Overview

Study to Evaluate Optimized Retreatment and Prolonged Therapy With Bortezomib

Status:
Completed
Trial end date:
2016-02-01
Target enrollment:
0
Participant gender:
All
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 retreatment with bortezomib in combination with dexamethasone on progression free survival (PFS).
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Janssen-Cilag International NV
Treatments:
BB 1101
Bortezomib
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
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.

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.