Xcellerated T CellsTM in Patients With Multiple Myeloma - Full Text View

Sponsor:	Xcyte Therapies
Information provided by:	Xcyte Therapies
ClinicalTrials.gov Identifier:	NCT00078065

Purpose

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.

Condition	Intervention	Phase
Multiple Myeloma	Drug: Xcellerated T Cells	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Control: Uncontrolled Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Randomized Phase II Study of Xcellerated T CellsTM With or Without Prior Fludarabine Therapy in Patients With Multiple Myeloma

Resource links provided by NLM:

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Cancer Multiple Myeloma

Drug Information available for: Fludarabine

U.S. FDA Resources

Further study details as provided by Xcyte Therapies:

Estimated Enrollment:	30
Study Start Date:	November 2003
Estimated Study Completion Date:	June 2004

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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00078065

Locations

United States, California
Oncotherapeutics
Los Angeles, California, United States, 90067
University of California, San Diego
San Diego, California, United States, 92093
University of California, San Francisco
San Francisco, California, United States, 94143
United States, Maryland
Johns Hopkins Medical Institute
Baltimore, Maryland, United States, 21231
Center for Cancer & Blood Disorders
Bethesda, Maryland, United States, 20817
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
United States, New Jersey
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
United States, Oregon
Oregon Health Sciences University
Portland, Oregon, United States, 97239
United States, South Carolina
Cancer Centers of the Carolinas
Greenville, South Carolina, United States, 29605

Sponsors and Collaborators

Xcyte Therapies

Investigators

Study Chair:

Mark W Frohlich, MD

Xcyte Therapies

More Information

No publications provided

Study ID Numbers:	XT005
Study First Received:	February 18, 2004
Last Updated:	November 10, 2005
ClinicalTrials.gov Identifier:	NCT00078065 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Xcyte Therapies:

multiple myeloma
fludarabine
Xcellerated T Cells

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Immunoproliferative Disorders
Immune System Diseases
Blood Protein Disorders
Hematologic Diseases
Vascular Diseases
Paraproteinemias

Hemostatic Disorders
Multiple Myeloma
Neoplasms
Hemorrhagic Disorders
Cardiovascular Diseases
Lymphoproliferative Disorders
Neoplasms, Plasma Cell

ClinicalTrials.gov processed this record on March 18, 2010