EUCTR2006-007022-64-SE
Active, not recruiting
Not Applicable
Phase II study of bortezomib-dexametason and high-dose melphalan in patients relapsing after high-dose melphalan with autologous stem cell support
DrugsVelcade
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Rigshospitalet
- Enrollment
- 50
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •·First relapse after ASCT
- •·Symptomatic myeloma diagnosis according to international criteria
- •·More than 2,0 x 106 CD34\+ stem cells / kg bodyweight in the freezer for
- •stem cell support
- •·Signed informed consent given prior to any study related activities have
- •been performed
- •·Age \> 18 years
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
Exclusion Criteria
- •·Allogeneic transplantation scheduled as a part of the treatment
- •·Expected survival of less than one month.
- •·Performance status (WHO) \> 3
- •·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
- •·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
Outcomes
Primary Outcomes
Not specified
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