E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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. |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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 |
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E.2.2 | Secondary objectives of the trial |
· 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
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal 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
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E.4 | Principal 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
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E.5 End points |
E.5.1 | Primary end point(s) |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | Yes |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Standard of care - no tretament |
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E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 4 |