- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00288028
Bortezomib in Treating Patients With Multiple Myeloma Who Have Undergone an Autologous Peripheral Blood Stem Cell Transplant
A Phase I Study of Bortezomib During Maintenance Phase After High Dose Melphalan and Autologous Stem Cell Transplantation in Patients With Multiple Myeloma
RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving bortezomib after an autologous peripheral blood stem cell transplant may stop the growth of any cancer cells that remain after transplant.
PURPOSE: This phase I trial is studying the side effects and best dose of bortezomib in treating patients with multiple myeloma who have undergone an autologous peripheral blood stem cell transplant.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
OBJECTIVES:
Primary
- Determine the maximum tolerated dose (MTD) of bortezomib during maintenance phase after high-dose melphalan and autologous peripheral blood stem cell transplantation in patients with multiple myeloma.
- Determine the safety and tolerability of bortezomib in these patients.
Secondary
- Determine the overall response rate, complete response rate, and response duration in patients treated with bortezomib at the MTD.
OUTLINE: This is an open-label, dose-finding study.
Patients receive bortezomib IV on days 1, 4, 8, and 11. Treatment repeats every 21 or 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive de-escalating doses of bortezomib (at varying dosing schedules) until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.
After completion of study treatment, patients are followed at 1 year.
PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.
Type d'étude
Inscription (Réel)
Phase
- La phase 1
Contacts et emplacements
Lieux d'étude
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Michigan
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Detroit, Michigan, États-Unis, 48201-1379
- Barbara Ann Karmanos Cancer Institute
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
DISEASE CHARACTERISTICS:
- Diagnosis of multiple myeloma
Must have completed high-dose melphalan and autologous peripheral blood stem cell transplantation
- Transplant must have been completed 30-120 days ago
- Must not be receiving maintenance therapy
- Patients must have received 200 mg/m² of melphalan intravenously as a conditioning regimen (no dose reduction allowed)
- No evidence of amyloidosis
- No available donor
PATIENT CHARACTERISTICS:
- ECOG performance status (PS) 0-2 or Karnofsky PS 60-100%
- Absolute neutrophil count > 1,500/mm^3
- Platelet count > 75,000/mm^3
- Bilirubin ≤ 1.5 times upper limit of normal
- Transaminase ≤ 3 times upper limit of normal
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Must have a negative HIV test
- No baseline neurological disease > grade I
- No cranial nerve palsy
- No demonstrated resistance to bortezomib
- No history of allergic reactions attributed to bortezomib, boron, or mannitol
- No cardiac arrhythmia
- No unstable angina pectoris
- No symptomatic congestive heart failure
- No ongoing or active infection
- No other uncontrolled illness
- No psychiatric illness or social situations that would limit compliance with study requirements
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No other concurrent anticancer therapies or agents
- No other concurrent investigational agents
- Not receiving maintenance therapy after prior stem cell transplantation on another clinical trial
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)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: Bortezomib
Bortezomib is administered as a 5 second IV bolus on days 1, 4, 8,11 or 1,8 and 15 of a 21-35 days cycle (Depending on the Dosing schedule).
The dosage will be calculated based on actual weight of the patient unless the actual weight is greater than 40% above the ideal body weight.
In this instance the dosage will be based on the adjusted ideal body weight.
The Adjusted IBW (kg) = IBW + 0.25 x (actual body weight - IBW).
The dosage will be adjusted based on the safety and toxicity profile, until a MTD is determined.
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Dose of Bortezomib* Level 1: 1.3 mg/m2 on Day 1, 4, 8, 11 - Every 21 days; Level 2: 1.3 mg/m2 on Day 1, 4, 8, 11 - Every 28 days; Level 3: 1.0 mg/m2 on Day 1, 8, 15 - Every 28 days; Level 4: 1.0 mg/m2 on Day 1, 8, 15 - Every 35 days
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
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Maximum tolerated dose
Délai: At course 8
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At course 8
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Safety and tolerability
Délai: At course 8
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At course 8
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
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Overall response rate by Southwest Oncology Group (SWOG) criteria
Délai: At day 30 following stem cell transplant and following course 4, course 8, and 1 year of study treatment
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At day 30 following stem cell transplant and following course 4, course 8, and 1 year of study treatment
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Complete response rate by SWOG criteria
Délai: At day 30 following stem cell transplant and following course 4, course 8, and 1 year of study treatment
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At day 30 following stem cell transplant and following course 4, course 8, and 1 year of study treatment
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Response duration by SWOG criteria
Délai: At day 30 following stem cell transplant and following course 4, course 8, and 1 year of study treatment
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At day 30 following stem cell transplant and following course 4, course 8, and 1 year of study treatment
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chaise d'étude: Muneer H. Abidi, MD, Barbara Ann Karmanos Cancer Institute
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
Mots clés
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
- Agents antinéoplasiques
- Bortézomib
Autres numéros d'identification d'étude
- CDR0000455585
- P30CA022453 (Subvention/contrat des NIH des États-Unis)
- WSU-D-2957
- WSU-0506002467
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 .
Essais cliniques sur bortezomib
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Columbia UniversityInconnueMésothéliomeÉtats-Unis
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Zhongnan HospitalRecrutementLeucémie myéloïde aiguë | BortézomibChine
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Fondazione Italiana Linfomi ONLUSComplétéMacroglobulinémie de WaldenströmItalie
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First Affiliated Hospital, Sun Yat-Sen UniversitySecond Affiliated Hospital of Guangzhou Medical UniversityInconnue
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King Faisal Specialist Hospital & Research CenterComplété