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| Sponsored by: |
Nordic Myeloma Study Group |
|---|---|
| Information provided by: | Nordic Myeloma Study Group |
| ClinicalTrials.gov Identifier: | NCT00602511 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Myeloma |
Drug: Bortezomib Drug: Thalidomide |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Crossover Assignment, Efficacy Study |
| Official Title: | Thalidomide Versus Bortezomib in Melphalan Refractory Myeloma |
| Estimated Enrollment: | 300 |
| Study Start Date: | October 2007 |
| Estimated Study Completion Date: | May 2010 |
| Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Active Comparator
Bortezomib - dexamethasone
|
Drug: Bortezomib
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 |
|
2: Experimental
Thalidomide - dexamethasone
|
Drug: Thalidomide
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 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Martin Hjorth, MD, PhD | +46 510 85000 | martin.hjorth@vgregion.se |
| Contact: Lene Meldgaard Knudsen, MD, PhD | +45 65411157 | l.meldgaard@dadlnet.dk |
| Denmark | |
| Odense University Hospital | Not yet recruiting |
| Odense, Denmark, 5000 | |
| Principal Investigator: Per Per, MD | |
| Rigshospitalet | Not yet recruiting |
| Koebenhavn, Denmark, 2100 | |
| Principal Investigator: Peter Gimsing, MD, PhD | |
| Herlev University Hospital | Not yet recruiting |
| Herlev, Denmark, 2730 | |
| Principal Investigator: Annette Vangsted, MD, PhD | |
| Viborg Hospital | Not yet recruiting |
| Viborg, Denmark | |
| Principal Investigator: Bjarne Bach, MD | |
| Ålborg university Hospital | Not yet recruiting |
| Aalborg, Denmark, 9000 | |
| Principal Investigator: Henrik Gregersen, MD | |
| Århus University Hospital | Not yet recruiting |
| Århus, Denmark, 8000 | |
| Principal Investigator: Nils Frost Andersen, MD | |
| Esbjerg Hospital | Not yet recruiting |
| Esbjerg, Denmark, 67000 | |
| Principal Investigator: Bruno Bengtson, MD | |
| Vejle Hospital | Not yet recruiting |
| Vejle, Denmark, 7100 | |
| Principal Investigator: Torben Plesner, MD, PhD | |
| Norway | |
| Trondheim University Hospital | Not yet recruiting |
| Trondheim, Norway, N-7006 | |
| Principal Investigator: Öyvind Hjertner, MD, PhD | |
| Ullevål Sykehus | Not yet recruiting |
| Oslo, Norway, 0407 | |
| Principal Investigator: Nina Gulbrandsen, MD, PhD | |
| Stavanger Universitetssykehus | Not yet recruiting |
| Stavanger, Norway, 4068 | |
| Principal Investigator: Einar Haukås, MD | |
| Universitetssykehuset i Nord-Norge | Not yet recruiting |
| Tromsø, Norway, 9038 | |
| Principal Investigator: Inger Marie Dahl, MD, PhD | |
| Sweden | |
| Sahlgrenska University Hospital | Recruiting |
| Göteborg, Sweden, 41345 | |
| Principal Investigator: Ulf-Henrik Mellqvist, MD, PhD | |
| Lidköping Hospital | Recruiting |
| Lidköping, Sweden, 53185 | |
| Principal Investigator: Sven Erdal, MD | |
| Uddevalla Hospital | Recruiting |
| Uddevalla, Sweden, 45180 | |
| Principal Investigator: Björn Andréasson, MD, PhD | |
| Skövde Hospital | Recruiting |
| Skövde, Sweden, 54185 | |
| Principal Investigator: Rolf Billström, MD, PhD | |
| Mölndal hospital | Recruiting |
| Mölndal, Sweden, 43180 | |
| Principal Investigator: Rose-Marie Kristoffersen, MD | |
| Örnsköldsvik Hospital | Not yet recruiting |
| Örnsköldsvik, Sweden, 89189 | |
| Principal Investigator: Kjell Lundkvist, MD | |
| Malmö University Hospital | Not yet recruiting |
| Malmö, Sweden, 20502 | |
| Principal Investigator: Elena Holm, MD | |
| Växjö Hospital | Recruiting |
| Växjö, Sweden, 35185 | |
| Principal Investigator: Margaretha S Carlsson, MD | |
| Halmstad Hospital | Not yet recruiting |
| Halmstad, Sweden, 30185 | |
| Principal Investigator: Conny Carlsson, MD | |
| Helsingborg Hospital | Not yet recruiting |
| Helsingborg, Sweden, 25187 | |
| Principal Investigator: Per Axelsson, MD | |
| Linköping University Hospital | Not yet recruiting |
| Linköping, Sweden, 58185 | |
| Principal Investigator: Lucia Ahlberg, MD | |
| Karolinska University Hospital, Solna | Not yet recruiting |
| Stockholm, Sweden, 17176 | |
| Principal Investigator: Astrid Gruber, MD, PhD | |
| St Göran Hospital | Not yet recruiting |
| Stockholm, Sweden, 11281 | |
| Principal Investigator: Torbjörn Karlsson, MD | |
| Stockholm South General Hospital | Not yet recruiting |
| Stockholm, Sweden, 11883 | |
| Principal Investigator: Jan Samuelsson, MD, PhD | |
| Uppsala University Hospital | Not yet recruiting |
| Uppsala, Sweden, 75185 | |
| Principal Investigator: Kristina Carlson, MD, PhD | |
| Örebro University Hospital | Recruiting |
| Örebro, Sweden, 70185 | |
| Principal Investigator: Olle Linder, MD | |
| Västerås Hospital | Recruiting |
| Västerås, Sweden, 72189 | |
| Principal Investigator: Torbjörn Karlsson, MD | |
| Falun Hospital | Not yet recruiting |
| falun, Sweden, 79182 | |
| Principal Investigator: Max Flogegård, MD | |
| Gävle Hospital | Not yet recruiting |
| Gävle, Sweden, 80187 | |
| Principal Investigator: Annika Othzén, MD | |
| Norrland University Hospital | Not yet recruiting |
| Umeå, Sweden, 90185 | |
| Principal Investigator: Karin Forsberg, MD | |
| Sundsvall Hospital | Recruiting |
| Sundsvall, Sweden, 85186 | |
| Principal Investigator: Maria Strandberg, MD | |
| Sunderby hospital | Not yet recruiting |
| Luleå, Sweden, 97180 | |
| Principal Investigator: Birgitta Lauri, MD | |
| Lund University Hospital | Recruiting |
| Lund, Sweden, 22185 | |
| Principal Investigator: Stig Lenhoff, MD, PhD | |
| Principal Investigator: | Martin Hjorth, MD, PhD | Department of Medicine, Lidköping Hospital, S-53185 Lidköping, Sweden |
More Information
| Responsible Party: | Department of Medicine, Lidköping Hospital, S-53185 Lidköping, Sweden ( Martin Hjorth ) |
| Study ID Numbers: | NMSG 17/07, EudraCT no. 2007-001292-11 |
| Study First Received: | January 15, 2008 |
| Last Updated: | August 11, 2008 |
| ClinicalTrials.gov Identifier: | NCT00602511 |
| Health Authority: | Sweden: Medical Products Agency |
|
Melfalan refractory multiple myeloma Multiple myeloma Relapsing Refractory |
Thalidomide Bortezomib Randomized clinical trial |
|
Dexamethasone Melphalan Immunoproliferative Disorders Thalidomide Blood Protein Disorders Hematologic Diseases Blood Coagulation Disorders Bortezomib Vascular Diseases |
Paraproteinemias Hemostatic Disorders Multiple Myeloma Hemorrhagic Disorders Multiple myeloma Lymphoproliferative Disorders Dexamethasone acetate Neoplasms, Plasma Cell |
|
Anti-Infective Agents Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Immune System Diseases Immunologic Factors Antineoplastic Agents Growth Substances Physiological Effects of Drugs Enzyme Inhibitors Immunosuppressive Agents |
Angiogenesis Inhibitors Pharmacologic Actions Protease Inhibitors Anti-Bacterial Agents Neoplasms Therapeutic Uses Cardiovascular Diseases Growth Inhibitors Angiogenesis Modulating Agents Leprostatic Agents |
