Multiple Myeloma MedDRA version: 17.0 Level: LLT Classification code 10028228 Term: Multiple myeloma System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Velcade
Product Name: Bortezomib
Product Code: JNJ-26866138
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: BORTEZOMIB
CAS Number: 179324-69-7
Current Sponsor c
Sponsors
Janssen-Cilag International N.V.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Have received a bortezomib containing regimen in one of the previous line(s) of therapy and have shown at least PR to the previous bortezomib therapy. Have relapsed / progressed multiple myeloma following 1 or 2 previous lines of therapy as defined in the protocol. Have measurable secretory multiple myeloma: measurable disease for secretory multiple myeloma is defined by at least one of the following measurements: serum M protein greater than or equal to 1 g/dL (=10g/L], urine M-protein of =200 mg/24 hours. Have an ECOG performance status of =2. Have a life expectancy estimated at screening of =6 months. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 96 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 144
Exclusion criteria
Exclusion criteria: Has received more than 2 previous lines of therapy for multiple myeloma or has received no previous bortezomib-containing regimen. Has been refractory to bortezomib, defined as either having progressed during bortezomib therapy or relapsed/progressed within 6 months after the last dose of bortezomib. Has oligosecretory or nonsecretory multiple myeloma. Has a history of a myocardial infarction within 6 months of enrollment or has New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Has peripheral neuropathy or neuropathic pain of grade 2 or greater intensity, as defined by the National Cancer Institute Common Terminology Criteria of Adverse Events (NCI CTCAE), version 4.0.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this study is to describe the effect of optimized retreatment with bortezomib in combination with dexamethasone followed by prolonged therapy with bortezomib, versus standard retreatment with bortezomib in combination with dexamethasone on PFS.;Primary end point(s): Effect of optimized retreatment followed by prolonged therapy versus standard retreatment on Progression Free Survival (PFS);Timepoint(s) of evaluation of this end point: Follow-up to disease progression or death or to a maximum of 18 monthsafter the last patient is enrolled in the study whichever occurs first.;Secondary Objective: - Overall response rate (ORR) - Time to progression (TTP) - Duration of response (DOR) - Time to next myeloma therapy (TTNT) - Overall Survival (OS) - Eastern Cooperative Oncology Group (ECOG) Performance Status - Quality of life (QoL: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire–C30 [EORTC QLQ-C30] and European Quality of Life-5 Dimensions Questionnaire [EQ-5D]) - Safety | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - ORR - TTP - DOR - TTNT - OS - Changes in ECOG performance status from baseline, and QoL;Timepoint(s) of evaluation of this end point: Follow-up to end of study or to a maximum of 18 months after the last patient enrolled in the study whichever occurs first. | — |
Countries
Belgium, Finland, Germany, Israel, Italy, Netherlands, Poland, Portugal, Sweden, Turkey
Contacts
Public ContactClinical Registry Group
Janssen-Cilag International N.V.
Outcome results
None listed