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CAR T-cell Therapy
SLAMF7 FPBMC for Multiple Myeloma (MM FPBMC Trial)
Phase 1 & 2
Waitlist Available
Led By Laahn Foster, MD
Research Sponsored by University of Virginia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up about once a month during study treatment (for about 6 months), then about every 3 months for 3 years or until first progression
Awards & highlights
MM FPBMC Trial Summary
This trial is testing a new cancer treatment combining two different types of antibodies to target and kill cancer cells in patients with multiple myeloma that has returned or is not responding to other treatments. Patients receive 8-21 infusions of the treatment, given either weekly or every other week, and the effectiveness of the treatment is monitored.
Eligible Conditions
- Multiple Myeloma
MM FPBMC Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through first progression of disease (maximum of 3 years from first infusion)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through first progression of disease (maximum of 3 years from first infusion)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adverse event profile
Dose-limiting toxicities (DLTs)
Secondary outcome measures
Cellular anti-myeloma responses
Humoral anti-myeloma responses
Lymphocyte response following infusions of SLAMF7 FPBMC
+4 moreMM FPBMC Trial Design
1Treatment groups
Experimental Treatment
Group I: SLAMF7 FPBMCExperimental Treatment1 Intervention
Participants will undergo apheresis to collect cells to make SLAMF7 fresh peripheral blood mononuclear cells (FPBMC). These cells will be activated in the lab to fight against multiple myeloma. About 3-4 days after apheresis, participants will start receiving infusions of SLAMF7 FPBMC. Throughout treatment, participants will have blood taken for labs, to check disease status and also to look at immune response. Study treatment will stop if the participant has disease progression.
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Who is running the clinical trial?
University of VirginiaLead Sponsor
755 Previous Clinical Trials
1,245,291 Total Patients Enrolled
2 Trials studying Multiple Myeloma
41 Patients Enrolled for Multiple Myeloma
Laahn Foster, MDPrincipal InvestigatorUniversity of Virginia
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are allergic to elotuzumab (Elo).You have a disease that can be measured by specific lab tests within the past 28 days.You have certain specific medical conditions like amyloidosis, Waldenstrom's macroglobulinemia, or POEMS syndrome, or involvement of the central nervous system.You have a condition where your immune system attacks your own body and needed strong medication for it in the last 2 years.You have a liver disease that is currently active.You have had active tuberculosis in the past.You are able to perform daily activities without being limited by your health condition.You had another type of cancer in the last 3 years before joining the study.You are required to stay in a hospital for treatment of a mental or physical illness.You must have had at least two rounds of treatment with specific types of drugs that help the immune system, target proteins, and fight against certain cells in the body.You have been diagnosed with myeloma that has not responded to treatment or has come back after treatment.You have received anti-myeloma drug therapy (including radiation therapy) within 14 days before apheresis.Your heart's pumping ability is good, with a left ventricular ejection fraction of at least 45% at rest.You have an ongoing infection that needs medication to treat.Your heart is working well enough.You had a heart attack within the last 6 months, or you have stable or unstable chest pain.Show that your organs are working well.You have HIV, active Hepatitis C, or active Hepatitis B.You have a condition that makes you likely to bleed, except if you are currently being treated with blood-thinning medication.
Research Study Groups:
This trial has the following groups:- Group 1: SLAMF7 FPBMC
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.
What are the ultimate aims of this medical trial?
"The primary endpoint of this research is Progression-free Survival (PFS) for a period between the date of informed consent and 30 days after last BATs infusion. Secondary outcomes include Overall Survival (OS), an assessment of Adverse Event Profile, and Number of IFNgamma secreting cells as measured by Elispots."
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Are there any openings left to join this research endeavor?
"According to information available on clinicaltrials.gov, this experiment is not accepting applicants currently; the trial was originally posted December 15th 2022 and edited as recent as May 17th 2022. Although no longer enrolling, there are still 807 other trials actively recruiting patients at this moment in time."
Answered by AI
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