- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00417911
Efficacy of Bortezomib Consolidation After High-dose Melphalan With Stem Cell Support in Myeloma Patients
Clinical Protocol Bortezomib Consolidation in Patients With Myeloma Following Treatment With High-dose Melphalan and Autologous Stem Cell Support. A Randomised NMSG Trial (15/05)
Study Overview
Detailed Description
Rationale:
ASCT prolongs EFS and OS for myeloma patients < 65 years of age. During the period from ASCT to progression most myeloma patients experience few symptoms and have a good quality of life11. A further prolongation of EFS would be a big step forward in myeloma treatment. Bortezomib is a new promising agent, which has shown clear anti-myeloma effect in heavily pre-treated patients. After ASCT the tumour cell burden is low and it is the hypothesis of this clinical trial that the unique mechanism of action of bortezomib may reduce the number of tumour cells even further and by doing so prolong EFS.
Primary objective:
* Evaluate the effect on EFS (an event is defined as either progression or death of any cause without preceding progression) of consolidation treatment with bortezomib after ASCT compared to no consolidation
Secondary objectives:
- Overall survival from ASCT
- Overall survival from start of relapse treatment
- Time to need for relapse treatment
- Response rate in patients not in CR following ASCT
- Toxicity from consolidation treatment
- Quality of life
- Cost utility
- Planned subgroup analysis: comparison of primary and secondary endpoint in patients receiving one vs. two high dose treatments
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Herlev, Denmark, DK-2730
- Hæmatologisk afdeling L Amtssygehuset i Herlev
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København Ø, Denmark, DK-2100
- Medicinsk Hæmatologisk afd L4042, Rigshospitalet
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Odense C, Denmark, DK-5000
- Hæmatologisk afd X, Odense Universitetshospital
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Ålborg, Denmark, DK-9000
- Hæmatologisk afdeling B, Aalborg Sygehus Syd
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Århus C, Denmark, DK-8000
- Hæmatologisk afd. B, Århus Universitetshospital, Amtssygehuset
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Tampere, Finland, SF-33 521
- Tampere University Hospital, Dep 10a
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Turku, Finland, SF-20521
- Turku University Hospital, Dept. of Medicine, PL 52,
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Reykjavik, Iceland, 101
- Hemathology department, University State Hospital, Landspitali
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Bergen, Norway, N-5021
- Hematologisk seksjon, med avd, Haukeland Universitetssykehus
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Oslo, Norway, N - 0407
- Hematologisk avdeling Ullevål Sykehus
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Oslo, Norway, N - 0027
- Seksjon for blodsykdommer, Med. avd.,Rikshospitalet
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Tromsø, Norway, N-9038
- Med avd B, Hematologisk seksjon, Universitetssykehuset Nord Norge
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Trondheim, Norway, N - 7006
- Hematologisk seksjon Regionssykehuset
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Huddinge, Sweden, SE-141 86
- Hematologiska klin, Huddinge sjukhus
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Linköping, Sweden, SE-581 85
- Hematologkliniken, Universitetssjukhuset
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Lund, Sweden, SE-221 85
- University Hospital Lund
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Malmö, Sweden, SE-205 02
- Medicinklin, Universitetssjukhuset MAS,
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Umeå, Sweden, SE-901 85
- Medicinklin, sekt för hematologi, Norrlands Universitetssjukhus
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Uppsala, Sweden, SE-751 85
- Medicinklin, Akademiska sjukhuset
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Örebro, Sweden, SE-70185
- Medicinkliniken, Universitetssjukhuset
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Symptomatic myeloma diagnosis according to criteria in attachment 3
- ASCT is performed or has been performed in the last five weeks (time limit two weeks for patients randomised at 2nd transplantation) as a part of primary therapy
- Signed informed consent given prior to any study related activities have been performed
Exclusion Criteria:
- Prior exposure to bortezomib
- Allogeneic transplantation scheduled as a part of the primary treatment
- Neuropathy > Grade 2 (neurological symptoms interfering with ADL)
- Non-secreting myeloma
- Other concurrent disease making bortezomib treatment unsuitable
- Positive pregnancy test (only applicable for women with childbearing potential)
- Has known or suspected hypersensitivity or intolerance to boron, mannitol, or heparin, if an indwelling catheter is used
- Uncontrolled or severe cardiovascular disease including myocardial infarction within 6 months of enrolment, New York Heart Association (NYHA) Class III or IV heart failure (Attachment 6, NYHA Classification of Cardiac Disease), uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis
- History of hypotension or has decreased blood pressure (sitting systolic blood pressure [SBP] £100 mmHg and/or sitting diastolic blood pressure [DBP] £60 mmHg)
- Serious medical or psychiatric illness likely to interfere with participation in this clinical study
- Have received an experimental drug or used an experimental medical device within 4 weeks prior to inclusion into the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: No treatment
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Bortezomib 1,3 mg/sqm Days 1,4,8,11 for two 3-week cycles and then once a week for three weeks in 4 4-week cycles
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Experimental: Bortezomib consolidation
Bortezomib consolidation : 20 injections starting 3 months after ASCT
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Bortezomib 1,3 mg/sqm Days 1,4,8,11 for two 3-week cycles and then once a week for three weeks in 4 4-week cycles
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Evaluate the effect on EFS (an event is defined as either progression or death of any cause without preceding progression) of consolidation treatment with bortezomib after ASCT compared to no consolidation
Time Frame: 1 year after randomization of the last patient
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1 year after randomization of the last patient
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Secondary Outcome Measures
Outcome Measure |
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Quality of life
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Cost utility
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Overall survival from ASCT
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Overall survival from start of relapse treatment
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Time to need for relapse treatment
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Response rate in patients not in CR following ASCT
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Toxicity from consolidation treatment
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Planned subgroup analysis: comparison of primary and secondary endpoint in patients receiving one vs. two high dose treatments
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ulf-Henrik Mellqvist, Dr., PhD, NMSG
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Hematologic Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Antineoplastic Agents
- Bortezomib
Other Study ID Numbers
- NMSG 15/05
- EudraCT No: 2005-002756-18
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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