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.
Conditions
Interventions
Product Name: Velcade
Pharmaceutical Form: Powder for suspension for injection
Sponsors
Nordic Myeloma Study Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ·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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main 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;Primary end point(s): Event free survival;Secondary Objective: · 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 | — |
Countries
Estonia, Finland, Iceland, Sweden
Outcome results
None listed