Status:
COMPLETED
Efficacy of Bortezomib Consolidation After High-dose Melphalan With Stem Cell Support in Myeloma Patients
Lead Sponsor:
Nordic Myeloma Study Group
Collaborating Sponsors:
Janssen-Cilag Ltd.
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Multiple myeloma is a malignant incurable hematological disease where survival has been significantly improved by high-dose melphalan with autologous stem cell support (ASCT) in younger patients. Howe...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2010
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT00417911
Start Date
December 1 2005
End Date
May 1 2010
Last Update
June 22 2010
Active Locations (20)
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1
Hæmatologisk afdeling B, Aalborg Sygehus Syd
Aalborg, Denmark, DK-9000
2
Hæmatologisk afd. B, Århus Universitetshospital, Amtssygehuset
Århus C, Denmark, DK-8000
3
Hæmatologisk afdeling L Amtssygehuset i Herlev
Herlev, Denmark, DK-2730
4
Medicinsk Hæmatologisk afd L4042, Rigshospitalet
København Ø, Denmark, DK-2100