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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00218855
Other study ID # NMSG #12
Secondary ID NFR 90000288
Status Completed
Phase Phase 3
First received September 20, 2005
Last updated March 6, 2014
Start date January 2002
Est. completion date April 2007

Study information

Verified date March 2014
Source Norwegian University of Science and Technology
Contact n/a
Is FDA regulated No
Health authority Norway: Norwegian Medicines Agency
Study type Interventional

Clinical Trial 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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 363
Est. completion date April 2007
Est. primary completion date April 2007
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
Norway Department of Haematology, St. Olavs hospital/NTNU Trondheim

Sponsors (3)

Lead Sponsor Collaborator
Norwegian University of Science and Technology Nordic Myeloma Study Group, Germany, The Research Council of Norway

Country where clinical trial is conducted

Norway, 

References & Publications (1)

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, Wi — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary overall survival october 2007 No
Secondary Quality of life october 2007 No
Secondary Time to response october 2007 No
Secondary Frequency of response october 2007 No
Secondary Time to progression october 2007 No
Secondary Time to 2. response october 2007 No
Secondary Frequency of 2. response october 2007 No
Secondary Time to 2. progression october 2007 No
Secondary Toxicity october 2007 No
Secondary Time to definitive treatment failure october 2007 No
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