Clinical trial NCT00218855: Thalidomide to Patients With Previously Untreated Multiple Myeloma
Official title: A Phase 3 Study With Randomization to Melphalan/Prednisone/Thalidomide Versus Melphalan/Prednisone/Placebo to Patients With Previously Untreated Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Multiple Myeloma
Keywords: Multiple Myeloma
Phase 3, randomised, double blind study
thalidomide
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: The Research Council of Norway
name: Nordic Myeloma Study Group, Germany
First posted: 2005-09-22
Enrollment: 363
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: overall survival
timeFrame: october 2007
Secondary outcomes:
measure: Quality of life
timeFrame: october 2007
measure: Time to response
timeFrame: october 2007
measure: Frequency of response
timeFrame: october 2007
measure: Time to progression
timeFrame: october 2007
measure: Time to 2. response
timeFrame: october 2007
measure: Frequency of 2. response
timeFrame: october 2007
measure: Time to 2. progression
timeFrame: october 2007
measure: Toxicity
timeFrame: october 2007
measure: Time to definitive treatment failure
timeFrame: october 2007
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Department of Haematology, St. Olavs hospital/NTNU
Study officials:
affiliation: Department of Haematology, St. Olavs hospital/NTNU, N-7006 Trondheim
name: Anders Waage, MD
role: STUDY_CHAIR
References:
citation: 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.