Th1/Tc1 Immunotherapy Following Stem Cell Transplantation in Multiple Myeloma

Stopped early · Phase 1/Phase 2

Conditions studied: Myeloma, Plasma-Cell, Myeloma-Multiple, Myelomatosis

In brief

Background: \- Cancer development is associated with problems in immune system functions, which prevent the body from attacking and destroying the abnormal cells that lead to tumor growth. Research has suggested that certain white blood cells, known as Th1 (type 1 T helper cells) and Th2 T cells (type 2 T helper cells), are affected in individuals with some kinds of cancer -- when the proportion of Th2 cells is greater than Th1 cells, the immune systems ability to fight off the growth of malignant tumors is weakened. Researchers are interested in determining if an infusion of specially modified Th1 cells, in addition to stem cell transplant, is a safe and effective treatment for individuals with forms of multiple myeloma that might not respond well to standard treatments alone. Objectives: \- To determine the safety and effectiveness of the infusion of modified Th1 white blood cells, in conjunction with standard treatment, as a treatment for individuals who have been diagnosed with high-risk forms of multiple myeloma. Eligibility: * Individuals age 18 to 75 who have been newly diagnosed with high-risk multiple myeloma and who have received no or minimal treatment (Cohort A). * Individuals age 18 to 75 who have relapsed multiple myeloma, as defined by measurable disease after at least 2 prior treatment regimens. Design: * Participants will be screened with a medical history, physical examination, blood and urine tests, and imaging studies. Some participants may also have a bone marrow or other type biopsy to evaluate the state of their disease. * White blood cells will be collected from the participants through an apheresis procedure, which will collect and separate the white blood cells and return the rest of the blood to the participant. * The collected cells will be grown and expanded under special conditions in the laboratory and stored frozen until participants receive standard of care treatment for multiple myeloma, including a stem cell transplant. * Participants will receive an infusion of the modified Th1 cells a few weeks after the transplant, and will remain in the hospital for a few days after receiving the cells to monitor the possible immediate effects of the treatment. * Participants will have regular follow-up visits to study the long-term effects of the modified Th1 cell infusion.

Key facts

Study ID

NCT01239368

Run by

National Cancer Institute (NCI)

People needed

34

Starts

2010-11-10

Expected to finish

2017-08-16

Last updated by the study team

2019-12-10

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Prior allogeneic stem cell transplantation
• Hypertension not adequately controlled by 3 or less medications.
• History of cerebro-vascular accident within 6 months of enrollment.
• History of documented pulmonary embolus within 6 months of enrollment.
• Clinically significant cardiac pathology: myocardial infarction within 6 months prior to enrollment, Class III or IV heart failure according to New York Heart Association (NYHA), uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
• Patients with a history of coronary artery bypass grafting or angioplasty will receive a cardiology evaluation and be considered on a case-by-case basis.
• Human immunodeficiency virus (HIV) seropositive
• Patients known or found to be pregnant or who is unwilling to stop breast-feeding.
• Patients of childbearing age who are unwilling to practice contraception or other means of avoiding pregnancy.
• Patients may be excluded at the discretion of the principal investigator (PI) if it is deemed that allowing participation would represent an unacceptable medical or psychiatric risk.

Where it is running

• National Institutes of Health (NIH) Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States
• Hackensack University Medical Center — Hackensack, New Jersey, United States

Full record on ClinicalTrials.gov

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