Thalidomide to Patients With Previously Untreated Multiple Myeloma
Information source: Norwegian University of Science and Technology
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Multiple Myeloma
Intervention: thalidomide (Drug); placebo (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Norwegian University of Science and Technology Official(s) and/or principal investigator(s): Anders Waage, MD, Study Chair, Affiliation: Department of Haematology, St. Olavs hospital/NTNU, N-7006 Trondheim
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.
Clinical Details
Official title: A Phase 3 Study With Randomization to Melphalan/Prednisone/Thalidomide Versus Melphalan/Prednisone/Placebo to Patients With Previously Untreated Multiple Myeloma
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: overall survival
Secondary outcome: Quality of lifeTime 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
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
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Department of Haematology, St. Olavs hospital/NTNU, Trondheim N-7006, Norway
Additional Information
Starting date: January 2002
Last updated: March 6, 2014
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