Xcellerated T CellsTM in Patients With Multiple Myeloma

Sponsor

Xcyte Therapies (Industry)

Overall Status

Completed

CT.gov ID

NCT00078065

Collaborator

(none)

Enrollment

Locations

Duration (Months)

3.3

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma	Drug: Xcellerated T Cells	Phase 2

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.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

None (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

Study Start Date :

Nov 1, 2003

Study Completion Date :

Jun 1, 2004

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Oncotherapeutics	Los Angeles	California	United States	90067
2	University of California, San Diego	San Diego	California	United States	92093
3	University of California, San Francisco	San Francisco	California	United States	94143
4	Johns Hopkins Medical Institute	Baltimore	Maryland	United States	21231
5	Center for Cancer & Blood Disorders	Bethesda	Maryland	United States	20817
6	Washington University School of Medicine	St. Louis	Missouri	United States	63110
7	Hackensack University Medical Center	Hackensack	New Jersey	United States	07601
8	Oregon Health Sciences University	Portland	Oregon	United States	97239
9	Cancer Centers of the Carolinas	Greenville	South Carolina	United States	29605