Stem Cell Transplantation for Multiple Myeloma

Recruiting in Palo Alto (17 mi)

Overseen byMichael Bishop, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: University of Chicago

No Placebo Group

Trial Summary

What is the purpose of this trial?

The purpose of this study is to test whether regulatory T-cell reduction is possible and safe in myeloma subjects undergoing autologous stem cell transplantation (ASCT).

Research Team

Michael Bishop, MD

Principal Investigator

University of Chicago

Eligibility Criteria

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.

Inclusion Criteria

I am between 21 and 70 years old.

My doctor has approved me for a stem cell transplant.

I can do most of my daily activities on my own.

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Exclusion Criteria

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

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

I am not pregnant or nursing. If of child-bearing age, I have been tested for pregnancy.

See 1 more

Treatment Details

Interventions

Regulatory T-cell reduction (Immunotherapy)

Trial OverviewThe 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.

Participant Groups

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)