Multiple Myeloma Clinical Trial
Official title:
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.
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Norway | Department of Haematology, St. Olavs hospital/NTNU | Trondheim |
Lead Sponsor | Collaborator |
---|---|
Norwegian University of Science and Technology | Nordic Myeloma Study Group, Germany, The Research Council of Norway |
Norway,
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
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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