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Immunotherapy

Stem Cell Transplantation 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

Must not have

Active autoimmune disease including but not limited to: rheumatoid arthritis inflammatory bowel disease, celiac disease, systemic lupus erythematosis, scleroderma or multiple sclerosis

Use of systemic immunosuppressive medications, including corticosteroids, tacrolimus, mycophenolate mofetil, sirolimus or cyclosporine A

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 180 days

Awards & highlights

Approved for 5 Other Conditions

All Individual Drugs Already Approved

No Placebo-Only Group

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have an active autoimmune disease like rheumatoid arthritis or lupus.

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I am not taking any immune-suppressing drugs like steroids or tacrolimus.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 180 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~180 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 180 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Disease

Upper arm

Timing and duration of regulatory T cell depletion and recovery following autologous stem cell transplant

Secondary study objectives

Kinetics of recovery of peripheral blood cellular elements

Upper arm

Awards & Highlights

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Basiliximab

FDA approved

Filgrastim

FDA approved