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Sponsors and Collaborators: |
Nordic Myeloma Study Group Janssen-Cilag Ltd. |
Information provided by: | Nordic Myeloma Study Group |
ClinicalTrials.gov Identifier: | NCT00417911 |
Multiple myeloma is a malignant incurable hematological disease where survival has been significantly improved by high-dose melphalan with autologous stem cell support (ASCT) in younger patients. However, the disease will eventually relapse and new treatment is demanded. Bortezomib is a newly approved drug for treating relapsing multiple myeloma. It has a different biological effect and response even in patients refractory to conventional chemotherapy. The purpose of the study is in a randomized design to investigate if addition of bortezomib by 20 injections during a 4 months period starting 3 month after ASCT can prolong the time to progression compared to patients receiving no consolidation or maintenance therapy.
Condition | Intervention | Phase |
Multiple Myeloma |
Drug: bortezomib |
Phase III |
Genetics Home Reference related topics: | aceruloplasminemia hemophilia |
MedlinePlus related topics: | Multiple Myeloma |
Drug Information available for: | Melphalan Bortezomib Melphalan hydrochloride Sarcolysin |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Clinical Protocol Bortezomib Consolidation in Patients With Myeloma Following Treatment With High-Dose Melphalan and Autologous Stem Cell Support. A Randomised NMSG Trial (15/05) |
Estimated Enrollment: | 400 |
Study Start Date: | December 2005 |
Estimated Study Completion Date: | December 2009 |
Rationale:
ASCT prolongs EFS and OS for myeloma patients < 65 years of age. During the period from ASCT to progression most myeloma patients experience few symptoms and have a good quality of life11. A further prolongation of EFS would be a big step forward in myeloma treatment. Bortezomib is a new promising agent, which has shown clear anti-myeloma effect in heavily pre-treated patients. After ASCT the tumour cell burden is low and it is the hypothesis of this clinical trial that the unique mechanism of action of bortezomib may reduce the number of tumour cells even further and by doing so prolong EFS.
Primary 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
Secondary objectives:
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Ulf-Henrik Mellqvist, dr., PhD | +46 31 3421000 | ulf-henrik.mellqvist@vgregion.se |
Denmark | |||||
Hæmatologisk afdeling L Amtssygehuset i Herlev | Not yet recruiting | ||||
Herlev, Denmark, DK-2730 | |||||
Contact: Annette Vangsted, Dr., +45 44 88 39 25 ANEVAN01@herlevhosp.kbhamt.dk | |||||
Hæmatologisk afd. B, Århus Universitetshospital, Amtssygehuset | Recruiting | ||||
Århus C, Denmark, DK-8000 | |||||
Contact: Johan L Nielsen, Ass.prof. +45 89497553 johan.lanngnielsen@aas.auh.dk | |||||
Medicinsk Hæmatologisk afd L4042, Rigshospitalet | Recruiting | ||||
København Ø, Denmark, DK-2100 | |||||
Contact: Peter Gimsing, Ass.prof. +45 35451755 rhlpgim@rh.dk | |||||
Contact: Lene M Knudsen, Dr., PhD +45 35450798 l.meldgaard@dadlnet.dk | |||||
Hæmatologisk afd X, Odense Universitetshospital | Not yet recruiting | ||||
Odense C, Denmark, DK-5000 | |||||
Contact: Niels Abildgaard, Dr., PhD +45 65 43 11 55 niels.abild@dadlnet.dk | |||||
Hæmatologisk afdeling B, Aalborg Sygehus Syd | Recruiting | ||||
Ålborg, Denmark, DK-9000 | |||||
Contact: Henrik Gregersen, Dr., PhD +45 99 32 24 08 henrik.gregersen@dadlnet.dk | |||||
Finland | |||||
Turku University Hospital, Dept. of Medicine, PL 52, | Recruiting | ||||
Turku, Finland, SF-20521 | |||||
Contact: Kari Remes, Dr., PhD +358-2-313 0016 Kari.Remes@tyks.fi | |||||
Tampere University Hospital, Dep 10a | Not yet recruiting | ||||
Tampere, Finland, SF-33 521 | |||||
Contact: Raija Silvennoinen, Dr., PhD raija.silvennoinen@pshp.fi | |||||
Iceland | |||||
Hemathology department, University State Hospital, Landspitali | Recruiting | ||||
Reykjavik, Iceland, 101 | |||||
Contact: Hlif Steingrimsdottir, Dr., PhD hlifst@landspitali.is | |||||
Norway | |||||
Hematologisk avdeling Ullevål Sykehus | Recruiting | ||||
Oslo, Norway, N - 0407 | |||||
Contact: Jon M Tangen, Dr., PhD +47 2211 9240 jonmagnus.tangen@ulleval.no | |||||
Seksjon for blodsykdommer, Med. avd.,Rikshospitalet | Recruiting | ||||
Oslo, Norway, N - 0027 | |||||
Contact: Tobias Gedde-Dahl, Dr., PhD +47 23070000 Tobias.Gedde-Dahl@rikshospitalet.no | |||||
Hematologisk seksjon Regionssykehuset | Recruiting | ||||
Trondheim, Norway, N - 7006 | |||||
Contact: Jens Hammerstrøm, Dr., PhD +47 73 86 74 73 jens.hammerstrom@medisin.ntnu.no | |||||
Contact: Anders Waage, Professor +47 7386 7473 anders.waage@medisin.ntnu.no | |||||
Med avd B, Hematologisk seksjon, Universitetssykehuset Nord Norge | Not yet recruiting | ||||
Tromsø, Norway, N-9038 | |||||
Contact: Inger-Marie S Dahl, Professor +47 776 26000 inger.marie.dahl@unn.no | |||||
Hematologisk seksjon, med avd, Haukeland Universitetssykehus | Recruiting | ||||
Bergen, Norway, N-5021 | |||||
Contact: Ingerid Nesthus, Dr., PhD +47 55972972 ingerid.nesthus@helse-bergen.no | |||||
Sweden | |||||
Medicinklin, Universitetssjukhuset MAS, | Recruiting | ||||
Malmö, Sweden, SE-205 02 | |||||
Contact: Ingemar Turesson, Dr., PhD +46 40 331000 ingemar.turesson@medforsk.mas.lu.se | |||||
University Hospital Lund | Recruiting | ||||
Lund, Sweden, SE-221 85 | |||||
Contact: Stig Lenhoff, Dr. PhD +46-46-177140 Stig.Lenhoff@skane.se | |||||
Medicinkliniken, Universitetssjukhuset | Recruiting | ||||
Örebro, Sweden, SE-70185 | |||||
Contact: Olle Linder, Dr., PhD +46 19 6021000 olle.linder@orebroll.se | |||||
Medicinklin, Akademiska sjukhuset | Recruiting | ||||
Uppsala, Sweden, SE-751 85 | |||||
Contact: Kristina Carlson, Dr., PhD +46 18 6110000 kristina.carlson@akademiska.se | |||||
Hematologkliniken, Universitetssjukhuset | Recruiting | ||||
Linköping, Sweden, SE-581 85 | |||||
Contact: Lucia Ahlberg, Dr., PhD +46 13 222000 Lucia.Ahlberg@lio.se | |||||
Hematologiska klin, Huddinge sjukhus | Recruiting | ||||
Huddinge, Sweden, SE-141 86 | |||||
Contact: Bo Björkstrand, Dr., PhD +46 8 58587603 Bo.Bjorkstrand@medhs.ki.se | |||||
Medicinklin, sekt för hematologi, Norrlands Universitetssjukhus | Recruiting | ||||
Umeå, Sweden, SE-901 85 | |||||
Contact: Karin Forsberg, Dr. +46 90 7850000 Karin.Forsberg@vll.se |
Nordic Myeloma Study Group |
Janssen-Cilag Ltd. |
Principal Investigator: | Ulf-Henrik Mellqvist, Dr., PhD | NMSG |
NMSG home page 
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Study ID Numbers: | NMSG 15/05, EudraCT No: 2005-002756-18 |
First Received: | January 3, 2007 |
Last Updated: | March 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00417911 |
Health Authority: | Sweden: Medical Products Agency; Sweden: Regional Ethical Review Board |
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