Status:
COMPLETED
Study to Evaluate Optimized Retreatment and Prolonged Therapy With Bortezomib
Lead Sponsor:
Janssen-Cilag International NV
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 retreatm...
Detailed Description
This is an interventional, randomized (assignment to a group is happening by chance, like flipping a coin), open-label, parallel-group, event-driven, international, multicenter, Phase 3 study. This st...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2016
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT01910987
Start Date
April 1 2013
End Date
February 1 2016
Last Update
February 17 2017
Active Locations (54)
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1
Antwerp, Belgium
2
Edegem, Belgium
3
Haine-Saint-Paul, Belgium
4
Hasselt, Belgium