Study to Evaluate Optimized Retreatment and Prolonged Therapy With Bortezomib
OPTIMRETREAT
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.
3 other identifiers
interventional
80
11 countries
54
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 multiple-myeloma
Started Apr 2013
Shorter than P25 for phase_3 multiple-myeloma
54 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 4, 2013
CompletedStudy Start
First participant enrolled
April 1, 2013
CompletedFirst Posted
Study publicly available on registry
July 30, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2016
CompletedFebruary 17, 2017
February 1, 2017
2.8 years
February 4, 2013
February 16, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Effect of optimized retreatment followed by prolonged therapy versus standard retreatment on Progression Free Survival (PFS)
Time from randomization to therapy to time of diagnosis of PD or death due to any cause
follow 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 Outcomes (8)
Overall Response Rate (ORR)
at end of treatment (defined as a maximum of 6 months in group B and an expected average of 17 months in group A)
Time to Progression (TTP)
at end of treatment (defined as a maximum of 6 months in group B and an expected average of 17 months in group A)
Duration of Response (DOR)
at end of treatment (defined as a maximum of 6 months in group B and an expected average of 17 months in group A)
Time to Next Myeloma Therapy (TTNT)
at end of treatment (defined as a maximum of 6 months in group B and an expected average of 17 months in group A)
Overall Survival (OS)
at end of treatment (defined as a maximum of 6 months in group B and an expected average of 17 months in group A)
- +3 more secondary outcomes
Study Arms (2)
optimized retreatment, prolonged therapy
EXPERIMENTALPatients will start therapy with retreatment with 6 cycles of bortezomib and dexamethasone (two 21-day cycles followed by four 35-day cycles) followed by a second randomization in a 1:1 ratio to 1 of 2 prolonged therapy schedules with bortezomib alone (Group A1: once weekly for the first 4 weeks in 35-day cycles; or Group A2: once every other week)
standard retreatment
OTHERCurrent Standard of Care: Patients will start retreatment with eight 21-day bortezomib and dexamethasone cycles, followed by posttreatment follow-up every 6 weeks.
Interventions
Type= exact number, unit = mg/m2 body surface area, number = 1.3, form = powder for solution for injection, route = subcutaneous, injection on Days 1, 4, 8 and 11, every 21 days of cycle 1 and 2; injection on Days 1, 8, 15, 22, every 35 days for cycles 3 to 6; followed by injections on Days 1, 8, 15, 22 every 35 days (Group A1) or injections every other week (Group A2). Treatment will be stopped at confirmed disease progression
Type= exact number, unit = mg, number = 20, form = tablet, route = oral, intake on Days 1, 2, 4, 5, 8, 9, 11 and 12, every 21 days of cycle 1 and 2; intake on Days 1, 2, 8, 9, 15, 16, 22 and 23 every 35 days for cycles 3 to 6
Type= exact number, unit = mg/m2 body surface area, number = 1.3, form = powder for solution for injection, route = subcutaneous, injection on Days 1,4,8,11, every 21 days for cycles 1 to 8 or until confirmed disease progression
Type = exact number, unit = mg, number = 20, form = tablet, route= oral, intake on Days 1, 2, 4, 5, 8, 9, 11, 12, every 21 days for cycles 1 to 8 or until confirmed disease progression
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (54)
Unknown Facility
Antwerp, Belgium
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Edegem, Belgium
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Haine-Saint-Paul, Belgium
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Hasselt, Belgium
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Sint-Niklaas, Belgium
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Turnhout, Belgium
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Yvoir, Belgium
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Helsinki, Finland
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Lahti, Finland
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Turku, Finland
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Lille, France
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Paris, France
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Périgueux, France
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Rennes, France
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Tours, France
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Cologne, Germany
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Dresden, Germany
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Heidelberg, Germany
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Mutlangen, Germany
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Osnabrück, Germany
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Rostock, Germany
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Haifa, Israel
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Nahariya, Israel
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Ramat Gan, Israel
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Apeldoorn, Netherlands
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Deventer, Netherlands
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Heerlen, Netherlands
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Tilburg, Netherlands
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Zwolle, Netherlands
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Fredrikstad, Norway
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Stavanger, Norway
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Trondheim, Norway
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Brzozów, Poland
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Chorzów, Poland
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Lodz, Poland
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Lublin, Poland
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Olsztyn, Poland
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Opole, Poland
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Słupsk, Poland
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Wroclaw, Poland
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Coimbra, Portugal
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Ponta Delgada, Portugal
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Porto, Portugal
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Borås, Sweden
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Falun, Sweden
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Huddinge, Sweden
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Stockholm, Sweden
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Adana, Turkey (Türkiye)
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Ankara, Turkey (Türkiye)
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Bursa, Turkey (Türkiye)
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Istanbul, Turkey (Türkiye)
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Izmir, Turkey (Türkiye)
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Samsun, Turkey (Türkiye)
Unknown Facility
Trabzon, Turkey (Türkiye)
Related Publications (1)
Terpos E, Gobbi M, Potamianou A, Lahaye M, Couturier C, Cavo M. Retreatment and prolonged therapy with subcutaneous bortezomib in patients with relapsed multiple myeloma: A randomized, controlled, phase III study. Eur J Haematol. 2018 Jan;100(1):10-19. doi: 10.1111/ejh.12937. Epub 2017 Oct 30.
PMID: 28801967DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 4, 2013
First Posted
July 30, 2013
Study Start
April 1, 2013
Primary Completion
February 1, 2016
Study Completion
February 1, 2016
Last Updated
February 17, 2017
Record last verified: 2017-02