Study to evaluate optimized retreatment and prolonged therapy with bortezomib

• Register: EUCTR
• Last refreshed on: 6 February 2017
• Main ID: EUCTR2011-004795-11-DE
• Date of registration: 21/12/2012
• Prospective Registration: Yes
• Primary sponsor: Janssen-Cilag International N.V.
• Public title: Study to evaluate optimized retreatment and prolonged therapy with bortezomib
• Scientific title: 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: 03/07/2013
• Target sample size: 240
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-004795-11
• Study type: Interventional clinical trial of medicinal product
• Study design: 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: Standard Retreatment Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Belgium, Finland, Germany, Israel, Italy, Netherlands, Poland, Portugal, Sweden, Turkey

Contacts

• Name: Clinical Registry Group
• Affiliation: Janssen-Cilag International N.V.

• Name: Clinical Registry Group
• Affiliation: Janssen-Cilag International N.V.

Key inclusion & exclusion 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 96
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 144

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

Health Condition(s) or Problem(s) studied

Multiple Myeloma
MedDRA version: 17.0 Level: LLT Classification code 10028228 Term: Multiple myeloma System Organ Class: 100000004864

Therapeutic area: Diseases [C] - Cancer [C04]

Intervention(s)

Trade Name: Velcade
Product Name: Bortezomib
Product Code: JNJ-26866138
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: BORTEZOMIB
CAS Number: 179324-69-7
Current Sponsor code: JNJ-26866138
Other descriptive name: Velcade
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 3.5-

Trade Name: Dexamethasone
Product Name: Dexamethason
Pharmaceutical Form: Tablet
CAS Number: 50-02-2
Other descriptive name: DEXAMETHASONE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 4-

Primary Outcome(s)

Main Objective: 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 PFS.

Secondary Objective: - Overall response rate (ORR)
- Time to progression (TTP)
- Duration of response (DOR)
- Time to next myeloma therapy (TTNT)
- Overall Survival (OS)
- Eastern Cooperative Oncology Group (ECOG) Performance Status
- 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])
- Safety

Primary end point(s): Effect of optimized retreatment followed by prolonged therapy versus standard retreatment on Progression Free Survival (PFS)

Timepoint(s) of evaluation of this end point: Folow-up to disease progression or death or to a maximum of 18 months after the last patient is enrolled in the study whichever occurs first.

Secondary Outcome(s)

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: N/A

Secondary ID(s)

2011-004795-11-SE

26866138-MMY-3033

Source(s) of Monetary Support

Janssen Medical Affairs