Study to evaluate optimized retreatment and prolonged therapy with bortezomib

Conditions: Multiple Myeloma
MedDRA version: 15.1Level: PTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2011-004795-11-IT

Lead Sponsor: JANSSEN-CILAG INTERNATIONAL N.V.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 240

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. Have a life expectancy estimated at screening of =6 months.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 9
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 9

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 clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The objective of this study is to explore 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;Secondary Objective: 1)Overall response rate (ORR).2)Time to progression (TTP).3)Duration of response (DOR).4)Time to next myeloma therapy (TTNT).5)Overall Survival (OS).6)Eastern Cooperative Oncology Group (ECOG) Performance Status .7)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]).8)Safety;Primary end point(s): PFS;Timepoint(s) of evaluation of this end point: Once 186 events occured

Secondary Outcome Measures

Name	Time	Method
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: NA