T Cell Immunotherapy for Multiple Myeloma Patients Undergoing a Bone Marrow Transplant

NCT00048464 | Unknown Phase 1

• 1 other identifier: XT003
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 6

Brief Summary

Patients will have immune cells collected and then expanded outside of the body. Patients will undergo standard treatment with high dose chemotherapy followed by peripheral blood stem cell transplantation. Three days following the transplant, patients will receive an infusion of a large number of expanded immune cells. The goal of the study will be to determine the safety as well as potential efficacy of this treatment.

Conditions

Multiple Myeloma

Keywords

Immunotherapy; T Cell Therapy; Peripheral Blood Stem Cell Transplant; Bone marrow transplant; Adoptive immunotherapy; Xcellerate

Interventions

Infusion of Activated & Expanded Autologous T Cells PROCEDURE

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Previous diagnosis of multiple myeloma based on standard criteria. Tests need not be performed within 30 days of registration.
• Durie-Salmon Stage II or III disease at any time since diagnosis

You may not qualify if:

• Measurable serum and/or urine M-protein from prior to induction therapy documented and available
• Lymphocyte subsets by flow cytometry demonstrating CD3+ \>= 10% of the peripheral white blood cell count, and CD4+/CD8+ \>= 0.30. Test must be obtained following completion of induction therapy.
• Meets all institutional criteria for and has institutional approval to undergo autologous peripheral blood stem cell transplantation
• Age \>= 18 years old and \<=70 years old
• ECOG performance status of 0 or 1
• Life expectancy \> 6 months
• Females of child-bearing potential must have a negative serum bHCG test and be willing to use effective contraception (i.e. a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, or condom with spermicide, or abstinence) up to Day 180.
• Negative test results for current/active infection with HIV-1, HIV-2, hepatitis B, and hepatitis C within 60 days of registration.(Antibody, antigen and nucleic acid tests acceptable, depending on institutional standards.)
• Corrected serum calcium \< 11 mg/dL, and no evidence of symptomatic hypercalcemia. (Corrected serum calcium is calculated by adding 0.8 mg/dL to the measured serum calcium for every 1 g/dL that the serum albumin falls below 4.0 g/dL.)
• Serum total bilirubin and SGPT (ALT) \< 2.0 times the upper limit of normal
• Serum creatinine \< 2.0 mg/dL
• No detectable human anti-mouse antibody (HAMA) titer, and no history of allergies to mice or murine (mouse) proteins
• The patient must be able to comprehend and have signed the informed consent
• Diagnosis of any of the following cancers:
• POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein \[M-protein\] and skin changes)

Sponsors & Collaborators

• Xcyte Therapies: lead

Study Sites (6)

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

University of California, San Diego

San Diego, California, 92093, United States

Location

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Johns Hopkins Medical Institute

Baltimore, Maryland, 21231, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Hackensack University

Hackensack, New Jersey, 07601, United States

Location

Related Publications (5)

• Levine BL, Bernstein WB, Aronson NE, Schlienger K, Cotte J, Perfetto S, Humphries MJ, Ratto-Kim S, Birx DL, Steffens C, Landay A, Carroll RG, June CH. Adoptive transfer of costimulated CD4+ T cells induces expansion of peripheral T cells and decreased CCR5 expression in HIV infection. Nat Med. 2002 Jan;8(1):47-53. doi: 10.1038/nm0102-47.

  PMID: 11786906 BACKGROUND

• Thomas AK, June CH. The promise of T-lymphocyte immunotherapy for the treatment of malignant disease. Cancer J. 2001 Nov-Dec;7 Suppl 2:S67-75.

  PMID: 11777267 BACKGROUND

• June CH. Can't get any help? New approaches for adoptive immunotherapy of cancer. J Immunother. 2001 Sep-Oct;24(5):389-91. No abstract available.

  PMID: 11696694 BACKGROUND

• Frohlich, M., Grosmaire, L., Xu, J., Rasmussen, A., Roehrs, H., Lindgren, R., Ferrand, C., Tiberghien, P., Leis, J., and Bonyhadi, ML: Xcellerate: a novel autologous T cell immunotherapeutic approach for the treatment of B-cell chronic lymphocytic leukemia (B-CLL). The IX International Workshop on CLL.2002.

  BACKGROUND

• Li Q, Yu B, Grover AC, Zeng X, Chang AE. Therapeutic effects of tumor reactive CD4+ cells generated from tumor-primed lymph nodes using anti-CD3/anti-CD28 monoclonal antibodies. J Immunother. 2002 Jul-Aug;25(4):304-13. doi: 10.1097/00002371-200207000-00002.

  PMID: 12142553 BACKGROUND

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 31, 2002
• First Posted: November 4, 2002
• Study Start: October 1, 2002
• Last Updated: November 7, 2006

Record last verified: 2005-03

Locations

US (6)