NCT00417911

Brief Summary

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P50-P75 for phase_3 multiple-myeloma

Timeline
Completed

Started Dec 2005

Geographic Reach
5 countries

20 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2005

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 3, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 4, 2007

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

June 22, 2010

Status Verified

June 1, 2010

Enrollment Period

3.4 years

First QC Date

January 3, 2007

Last Update Submit

June 17, 2010

Conditions

Multiple Myeloma

Keywords

multiple myelomaautologous stem cell transplantationhigh-dose melphalanbortezomibconsolidationevent free survivalphase III

Outcome Measures

Primary Outcomes (1)

  • 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

    1 year after randomization of the last patient

Secondary Outcomes (8)

  • 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

  • +3 more secondary outcomes

Study Arms (2)

No treatment

ACTIVE COMPARATOR
Drug: bortezomib

Bortezomib consolidation

EXPERIMENTAL

Bortezomib consolidation : 20 injections starting 3 months after ASCT

Drug: bortezomib

Interventions

bortezomibDRUG

Bortezomib 1,3 mg/sqm Days 1,4,8,11 for two 3-week cycles and then once a week for three weeks in 4 4-week cycles

Bortezomib consolidationNo treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Symptomatic myeloma diagnosis according to criteria in 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Hæmatologisk afdeling B, Aalborg Sygehus Syd

Aalborg, DK-9000, Denmark

Location

Hæmatologisk afd. B, Århus Universitetshospital, Amtssygehuset

Århus C, DK-8000, Denmark

Location

Hæmatologisk afdeling L Amtssygehuset i Herlev

Herlev, DK-2730, Denmark

Location

Medicinsk Hæmatologisk afd L4042, Rigshospitalet

København Ø, DK-2100, Denmark

Location

Hæmatologisk afd X, Odense Universitetshospital

Odense C, DK-5000, Denmark

Location

Tampere University Hospital, Dep 10a

Tampere, SF-33 521, Finland

Location

Turku University Hospital, Dept. of Medicine, PL 52,

Turku, SF-20521, Finland

Location

Hemathology department, University State Hospital, Landspitali

Reykjavik, 101, Iceland

Location

Hematologisk seksjon, med avd, Haukeland Universitetssykehus

Bergen, N-5021, Norway

Location

Seksjon for blodsykdommer, Med. avd.,Rikshospitalet

Oslo, N - 0027, Norway

Location

Hematologisk avdeling Ullevål Sykehus

Oslo, N - 0407, Norway

Location

Med avd B, Hematologisk seksjon, Universitetssykehuset Nord Norge

Tromsø, N-9038, Norway

Location

Hematologisk seksjon Regionssykehuset

Trondheim, N - 7006, Norway

Location

Hematologiska klin, Huddinge sjukhus

Huddinge, SE-141 86, Sweden

Location

Hematologkliniken, Universitetssjukhuset

Linköping, SE-581 85, Sweden

Location

University Hospital Lund

Lund, SE-221 85, Sweden

Location

Medicinklin, Universitetssjukhuset MAS,

Malmo, SE-205 02, Sweden

Location

Medicinkliniken, Universitetssjukhuset

Örebro, SE-70185, Sweden

Location

Medicinklin, sekt för hematologi, Norrlands Universitetssjukhus

Umeå, SE-901 85, Sweden

Location

Medicinklin, Akademiska sjukhuset

Uppsala, SE-751 85, Sweden

Location

Related Publications (1)

  • Mellqvist UH, Gimsing P, Hjertner O, Lenhoff S, Laane E, Remes K, Steingrimsdottir H, Abildgaard N, Ahlberg L, Blimark C, Dahl IM, Forsberg K, Gedde-Dahl T, Gregersen H, Gruber A, Guldbrandsen N, Haukas E, Carlson K, Kvam AK, Nahi H, Lindas R, Andersen NF, Turesson I, Waage A, Westin J; Nordic Myeloma Study Group. Bortezomib consolidation after autologous stem cell transplantation in multiple myeloma: a Nordic Myeloma Study Group randomized phase 3 trial. Blood. 2013 Jun 6;121(23):4647-54. doi: 10.1182/blood-2012-11-464503. Epub 2013 Apr 24.

    PMID: 23616624DERIVED

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Bortezomib

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Boronic AcidsAcids, NoncarboxylicAcidsInorganic ChemicalsBoron CompoundsOrganic ChemicalsPyrazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Ulf-Henrik Mellqvist, Dr., PhD

    NMSG

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 3, 2007

First Posted

January 4, 2007

Study Start

December 1, 2005

Primary Completion

May 1, 2009

Study Completion

May 1, 2010

Last Updated

June 22, 2010

Record last verified: 2010-06

Locations

NO(5)SE(7)FI(2)IC(1)DK(5)