Description:

A Study of JNJ-54767414 (Daratumumab) in Combination With Bortezomib and Dexamethasone (D-Vd) in Japanese Participants With Relapsed or Refractory Multiple Myeloma; ODM derived from: https://clinicaltrials.gov/show/NCT02497378

Link:

https://clinicaltrials.gov/show/NCT02497378

Keywords:
Versions (1) ▾
  1. 5/15/19
Copyright Holder:
See clinicaltrials.gov
Uploaded on:

May 15, 2019

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License:
Creative Commons BY 4.0
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Eligibility Multiple Myeloma NCT02497378

Eligibility Multiple Myeloma NCT02497378

Inclusion Criteria
participants proven to have symptomatic (having symptoms) multiple myeloma (mm) according the international myeloma working group (imwg) diagnostic criteria
participant must have documented mm as defined by following criteria: monoclonal plasma cells in the bone marrow 10 percent (%), or presence of a biopsy-proven plasmacytoma at some point in their disease history, disease measurements: a) serum m-protein greater than or equal to (>=) 1 gram per deciliter (g/dl) (>=10 gram per liter [g/l]) b) serum immunoglobulin a [iga] m-protein >= 0.5 g/dl); c) urine m-protein >=200 milligram per 24 hour (mg/24 h); d) serum immunoglobulin free light chain >=10 mg/dl and abnormal serum immunoglobulin kappa lambda free light chain ratio
participant must have received at least 1 prior line of therapy for mm
participant must have an eastern cooperative oncology group (ecog) performance status score of 0 or 1
participant must have achieved a response (partial response [pr] or better based on investigator's determination of response by the imwg criteria) to at least 1 prior regimen
Exclusion Criteria
participant has received daratumumab or other anti-cluster of differentiation 38 (anti-cd38) therapies previously
is refractory to bortezomib or another pi, like ixazomib and carfilzomib (had progression of disease while receiving bortezomib therapy or within 60 days of ending bortezomib therapy or another pi therapy, like ixazomib and carfilzomib
is intolerant to bortezomib (ie, discontinued due to any adverse event while on bortezomib treatment)
has received anti-myeloma treatment within 2 weeks or 5 pharmacokinetic half-lives of the treatment, whichever is longer, before the date of daratumumab first administration. the only exception is emergency use of a short course of corticosteroids (equivalent of dexamethasone 40 milligram per day [mg/day] for a maximum of 4 days) before treatment. a list of anti-myeloma treatments with the corresponding pharmacokinetic half-lives is provided in the site investigational product procedures manual (ippm)
has a history of malignancy (other than multiple myeloma) within 3 years before the date of daratumumab first administration
has any concurrent medical condition or disease (eg, active systemic infection, pulmonary impairment) that is likely to interfere with study procedures