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

5 mai 2015 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Réel)

34

Phase

  • La phase 1

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Non randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Médicament: vorinostat
Vorinostat capsules. Treatment in 21 day cycles (participants receive vorinostat for 14 days followed by a 7 day break).
Autres noms:
  • Zolinza®
  • MK0683
  • Acide hydroxamique subéroylanilide (SAHA)
Médicament: bortezomib
Bortezomib injection. Given twice weekly for 2 weeks with a 1 week break. Treatment in 21 day cycles.
Autres noms:
  • Velcade
Expérimental: 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.
Médicament: vorinostat
Vorinostat capsules. Treatment in 21 day cycles (participants receive vorinostat for 14 days followed by a 7 day break).
Autres noms:
  • Zolinza®
  • MK0683
  • Acide hydroxamique subéroylanilide (SAHA)
Médicament: bortezomib
Bortezomib injection. Given twice weekly for 2 weeks with a 1 week break. Treatment in 21 day cycles.
Autres noms:
  • Velcade
Expérimental: 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.
Médicament: vorinostat
Vorinostat capsules. Treatment in 21 day cycles (participants receive vorinostat for 14 days followed by a 7 day break).
Autres noms:
  • Zolinza®
  • MK0683
  • Acide hydroxamique subéroylanilide (SAHA)
Médicament: bortezomib
Bortezomib injection. Given twice weekly for 2 weeks with a 1 week break. Treatment in 21 day cycles.
Autres noms:
  • Velcade
Expérimental: 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.
Médicament: vorinostat
Vorinostat capsules. Treatment in 21 day cycles (participants receive vorinostat for 14 days followed by a 7 day break).
Autres noms:
  • Zolinza®
  • MK0683
  • Acide hydroxamique subéroylanilide (SAHA)
Médicament: bortezomib
Bortezomib injection. Given twice weekly for 2 weeks with a 1 week break. Treatment in 21 day cycles.
Autres noms:
  • Velcade
Expérimental: 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.
Médicament: vorinostat
Vorinostat capsules. Treatment in 21 day cycles (participants receive vorinostat for 14 days followed by a 7 day break).
Autres noms:
  • Zolinza®
  • MK0683
  • Acide hydroxamique subéroylanilide (SAHA)
Médicament: bortezomib
Bortezomib injection. Given twice weekly for 2 weeks with a 1 week break. Treatment in 21 day cycles.
Autres noms:
  • Velcade
Expérimental: 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.
Médicament: vorinostat
Vorinostat capsules. Treatment in 21 day cycles (participants receive vorinostat for 14 days followed by a 7 day break).
Autres noms:
  • Zolinza®
  • MK0683
  • Acide hydroxamique subéroylanilide (SAHA)
Médicament: bortezomib
Bortezomib injection. Given twice weekly for 2 weeks with a 1 week break. Treatment in 21 day cycles.
Autres noms:
  • Velcade

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Mean Duration of Treatment With Vorinostat
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Number of Participants With Dose Modifications of Either Vorinostat or Bortezomib Due to Adverse Experiences (AEs) After Treatment With Study Drug
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Merck Sharp & Dohme LLC

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 septembre 2005

Achèvement primaire (Réel)

1 décembre 2009

Achèvement de l'étude (Réel)

1 mai 2011

Dates d'inscription aux études

Première soumission

25 mai 2005

Première soumission répondant aux critères de contrôle qualité

25 mai 2005

Première publication (Estimation)

26 mai 2005

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

21 mai 2015

Dernière mise à jour soumise répondant aux critères de contrôle qualité

5 mai 2015

Dernière vérification

1 mai 2015

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 0683-015
  • 2005_018

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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