- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Fase 1
Kontakter og plasseringer
Studiesteder
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Michigan
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Detroit, Michigan, Forente stater, 48201-1379
- Barbara Ann Karmanos Cancer Institute
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: 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
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
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Maximum tolerated dose
Tidsramme: At course 8
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At course 8
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Safety and tolerability
Tidsramme: At course 8
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At course 8
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Sekundære resultatmål
Resultatmål |
Tidsramme |
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Overall response rate by Southwest Oncology Group (SWOG) criteria
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Studiestol: Muneer H. Abidi, MD, Barbara Ann Karmanos Cancer Institute
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Kardiovaskulære sykdommer
- Vaskulære sykdommer
- Sykdommer i immunsystemet
- Neoplasmer etter histologisk type
- Neoplasmer
- Lymfoproliferative lidelser
- Immunproliferative lidelser
- Hematologiske sykdommer
- Hemoragiske lidelser
- Hemostatiske lidelser
- Paraproteinemier
- Blodproteinforstyrrelser
- Multippelt myelom
- Neoplasmer, plasmacelle
- Plasmacytom
- Antineoplastiske midler
- Bortezomib
Andre studie-ID-numre
- CDR0000455585
- P30CA022453 (U.S. NIH-stipend/kontrakt)
- WSU-D-2957
- WSU-0506002467
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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