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Phase 1 Study of Vorinostat and Bortezomib in Multiple Myeloma (MK-0683-015 EXT 1 (AM1))

5 maggio 2015 aggiornato da: Merck Sharp & Dohme LLC

Phase I Clinical Trial of Vorinostat (MK-0683) in Combination With Bortezomib in Patients With Advanced Multiple Myeloma

The purposes of this study are:

  • To determine the maximum tolerated dose (MTD) for the combination of oral vorinostat and bortezomib in participants with advanced multiple myeloma
  • To assess the safety and tolerability of this regimen and to document the participant's clinical status (by anti-tumor activity) for this combination, as determined per standard of care.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

34

Fase

  • Fase 1

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • Adults with refractory or relapsed multiple myeloma
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 (a measurement to determine participant's ability to perform daily activities)
  • Adequate bone marrow reserve
  • Adequate hepatic and renal function
  • Ability to swallow capsules
  • 3 weeks or more since prior chemotherapy and have recovered from prior toxicities

Exclusion Criteria:

  • Participants who plan to have a bone marrow transplant within 4 weeks of start of treatment
  • Participants with prior treatment with other investigational agents with a similar anti-tumor mechanism
  • Participants with other active/uncontrolled clinically significant illness
  • Pregnant or nursing female participants
  • Participants who received bortezomib within 3 months of start of this trial

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Non randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: vorinostat 200 mg + bortezomib 0.7 mg/m^2
Vorinostat capsules given twice daily (b.i.d.); bortezomib injection given on Days 4, 8, 11, and 15 of each cycle.
Droga: vorinostat
Vorinostat capsules. Treatment in 21 day cycles (participants receive vorinostat for 14 days followed by a 7 day break).
Altri nomi:
  • Zolinza®
  • MK0683
  • Suberoilanilide acido idrossamico (SAHA)
Droga: bortezomib
Bortezomib injection. Given twice weekly for 2 weeks with a 1 week break. Treatment in 21 day cycles.
Altri nomi:
  • Velcade
Sperimentale: vorinostat 200 mg + bortezomib 0.9 mg/m^2
Vorinostat capsules given b.i.d.; bortezomib injection given on Days 4, 8, 11, and 15 of each cycle.
Droga: vorinostat
Vorinostat capsules. Treatment in 21 day cycles (participants receive vorinostat for 14 days followed by a 7 day break).
Altri nomi:
  • Zolinza®
  • MK0683
  • Suberoilanilide acido idrossamico (SAHA)
Droga: bortezomib
Bortezomib injection. Given twice weekly for 2 weeks with a 1 week break. Treatment in 21 day cycles.
Altri nomi:
  • Velcade
Sperimentale: vorinostat 300 mg + bortezomib 1.3 mg/m^2
Vorinostat given once daily (q.d.); bortezomib given on Days 1, 4, 8, and 11 of each cycle.
Droga: vorinostat
Vorinostat capsules. Treatment in 21 day cycles (participants receive vorinostat for 14 days followed by a 7 day break).
Altri nomi:
  • Zolinza®
  • MK0683
  • Suberoilanilide acido idrossamico (SAHA)
Droga: bortezomib
Bortezomib injection. Given twice weekly for 2 weeks with a 1 week break. Treatment in 21 day cycles.
Altri nomi:
  • Velcade
Sperimentale: vorinostat 400 mg + bortezomib 0.9 mg/m^2
Vorinostat given q.d.; bortezomib given on Days 1, 4, 8, and 11 of each cycle.
Droga: vorinostat
Vorinostat capsules. Treatment in 21 day cycles (participants receive vorinostat for 14 days followed by a 7 day break).
Altri nomi:
  • Zolinza®
  • MK0683
  • Suberoilanilide acido idrossamico (SAHA)
Droga: bortezomib
Bortezomib injection. Given twice weekly for 2 weeks with a 1 week break. Treatment in 21 day cycles.
Altri nomi:
  • Velcade
Sperimentale: vorinostat 400 mg + bortezomib 1.1 mg/m^2
Vorinostat given q.d.; bortezomib given on Days 1, 4, 8, and 11 of each cycle.
Droga: vorinostat
Vorinostat capsules. Treatment in 21 day cycles (participants receive vorinostat for 14 days followed by a 7 day break).
Altri nomi:
  • Zolinza®
  • MK0683
  • Suberoilanilide acido idrossamico (SAHA)
Droga: bortezomib
Bortezomib injection. Given twice weekly for 2 weeks with a 1 week break. Treatment in 21 day cycles.
Altri nomi:
  • Velcade
Sperimentale: vorinostat 400 mg + bortezomib 1.3 mg/m^2
Vorinostat given q.d.; bortezomib given on Days 1, 4, 8, and 11 of each cycle.
Droga: vorinostat
Vorinostat capsules. Treatment in 21 day cycles (participants receive vorinostat for 14 days followed by a 7 day break).
Altri nomi:
  • Zolinza®
  • MK0683
  • Suberoilanilide acido idrossamico (SAHA)
Droga: bortezomib
Bortezomib injection. Given twice weekly for 2 weeks with a 1 week break. Treatment in 21 day cycles.
Altri nomi:
  • Velcade

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Mean Duration of Treatment With Vorinostat
Lasso di tempo: Day 1 to an event causing discontinuation from the study, assessed up to 29 months

Event causing discontinuation from the study was defined as (1) progressive disease OR (2) intolerable toxicity.

Progressive disease was defined as:

  • >25% increase in the level of serum monoclonal paraprotein.
  • 25% increase in 24-hour urinary light chain excretion.
  • >25% increase in plasma cells in a bone marrow aspirate or on trephine

biopsy.

  • Development of new bone lesions or soft tissue plasmacytomas.
  • Development of hypercalcemia.

Intolerable toxicity was based on the clinical judgment of the investigator.
Day 1 to an event causing discontinuation from the study, assessed up to 29 months

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of Participants With Dose Modifications of Either Vorinostat or Bortezomib Due to Adverse Experiences (AEs) After Treatment With Study Drug
Lasso di tempo: Day 1 to disease progression, toxicity, or death, assessed up to 29 months
An adverse experience (AE) was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the sponsor's product, was also an adverse experience.
Day 1 to disease progression, toxicity, or death, assessed up to 29 months
Mean Time to First AE Resulting in a Dose Modification in Either Vorinostat or Bortezomib
Lasso di tempo: Day 1 to disease progression, toxicity, or death, assessed up to 29 months
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the sponsor's product, was also an adverse experience.
Day 1 to disease progression, toxicity, or death, assessed up to 29 months
Clinical AE Summary
Lasso di tempo: Day 1 up to disease progression, toxicity, or death, assessed up to 30 days after end of treatment (up to 30 months)

An AE was defined as any unfavorable/unintended change in the structure/function/chemistry of the body temporally associated with the use of study drug, or any worsening of a preexisting condition.

A serious AE (SAE) was any AE that resulted in death, was life threatening, resulted in a persistent or significant disability/incapacity, resulted in or prolonged an existing inpatient hospitalization, was a congenital anomaly/birth defect, was a new cancer, or was an overdose.
Day 1 up to disease progression, toxicity, or death, assessed up to 30 days after end of treatment (up to 30 months)
Laboratory AE Summary
Lasso di tempo: Day 1 up to disease progression, toxicity, or death, assessed up to 29 months

An AE was defined as any unfavorable/unintended change in the structure/function/chemistry of the body temporally associated with the use of study drug, or any worsening of a preexisting condition.

A SAE was any AE that resulted in death, was life threatening, resulted in a persistent or significant disability/incapacity, resulted in or prolonged an existing inpatient hospitalization, was a congenital anomaly/birth defect, was a new cancer, or was an overdose.

A lab (S)AE was any lab value considered clinically significant in the investigator's judgment.
Day 1 up to disease progression, toxicity, or death, assessed up to 29 months

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Merck Sharp & Dohme LLC

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 settembre 2005

Completamento primario (Effettivo)

1 dicembre 2009

Completamento dello studio (Effettivo)

1 maggio 2011

Date di iscrizione allo studio

Primo inviato

25 maggio 2005

Primo inviato che soddisfa i criteri di controllo qualità

25 maggio 2005

Primo Inserito (Stima)

26 maggio 2005

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

21 maggio 2015

Ultimo aggiornamento inviato che soddisfa i criteri QC

5 maggio 2015

Ultimo verificato

1 maggio 2015

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 0683-015
  • 2005_018

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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