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Thalidomide to Patients With Previously Untreated Multiple Myeloma

N

Norwegian University of Science and Technology

Status and phase

Completed
Phase 3

Conditions

Multiple Myeloma

Treatments

Drug: placebo
Drug: thalidomide

Study type

Interventional

Funder types

Other

Identifiers

NCT00218855
NFR 90000288
NMSG #12

Details and patient eligibility

About

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.

Full 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.

Enrollment

363 patients

Sex

All

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

363 participants in 2 patient groups, including a placebo group

A
Placebo Comparator group
Treatment:
Drug: thalidomide
Drug: placebo
B
Active Comparator group
Treatment:
Drug: thalidomide
Drug: placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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