Carfilzomib, Pomalidomide, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma

Titre officiel

Multicentre, Open-label, Single-arm, Phase 1b/2 Study of the Safety and Efficacy of Combination Treatment With Pomalidomide, Dexamethasone, and Carfilzomib (PdC) in Subjects With Relapsed and Relapsed/Refractory Multiple Myeloma

Sommaire:

The study will investigate the effects of adding carfilzomib to the combination of pomalidomide and dexamethasone in sequential dose escalation cohorts in patients with relapsed or refractory multiple myeloma. This portion of the study is complete. This study will also investigate the effects of adding daratumumab to the combination of carfilzomib, pomalidomide and dexamethasone.

Description de l'essai

Primary Outcome:

  • Maximum tolerated dose (MTD) of carfilzomib when administered in combination with pomalidomide and dexamethasone
  • Partial response rate after 4 courses according to International Myeloma Working Group (IMWG) criteria
  • Response rates of carfilzomib, pomalidomide, dexamethasone, and daratumumab dosing according to International Myeloma Working Group (IMWG) criteria
Secondary Outcome:
  • Overall response rate
  • Time to progression
  • Duration of response
  • Progression-free survival
  • Overall survival
Patients receive carfilzomib, pomalidomide, and dexamethasone in 28 days treatment cycles. Study treatment continues for as long a their myeloma does not worsen and they do not have unacceptable side effects. After completion of study treatment, patients are followed for up to 2 years.

Voir cet essai sur ClinicalTrials.gov

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