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Can removing certain immune cells make stem cell transplants safer for myeloma patients?

NCT ID NCT01526096

Disease control Sponsor: University of Chicago Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early study tested whether removing a specific type of immune cell (regulatory T cells) is safe in 30 people with multiple myeloma undergoing a stem cell transplant. Participants received standard transplant drugs plus a procedure to deplete these cells. The goal was to see if this could reduce complications like graft-versus-host disease. The study is complete, but results are not yet widely available.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
G-CSF, plerixafor, melphalan, and regulatory T cell depletion
What this could lead to
If successful, this approach could improve the safety and effectiveness of stem cell transplants for multiple myeloma by reducing harmful immune reactions.
What could go wrong
This is a very early (Phase 1) pilot study with only 30 participants, so results may not apply broadly. The T cell depletion could also increase infection risk or other complications.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

30 people

The number who actually took part.

Started

Jul 2011

Finished

Aug 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

21 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Symptomatic multiple myeloma of any subtype in any disease stage, providing that patient does not have smoldering myeloma. * Patient must otherwise be a candidate for ASCT as determined by treating physician. * No current CNS Myeloma at time of enrollment. * Life expectancy greater than 12 weeks. * 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. * No cardiac, pulmonary, hepatic, or renal contraindications for high dose chemotherapy. * HIV Negative. * No active Hepatitis B or C. * Patients must be able to provide written informed, consent. Exclusion Criteria: * Pregnant or nursing women. Women of child-bearing age must be tested for pregnancy. * Use of systemic immunosuppressive medications, including corticosteroids, tacrolimus, mycophenolate mofetil, sirolimus or cyclosporine A. * Psychiatric illness which may make compliance to the clinical protocol unmanageable or which may compromise the ability of the patient to give informed consent. * Active autoimmune disease including but not limited to: rheumatoid arthritis inflammatory bowel disease, celiac disease, systemic lupus erythematosis, scleroderma or multiple sclerosis.

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Conditions

The condition(s) this trial relates to.

plasma cell myeloma plasma cell neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Myeloma

Contacts and locations

Locations

  • University of Chicago

    Chicago, Illinois, 60637, United States

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