A Randomized, Controlled Phase 3 Study to Evaluate Optimized Retreatment and Prolonged Therapy with Bortezomib (Velcade) in Patients with Multiple Myeloma in First or Second Relapse

Phase 3

Completed

Conditions: Multiple Myeloma
10024324

Registration Number: NL-OMON40386

Lead Sponsor: Janssen-Cilag

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 16

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Disease status and response to therapy will be assessed by investigators based<br /><br>on the IMWG 2011 response criteria.<br /><br><br /><br>Response rates, TTP, DOR, TTNT, ECOG performance status, QoL measures, and MRU<br /><br>data will also be<br /><br>assessed. Overall survival and details of the first alternative multiple<br /><br>myeloma therapy will be evaluated.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Response to therapy will be measured based on changes in the M protein in serum<br /><br>and urine, as determined by SPEP and UPEP. Confirmation by immunofixation and<br /><br>bone marrow assessments will be done in CR.<br /><br>Response and progression will be determined according to the criteria IMWG.<br /><br><br /><br>Duration of response will be measured.<br /><br><br /><br>Time to progression, overall survival, time to new therapy will be measured.<br /><br><br /><br>Difference in ECOG performance status will be determined relative to<br /><br>randomization and compared screening<br /><br><br /><br>Quality of life will be determined on the basis of EORTC QLQ-C30 questionnaire<br /><br>and the EQ-5D questionnaire 5SL.</p><br>