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A Randomized Phase II Study of Xcellerated T CellsTM With or Without Prior Fludarabine Therapy in Patients With Multiple Myeloma

Phase 2
18 Years
75 Years
Not Enrolling
Multiple Myeloma

Thank you

Trial Information

A Randomized Phase II Study of Xcellerated T CellsTM With or Without Prior Fludarabine Therapy in Patients With Multiple Myeloma

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.

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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Mark W Frohlich, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Xcyte Therapies


United States: Food and Drug Administration

Study ID:




Start Date:

November 2003

Completion Date:

June 2004

Related Keywords:

  • Multiple Myeloma
  • multiple myeloma
  • fludarabine
  • Xcellerated T Cells
  • Multiple Myeloma
  • Neoplasms, Plasma Cell



Washington University School of Medicine Saint Louis, Missouri  63110
Hackensack University Medical Center Hackensack, New Jersey  07601
Cancer Centers of the Carolinas Greenville, South Carolina  29605
University of California, San Francisco San Francisco, California  94143
Oregon Health Sciences University Portland, Oregon  
University of California, San Diego La Jolla, California  92037-1709
Johns Hopkins Medical Institute Baltimore, Maryland  21231
Center for Cancer & Blood Disorders Bethesda, Maryland  20817
Oncotherapeutics Los Angeles, California  90067