- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00504101
Bortezomib, Arsenic Trioxide, and Melphalan in Treating Patients Undergoing an Autologous Stem Cell Transplant For Multiple Myeloma
Phase I Clinical Trial of Dose Escalated Bortezomib + ATO (Arsenic Trioxide) + Melphalan as a Conditioning Regimen for Multiple Myeloma
RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as arsenic trioxide and melphalan, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving high-dose combination chemotherapy together with bortezomib may kill more cancer cells.
PURPOSE: This phase I trial is studying the side effects and best dose of bortezomib when given together with arsenic trioxide and melphalan in treating patients undergoing an autologous stem cell transplant for multiple myeloma.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
OBJECTIVES:
Primary
- Evaluate toxicity of a conditioning treatment regimen comprising bortezomib, arsenic trioxide, and melphalan.
Secondary
- Evaluate response and overall survival.
- Determine what correlative laboratory and clinical parameters, if any, are associated with efficacy (e.g., serum arsenic trioxide intracellular glutathione depletion, gene profiling of myeloma cells).
OUTLINE: This is a dose-escalation study of bortezomib.
- Conditioning regimen: Bortezomib will be given on days -6, -4, and -2, arsenic trioxide will be given on days -6, -5, -4, -3, and -2 (total of 5 doses), and melphalan will be given on day -2.
- Stem cell infusion: On day 0 a minimum of autologous 2 x 10^6 CD34 cells/kg will be infused by central catheter.
After completion of study therapy, patients are followed periodically for at least 5 years.
Type d'étude
Phase
- La phase 1
Contacts et emplacements
Lieux d'étude
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-
Florida
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Miami, Florida, États-Unis, 33136
- University of Miami Sylvester Comprehensive Cancer Center - Miami
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
DISEASE CHARACTERISTICS:
Inclusion criteria:
Confirmed diagnosis of multiple myeloma (M-protein by serum protein electrophoresis or urine protein electrophoresis) and either bone marrow biopsy and aspirate demonstrating a plasma cell count > 10% or biopsy of a bone or soft tissue mass demonstrating a plasmacytoma
- Demonstration of an indication for therapy based on symptoms (e.g., boney pain), hypercalcemia, anemia, renal insufficiency, symptomatic plasmacytomas, multiple boney lytic lesions, etc
- Stable disease or has achieved a partial remission or complete remission to pre-transplant cyto-reductive therapy
- Primary refractory disease (no response to therapy but stable) is permitted
- Candidate for high-dose chemotherapy with autologous stem cell transplantation based on stabilization of disease with preparative chemotherapy (regardless of the specific agents)
- A minimum of 2 x 10^6 CD34+ cells/kg must be collected prior to proceeding to transplant
Exclusion criteria:
- Evidence of active plasma cell leukemia
- Relapsed refractory disease (patients who have achieved at least a partial response [PR] to previous therapy and are now refractory [have not achieved a PR to subsequent therapy])
- Progressive disease on their last therapy
PATIENT CHARACTERISTICS:
Inclusion criteria:
- Karnofsky performance status 60-100%
- Creatinine < 3.0 mg/dL
- AST and ALT <2.5 times upper limit of normal
- Total bilirubin < 3 mg/dL
- WBC ≥ 2,000/mm³
- Platelet count ≥ 50,000/mm³
- If abnormal hematologic function is attributable to bone marrow infiltration by multiple myeloma, the principal investigator will decide on a case-by-case basis if the patient's bone marrow reserve is appropriate for this study
- Females of childbearing potential must have a negative serum pregnancy test prior to enrollment on the study and must use an effective barrier method while on the study
- Ejection fraction > 40% and no history of uncontrolled ischemic heart disease or congestive heart failure
- No evidence of cardiac amyloidosis by echocardiogram
- DLCO and FEV_1 ≥ 50%
Exclusion criteria:
- Active peripheral neuropathy ≥ grade 2
- Recurrent supraventricular arrhythmia or any type of sustained ventricular arrhythmia or conduction block (e.g., A-V block grade II or III, left bundle branch block)
- Known HIV infection
- Pregnant or lactating women
- Underlying medical condition that could be aggravated by the treatment or life-threatening disease unrelated to myeloma as evaluated by the enrolling physician
- History of second malignancy within the past 3 years and not in complete remission from that malignancy, excluding adequately treated basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or local prostate cancer
- History of preexisting neurological disorders (grade 2 or higher by the NCI Common Toxicity Criteria, in particular seizure disorders)
PRIOR CONCURRENT THERAPY:
Inclusion criteria:
- Previous radiation therapy for palliation of cord compression or pathologic fractures is permitted provided last dose is given 14 days prior to initiation of chemotherapy
Subjects with radiographic evidence of lytic bone disease receiving concomitant bisphosphonate therapy may be enrolled
- Bisphosphonates should be held at least 1 week prior to the transplant but continuing bisphosphonates after day +60 is at the discretion of the treating physician
Exclusion criteria:
- Previous autologous or allogeneic transplantation
- Other investigational or experimental drug or therapy while on the study
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
---|---|
Evaluate toxicity of the conditioning treatment regimen.
Délai: 3 ¼ years
|
3 ¼ years
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
---|---|
Evaluate response and overall survival (OS).
Délai: 3 ¼ years
|
3 ¼ years
|
Determine what correlative laboratory and clinical parameters, if any, are associated with efficacy
Délai: 3 ¼ years
|
3 ¼ years
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chaise d'étude: Mark S. Goodman, MD, University of Miami Sylvester Comprehensive Cancer Center
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Maladies cardiovasculaires
- Maladies vasculaires
- Maladies du système immunitaire
- Tumeurs par type histologique
- Tumeurs
- Troubles lymphoprolifératifs
- Troubles immunoprolifératifs
- Maladies hématologiques
- Troubles hémorragiques
- Troubles hémostatiques
- Paraprotéinémies
- Troubles des protéines sanguines
- Myélome multiple
- Tumeurs, plasmocyte
- Plasmocytome
- Effets physiologiques des médicaments
- Mécanismes moléculaires de l'action pharmacologique
- Agents antinéoplasiques
- Agents immunosuppresseurs
- Facteurs immunologiques
- Agents antinéoplasiques, alkylants
- Agents d'alkylation
- Agonistes myéloablatifs
- Melphalan
- Bortézomib
- Trioxyde d'arsenic
Autres numéros d'identification d'étude
- 20070104 (BiPar)
- SCCC-2006071 (Autre identifiant: University of Miami Sylvester Comprehensive Cancer Center)
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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