Bortezomib consolidation in patients with myeloma following treatment with high-dose melphalan and autologous stem cell support. A randomised NMSG trial (15/05)
- Conditions
- The main purpose of this trial is to study the effect of consolidation treatment with Velcade after autologous stem cell transplantation (ASCT) for multiple myeloma. At ASCT, patients will be randomised to no consolidation (standard of care) or consolidation with Velcade, 20 doses during 21 weeks, starting 3 months after ASCT. Apart from effect on the disease, quality of life will be studied, as well as health economy.
- Registration Number
- EUCTR2005-002756-18-EE
- Lead Sponsor
- ordic Myeloma Study Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 400
·Symptomatic myeloma diagnosis according to criteria in study protocol 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
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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
·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 & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method