Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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11 April 2016 |
Main ID: |
EUCTR2011-004795-11-IT |
Date of registration:
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14/01/2013 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Study to evaluate optimized retreatment and prolonged therapy with bortezomib
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Scientific title:
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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 - OPTIMIZED-RETREAT |
Date of first enrolment:
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10/02/2013 |
Target sample size:
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240 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-004795-11 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes
Randomised: yes
Open: yes
Single blind: no
Double blind: no
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: yes
Other specify the comparator: Observational arm
Number of treatment arms in the trial: 2
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Phase:
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Countries of recruitment
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Belgium
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Finland
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Germany
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Israel
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Italy
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Netherlands
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Poland
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Portugal
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Sweden
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Turkey
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Contacts
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Name:
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Clinical Registry Group
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Address:
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Archimedesweg 29
2333CM
Leiden
Netherlands |
Telephone:
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+31 (0) 71 524 21 66 |
Email:
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ClinicalTrialsEU@its.jnj.com |
Affiliation:
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Janssen-Cilag International NV |
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Name:
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Clinical Registry Group
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Address:
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Archimedesweg 29
2333CM
Leiden
Netherlands |
Telephone:
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+31 (0) 71 524 21 66 |
Email:
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ClinicalTrialsEU@its.jnj.com |
Affiliation:
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Janssen-Cilag International NV |
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Key inclusion & exclusion criteria
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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.
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Therapeutic area: Diseases [C] - Cancer [C04]
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Multiple Myeloma MedDRA version: 15.1
Level: PT
Classification code 10028228
Term: Multiple myeloma
System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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Intervention(s)
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Trade Name: VELCADE*EV SC 1FL 3,5MG 10ML Pharmaceutical Form: Powder for solution for injection INN or Proposed INN: BORTEZOMIB CAS Number: 179324-69-7 Current Sponsor code: JNJ-26866138 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 3.5-
Trade Name: Dexamethason JENAPHARM Pharmaceutical Form: Tablet INN or Proposed INN: DEXAMETHASONE CAS Number: 50-02-2 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 4-
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Primary Outcome(s)
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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
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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
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Timepoint(s) of evaluation of this end point: Once 186 events occured
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Primary end point(s): PFS
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Secondary Outcome(s)
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Timepoint(s) of evaluation of this end point: NA
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Secondary end point(s): - ORR - TTP - DOR - TTNT - OS - Changes in ECOG performance status from baseline, and QoL
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Secondary ID(s)
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2011-004795-11-SE
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26866138-MMY-3033
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Source(s) of Monetary Support
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JANSSEN-CILAG SpA
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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