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Bortezomib in Treating Patients With Multiple Myeloma Who Have Undergone an Autologous Peripheral Blood Stem Cell Transplant

18. november 2013 opdateret af: Muneer Abidi, Barbara Ann Karmanos Cancer Institute

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.

Studieoversigt

Status

Afsluttet

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

15

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Michigan
      • Detroit, Michigan, Forenede Stater, 48201-1379
        • Barbara Ann Karmanos Cancer Institute

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
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 navne:
  • Velcade®

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Maximum tolerated dose
Tidsramme: At course 8
At course 8
Safety and tolerability
Tidsramme: At course 8
At course 8

Sekundære resultatmål

Resultatmål
Tidsramme
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
At day 30 following stem cell transplant and following course 4, course 8, and 1 year of study treatment
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
At day 30 following stem cell transplant and following course 4, course 8, and 1 year of study treatment
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
At day 30 following stem cell transplant and following course 4, course 8, and 1 year of study treatment

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Samarbejdspartnere

Efterforskere

  • Studiestol: Muneer H. Abidi, MD, Barbara Ann Karmanos Cancer Institute

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juli 2005

Primær færdiggørelse (Faktiske)

1. november 2010

Studieafslutning (Faktiske)

1. juni 2012

Datoer for studieregistrering

Først indsendt

6. februar 2006

Først indsendt, der opfyldte QC-kriterier

6. februar 2006

Først opslået (Skøn)

7. februar 2006

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

19. november 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. november 2013

Sidst verificeret

1. november 2013

Mere information

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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