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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 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

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

Page last updated: August 23, 2015

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