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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT no. 2007-001292-11 |
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The purpose of the study is to compare thalidomide + dexamethasone with bortezomib + dexamethasone in patients with multiple myeloma refractory to melphalan therapy. The main goal is to find out which of these two 2:nd line regimens that offers the patients the best chance for a response with as long duration and as good quality of life as possible.
The study is an open randomized multicentre study in which patients with multiple myeloma refractory to melphalan therapy are randomized between bortezomib and thalidomide therapy, in both arms with the addition of dexamethasone. In case of failure to the initially given treatment the patient will be crossed over to the alternative treatment.
The number of patients needed is calculated to 300, based upon the hypothesis of a 50% difference in progression free survival, a significance level of 95% and a power of 80%. With 12 patients being recruited each month during 25 months and a 4 months follow-up after the last included patient, the total study time will be 29 months.
The dose regimens for bortezomib and thalidomide follow general clinical praxis as regards recommendations for optimal dosing in the Nordic countries.
Evaluation of response and toxicity is performed every 3 weeks for at least 12 weeks, thereafter every 6 weeks. Evaluation of efficacy is done according to The International Myeloma Working Group Uniform Response Criteria. Evaluation of toxicity is done by CTCAE grading. Evaluation of quality of life is done by the EORTC QLQ30 questionnaires with the addition of the myeloma specific MY-24 module which are mailed to the patients at predetermined intervals during the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Bortezomib - dexamethasone |
|
| 2 | Experimental | Thalidomide - dexamethasone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bortezomib | Drug | Bortezomib 1,3 mg/m2 intravenously on days 1, 4, 8 och 11 of every 3 weeks cycle until maximal response, toxicity or maximum 8 cycles Dexamethasone 20 mg days 1-2, 4-5, 8-9 and 11-12 during the first 2 cycles, thereafter individualized dose depending on response and toxicity |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival |
| Measure | Description | Time Frame |
|---|---|---|
| Response rate | ||
| Response duration | ||
| Time to start of other treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martin Hjorth, MD, PhD | Department of Medicine, Lidköping Hospital, S-53185 Lidköping, Sweden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ålborg university Hospital | Aalborg | 9000 | Denmark | |||
| Århus University Hospital |
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|
| Thalidomide | Drug | Thalidomide 50 mg/day with dose escalation every 3 weeks until response or toxicity, maximal dose 200 mg/day Dexamethasone 40 mg/day day 1-4 every 3 weeks for at least 2 courses, thereafter individualized dose depending on response and toxicity |
|
| Toxicity |
| Quality of life |
| Response rate after cross-over |
| Response duration after cross-over |
| Aarhus |
| 8000 |
| Denmark |
| Rigshospitalet | Copenhagen | 2100 | Denmark |
| Herlev University Hospital | Herlev | 2730 | Denmark |
| Odense University Hospital | Odense | 5000 | Denmark |
| Ullevål Sykehus | Oslo | 0407 | Norway |
| Diakonhjemmet | Oslo | Norway |
| Stavanger Universitetssykehus | Stavanger | 4068 | Norway |
| Trondheim University Hospital | Trondheim | N-7006 | Norway |
| Falun Hospital | Falun | 79182 | Sweden |
| Gävle Hospital | Gävle | 80187 | Sweden |
| Sahlgrenska University Hospital | Gothenburg | 41345 | Sweden |
| Helsingborg Hospital | Helsingborg | 25187 | Sweden |
| Lidköping Hospital | Lidköping | 53185 | Sweden |
| Lund University Hospital | Lund | 22185 | Sweden |
| Malmö University Hospital | Malmö | 20502 | Sweden |
| Mölndal hospital | Mölndal | 43180 | Sweden |
| Örebro University Hospital | Örebro | 70185 | Sweden |
| Örnsköldsvik Hospital | Örnsköldsvik | 89189 | Sweden |
| Skövde Hospital | Skövde | 54185 | Sweden |
| St Göran Hospital | Stockholm | 11281 | Sweden |
| Sundsvall Hospital | Sundsvall | 85186 | Sweden |
| Uddevalla Hospital | Uddevalla | 45180 | Sweden |
| Norrland University Hospital | Umeå | 90185 | Sweden |
| Uppsala University Hospital | Uppsala | 75185 | Sweden |
| Växjö Hospital | Vaxjo | 35185 | Sweden |
| Västerås Hospital | Västerås | 72189 | Sweden |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000069286 | Bortezomib |
| D013792 | Thalidomide |
| ID | Term |
|---|---|
| D001897 | Boronic Acids |
| D000148 | Acids, Noncarboxylic |
| D000143 | Acids |
| D007287 | Inorganic Chemicals |
| D001896 | Boron Compounds |
| D009930 | Organic Chemicals |
| D011719 | Pyrazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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