Xcellerated T CellsTM in Patients With Multiple Myeloma

NCT ID: NCT00078065

Last Updated: 2005-11-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-11-30
• Study Completion Date: 2004-06-30

Brief Summary

This trial is a phase II, randomized study of patients with multiple myeloma. All patients will receive Xcellerated T Cells, with or without prior fludarabine therapy.

15 patients in each study arm will be followed for 6 months.

Detailed Description

This randomized Phase II clinical study is designed to examine the safety and efficacy of Xcellerated T CellsTM, an activated, autologous T cell product, in subjects with multiple myeloma. Subjects must have failed at least one, but no more than three, prior cytotoxic therapies prior to study registration and may not have relapsed or progressed within one year following hematopoietic stem cell transplantation. Patients will be randomized to treatment with either Xcellerated T Cells alone, or lymphoablative therapy with fludarabine followed by Xcellerated T Cells. Thirty subjects will be treated, with 15 patients in each arm. Patients will be followed for six months following treatment.

Conditions

Multiple Myeloma

Keywords

multiple myeloma; fludarabine; Xcellerated T Cells

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Xcellerated T Cells

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Previous diagnosis of multiple myeloma (MM) based on standard criteria. Tests need not be performed within 30 days of registration.
• Failure of at least one, but no more than four, prior systemic therapies for MM prior to registration and may not have relapsed or progressed within 1 year following autologous hematopoietic stem cell transplantation. Repeat courses of the same therapeutic regimen separated in time by 6 or more months are considered separate therapies. Induction therapy followed by high dose chemotherapy and autologous hematopoietic stem cell transplantation counts as one therapy.
• Measurable serum and/or urine M-protein
• Disease progression or relapse, since most recent therapy for multiple myeloma
• Age > 18 years old and < 75 years old
• ECOG performance status of 0 or 1
• 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, condom with spermicide, or abstinence) for the duration of the trial
• Negative test results for current/active infection with HIV-1, HIV-2, HTLV-1, HTLV-2, hepatitis B, and hepatitis C within 30 days of registration (Antibody, antigen, and nucleic acid tests acceptable, depending on institutional standards)
• Hemoglobin >= 10.0 g/dL. Transfusion with red blood cells or use of erythropoietin is permissible.
• White blood count (WBC) >= 3,000/mm3 and absolute neutrophil count (ANC) > 1000/mm3
• Platelet count > 75,000/mm3
• 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 alanine aminotransferase (ALT) < 2.0 times the upper limit of normal
• Serum creatinine < 2.5 mg/dL
• Serum human anti-mouse antibody (HAMA) titer undetectable or within the normal range, and no history of allergies to mice or murine (mouse) proteins
• The patient must be able to comprehend and have signed the informed consent

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xcyte Therapies

INDUSTRY

Sponsor Role: lead

Principal Investigators

Mark W Frohlich, MD

Role: STUDY_CHAIR

Xcyte Therapies

Locations

Oncotherapeutics

Los Angeles, California, United States

University of California, San Diego

San Diego, California, United States

University of California, San Francisco

San Francisco, California, United States

Johns Hopkins Medical Institute

Baltimore, Maryland, United States

Center for Cancer & Blood Disorders

Bethesda, Maryland, United States

Washington University School of Medicine

St Louis, Missouri, United States

Hackensack University Medical Center

Hackensack, New Jersey, United States

Oregon Health Sciences University

Portland, Oregon, United States

Cancer Centers of the Carolinas

Greenville, South Carolina, United States

Countries

United States

Other Identifiers

XT005

Identifier Type: -

Identifier Source: org_study_id