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Thalidomide to Patients With Previously Untreated Multiple Myeloma

This study has been completed.
Sponsor:
Collaborators:
The Research Council of Norway
Nordic Myeloma Study Group, Germany
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT00218855
First received: September 20, 2005
Last updated: March 6, 2014
Last verified: March 2014

September 20, 2005
March 6, 2014
January 2002
April 2007   (final data collection date for primary outcome measure)
overall survival [ Time Frame: october 2007 ] [ Designated as safety issue: No ]
overall survival
Complete list of historical versions of study NCT00218855 on ClinicalTrials.gov Archive Site
  • Quality of life [ Time Frame: october 2007 ] [ Designated as safety issue: No ]
  • Time to response [ Time Frame: october 2007 ] [ Designated as safety issue: No ]
  • Frequency of response [ Time Frame: october 2007 ] [ Designated as safety issue: No ]
  • Time to progression [ Time Frame: october 2007 ] [ Designated as safety issue: No ]
  • Time to 2. response [ Time Frame: october 2007 ] [ Designated as safety issue: No ]
  • Frequency of 2. response [ Time Frame: october 2007 ] [ Designated as safety issue: No ]
  • Time to 2. progression [ Time Frame: october 2007 ] [ Designated as safety issue: No ]
  • Toxicity [ Time Frame: october 2007 ] [ Designated as safety issue: No ]
  • Time to definitive treatment failure [ Time Frame: october 2007 ] [ Designated as safety issue: No ]
  • Quality of life
  • Time to response
  • Frequency of response
  • Time to progression
  • Time to 2. response
  • Frequency of 2. response
  • Time to 2. progression
  • Toxicity
  • Time to definitive treatment failure
Not Provided
Not Provided
 
Thalidomide to Patients With Previously Untreated Multiple Myeloma
A Phase 3 Study With Randomization to Melphalan/Prednisone/Thalidomide Versus Melphalan/Prednisone/Placebo to Patients With Previously Untreated Multiple Myeloma

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.

Thalidomide has recently emerged as an effective treatment for patients with myeloma refractory to conventional chemotherapy. So far only limited experience is available on thalidomide for newly diagnosed myeloma. Therefore the Nordic Myeloma Study Group decided to perform a trial comparing traditional melphalan-prednisone therapy with melphalan-prednisone + thalidomide/placebo. The study design is a multicentre double-blind randomised placebo-controlled trial. Mainly patients >65 years of age will be included since patients <65 years will be treated with high dose chemotherapy with autologous stem cell support. The primary end-point is overall survival. Secondary end-points are quality of life, response rate, time to response, response duration and toxicity.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Multiple Myeloma
  • Drug: thalidomide
    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.
    Other Name: thalidomide, Talix
  • Drug: placebo
    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.
    Other Name: no other names
  • Placebo Comparator: A
    Interventions:
    • Drug: thalidomide
    • Drug: placebo
  • Active Comparator: B
    Interventions:
    • Drug: thalidomide
    • Drug: placebo
Waage A, Gimsing P, Fayers P, Abildgaard N, Ahlberg L, Björkstrand B, Carlson K, Dahl IM, Forsberg K, Gulbrandsen N, Haukås E, Hjertner O, Hjorth M, Karlsson T, Knudsen LM, Nielsen JL, Linder O, Mellqvist UH, Nesthus I, Rolke J, Strandberg M, Sørbø JH, Wisløff 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
363
April 2007
April 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with multiple myeloma in need of treatment

Exclusion Criteria:

  • 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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT00218855
NMSG #12, NFR 90000288
No
Norwegian University of Science and Technology
Norwegian University of Science and Technology
  • The Research Council of Norway
  • Nordic Myeloma Study Group, Germany
Study Chair: Anders Waage, MD Department of Haematology, St. Olavs hospital/NTNU, N-7006 Trondheim
Norwegian University of Science and Technology
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP