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Immunotherapy
Stem cell re-infusion for Multiple Myeloma
Phase 1
Waitlist Available
Led By Michael Bishop, MD
Research Sponsored by University of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age greater than or equal to 21 and less than or equal to 70 years old
EGOG performance status less than or equal to 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 180 days
Awards & highlights
Study Summary
This trial will test if it's possible and safe to reduce regulatory T-cells in people with myeloma who are undergoing stem cell transplantation.
Who is the study for?
This trial is for adults aged 21-70 with symptomatic multiple myeloma who are candidates for stem cell transplantation. They must have a life expectancy over 12 weeks, be HIV negative, not have active hepatitis B or C, and no major organ issues. Pregnant women, those on immunosuppressants or with autoimmune diseases cannot participate.Check my eligibility
What is being tested?
The study tests if it's safe to reduce regulatory T-cells in myeloma patients during autologous stem cell transplantation using drugs like G-CSF, Basiliximab and Melphalan along with techniques such as Apheresis and CliniMACS CD25 sorting.See study design
What are the potential side effects?
Possible side effects include reactions to the drug infusions (like fever or chills), bone marrow suppression leading to low blood counts, increased risk of infections due to immune system changes, and potential organ inflammation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 21 and 70 years old.
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I can do most of my daily activities on my own.
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I have symptoms of multiple myeloma but not smoldering myeloma.
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I do not have active Hepatitis B or C.
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I do not have myeloma in my brain or spinal cord.
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My heart, lungs, liver, and kidneys are healthy enough for strong chemotherapy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 180 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~180 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Disease
Upper arm
Timing and duration of regulatory T cell depletion and recovery following autologous stem cell transplant
Secondary outcome measures
Kinetics of recovery of peripheral blood cellular elements
Upper arm
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Depletion of T-cells before ASCT(Grp 3)Experimental Treatment6 Interventions
Blood collected for an ASCT will be processed using a special cell sorting machine (CliniMACS device) to remove Treg cells before the stem cells are infused back into the body during stem cell transplant.
Group II: Depletion of T-cells after ASCT (Grp 2)Experimental Treatment6 Interventions
Standard ASCT followed by treatment with basiliximab to remove certain immune cells (called regulatory T-cells or Tregs) from the blood
Group III: Standard ASCT (Grp 1)Active Control5 Interventions
Standard autologous stem cell transplantation (ASCT)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Apheresis
2003
Completed Phase 2
~660
Melphalan
FDA approved
Basiliximab
FDA approved
Filgrastim
FDA approved
Plerixafor
FDA approved
Find a Location
Who is running the clinical trial?
University of ChicagoLead Sponsor
1,001 Previous Clinical Trials
817,715 Total Patients Enrolled
16 Trials studying Multiple Myeloma
1,954 Patients Enrolled for Multiple Myeloma
Michael Bishop, MDPrincipal InvestigatorUniversity of Chicago
2 Previous Clinical Trials
93 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 21 and 70 years old.I have an active autoimmune disease like rheumatoid arthritis or lupus.My doctor has approved me for a stem cell transplant.I am not taking any immune-suppressing drugs like steroids or tacrolimus.I can do most of my daily activities on my own.I am not pregnant or nursing. If of child-bearing age, I have been tested for pregnancy.I have symptoms of multiple myeloma but not smoldering myeloma.I do not have active Hepatitis B or C.I do not have myeloma in my brain or spinal cord.My heart, lungs, liver, and kidneys are healthy enough for strong chemotherapy.
Research Study Groups:
This trial has the following groups:- Group 1: Standard ASCT (Grp 1)
- Group 2: Depletion of T-cells before ASCT(Grp 3)
- Group 3: Depletion of T-cells after ASCT (Grp 2)
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- 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.
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