National Cancer Institute (NCI)NIH
13,665 Previous Clinical Trials
40,925,764 Total Patients Enrolled
579 Trials studying Multiple Myeloma
189,041 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your lung function tests show that you can breathe well and your lungs are healthy.I have a known heart condition.You have shown signs of your disease getting worse or coming back between the time you were screened for the trial and the day you were supposed to receive melphalan treatment.My heart pumps well, with an ejection fraction of 45% or higher.I am HIV positive but have a CD4 count over 350, undetectable viral load, and am on a modern HIV treatment without ritonavir.I have undergone at least two treatments for my condition as per IMWG guidelines.I am of childbearing age and have a negative pregnancy test.I have been diagnosed with POEMS syndrome, AL amyloidosis, or Waldenstrom macroglobulinemia.My first treatment for my condition includes a transplant.If joining phase A of this study, your kidney function, measured as eGFR, must be higher than 40 mL/min.I can care for myself but may not be able to do heavy physical work.I am not pregnant or breastfeeding.I have been diagnosed with a type of plasma cell disorder that needs treatment.I have been vaccinated for hepatitis B or have recovered from it, and I don't have active hepatitis B.I have another cancer type, but it won't affect this trial's treatment.You have enough infection-fighting white blood cells in your body.I am eligible for a specific treatment dose as decided by my doctor.You have hepatitis C, unless you have successfully completed antiviral treatment and have not had the virus for at least 12 weeks.Your platelet count is at least 100,000.Your bilirubin levels in the blood are not too high, unless you have a condition called Gilbert's, in which case they can be slightly higher.Your AST and ALT levels in the blood are less than three times the normal range for the hospital where you are being treated.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (Melphalan-based autologous transplant)
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.
To what extent could Autologous Hematopoietic Stem Cell Transplantation be detrimental to a patient's health?
"Autologous Hematopoietic Stem Cell Transplantation has been granted a safety rating of 1 due to the limited evidence backing its efficacy and the lack of knowledge surrounding any potential risks."
Answered by AI
Has Autologous Hematopoietic Stem Cell Transplantation been investigated for therapeutic purposes in the past?
"Autologous Hematopoietic Stem Cell Transplantation was first trialled in 1997 at the City of Hope Comprehensive Cancer Center and since then 416 studies have been concluded. Presently, 112 ongoing trials are operating across Chicago, Illinois."
Answered by AI
What is the scope of the individuals being assessed in this experiment?
"Indeed, clinicaltrials.gov attests that this medical trial is still open for enrollment and was last updated on February 25th 2022. The investigation began soliciting participants on May 20th 2021 and requires 90 individuals from 2 study sites to reach fruition."
Answered by AI
Are any new participants still being accepted for this clinical experiment?
"According to the clinicaltrials.gov database, participation is being sought for this medical research endeavor that was first made available on May 20th 2021 and was most recently updated in February 25th 2022."
Answered by AI
To which medical conditions is Autologous Hematopoietic Stem Cell Transplantation typically applied?
"Autologous Hematopoietic Stem Cell Transplantation is the most commonly used treatment for multiple myeloma, however it can also reduce symptoms of other conditions such as hematopoietic stem cells, carcinoma and allogeneic stem cell transplant."
Answered by AI
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