NCT00078065

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2 multiple-myeloma

Timeline
Completed

Started Nov 2003

Shorter than P25 for phase_2 multiple-myeloma

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2003

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 18, 2004

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 20, 2004

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2004

Completed
Last Updated

November 11, 2005

Status Verified

March 1, 2005

First QC Date

February 18, 2004

Last Update Submit

November 10, 2005

Conditions

Multiple Myeloma

Keywords

multiple myelomafludarabineXcellerated T Cells

Interventions

Xcellerated T CellsDRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
* 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (9)

Oncotherapeutics

Los Angeles, California, 90067, 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

Center for Cancer & Blood Disorders

Bethesda, Maryland, 20817, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Oregon Health Sciences University

Portland, Oregon, 97239, United States

Location

Cancer Centers of the Carolinas

Greenville, South Carolina, 29605, United States

Location

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Mark W Frohlich, MD

    Xcyte Therapies

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 18, 2004

First Posted

February 20, 2004

Study Start

November 1, 2003

Study Completion

June 1, 2004

Last Updated

November 11, 2005

Record last verified: 2005-03

Locations

US(9)