NCT00218855

Brief Summary

The purpose of this study is to test the effect of thalidomide in patients with multiple myeloma. The patients receive either thalidomide or a placebo tablet (neither patient nor doctor know which of these are given) in addition to the ordinary chemotherapeutic drug against multiple myeloma. We will find out for how long time the patients will stay free of the disease and for how long time they will live, and can evaluate whether thalidomide is a beneficial drug against this disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
363

participants targeted

Target at P50-P75 for phase_3 multiple-myeloma

Timeline
Completed

Started Jan 2002

Geographic Reach
1 country

1 active site

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

January 1, 2002

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

September 20, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
Last Updated

March 7, 2014

Status Verified

March 1, 2014

Enrollment Period

5.2 years

First QC Date

September 20, 2005

Last Update Submit

March 6, 2014

Conditions

Multiple Myeloma

Keywords

Multiple MyelomaPhase 3, randomised, double blind studythalidomide

Outcome Measures

Primary Outcomes (1)

  • overall survival

    october 2007

Secondary Outcomes (9)

  • Quality of life

    october 2007

  • Time to response

    october 2007

  • Frequency of response

    october 2007

  • Time to progression

    october 2007

  • Time to 2. response

    october 2007

  • +4 more secondary outcomes

Study Arms (2)

A

PLACEBO COMPARATOR
Drug: thalidomideDrug: placebo

B

ACTIVE COMPARATOR
Drug: thalidomideDrug: placebo

Interventions

thalidomideDRUG

tablets thalidomide start 100 mg x 2 escalating to 200 mg x 2 until plateau phase. Maintenance 100 mg x 2 until relapse. The same procedure is repeated by first relapse.

Also known as: thalidomide, Talix
AB
placeboDRUG

100 mg x 2 mg tablets escalating to 200 mg x 2 until plateau phase. Maintenance 100 mg x 2 until relapse. This procedure is repeated by first relapse.

Also known as: no other names
AB

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with multiple myeloma in need of treatment

You may not qualify if:

  • Previous treatment against multiple myeloma
  • Need of high dose chemotherapy with autologous stem cell support
  • Women in fertile age
  • Psychiatric disease or mental reduction leading to lack of cooperation
  • Lack of consent
  • Life expectancy below 3 months
  • Active cancer of other etiology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Haematology, St. Olavs hospital/NTNU

Trondheim, N-7006, Norway

Location

Related Publications (1)

  • Waage A, Gimsing P, Fayers P, Abildgaard N, Ahlberg L, Bjorkstrand B, Carlson K, Dahl IM, Forsberg K, Gulbrandsen N, Haukas E, Hjertner O, Hjorth M, Karlsson T, Knudsen LM, Nielsen JL, Linder O, Mellqvist UH, Nesthus I, Rolke J, Strandberg M, Sorbo JH, Wisloff F, Juliusson G, Turesson I; Nordic Myeloma Study Group. Melphalan and prednisone plus thalidomide or placebo in elderly patients with multiple myeloma. Blood. 2010 Sep 2;116(9):1405-12. doi: 10.1182/blood-2009-08-237974. Epub 2010 May 6.

    PMID: 20448107RESULT

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Thalidomide

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)

PhthalimidesPhthalic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidonesPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIsoindolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Anders Waage, MD

    Department of Haematology, St. Olavs hospital/NTNU, N-7006 Trondheim

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2005

First Posted

September 22, 2005

Study Start

January 1, 2002

Primary Completion

April 1, 2007

Study Completion

April 1, 2007

Last Updated

March 7, 2014

Record last verified: 2014-03

Locations

NO(1)