Safety and Efficacy of Xcellerated T CellsTM in Multiple Myeloma Patients
Collecte de données
Troubles des Protéines Sanguines+12
+ Maladies Cardiovasculaires
+ Maladies Hématologiques
Étude thérapeutique
Résumé
Date de début de l'étude : 1 novembre 2003
Date à laquelle le premier participant a commencé l'étude.This study focuses on multiple myeloma, a type of cancer that affects plasma cells in the bone marrow. The main goal is to test the safety and effectiveness of a treatment called Xcellerated T CellsTM. This treatment involves using the patient's own T cells, a type of white blood cell, which are activated to fight cancer. The study is for patients who have tried one to three previous treatments that didn't work, and who haven't relapsed or worsened within a year of a stem cell transplant. The study is important as it could provide a new treatment option for multiple myeloma patients who have limited options. In this study, patients will be randomly assigned to one of two groups. One group will receive only Xcellerated T CellsTM, while the other group will receive a drug called fludarabine before the Xcellerated T CellsTM. Fludarabine is a type of chemotherapy that helps to prepare the body for the T cell treatment. A total of 30 patients will participate, with 15 in each group. After treatment, patients will be monitored for six months to see how they respond to the therapy.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.30 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.De 18 à 75 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
* 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
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 9 sites
University of California, San Diego
San Diego, United StatesUniversity of California, San Francisco
San Francisco, United StatesJohns Hopkins Medical Institute
Baltimore, United States