Thalidomide to Patients With Previously Untreated Multiple Myeloma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

363 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-01-31

Study Completion Date

2007-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Multiple Myeloma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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A

Group Type PLACEBO_COMPARATOR

thalidomide

Intervention Type DRUG

tablets thalidomide start 100 mg x 2 escalating to 200 mg x 2 until plateau phase. Maintenance 100 mg x 2 until relapse. The same procedure is repeated by first relapse.

placebo

Intervention Type DRUG

100 mg x 2 mg tablets escalating to 200 mg x 2 until plateau phase. Maintenance 100 mg x 2 until relapse. This procedure is repeated by first relapse.

B

Group Type ACTIVE_COMPARATOR

thalidomide

Intervention Type DRUG

tablets thalidomide start 100 mg x 2 escalating to 200 mg x 2 until plateau phase. Maintenance 100 mg x 2 until relapse. The same procedure is repeated by first relapse.

placebo

Intervention Type DRUG

100 mg x 2 mg tablets escalating to 200 mg x 2 until plateau phase. Maintenance 100 mg x 2 until relapse. This procedure is repeated by first relapse.

Interventions

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thalidomide

tablets thalidomide start 100 mg x 2 escalating to 200 mg x 2 until plateau phase. Maintenance 100 mg x 2 until relapse. The same procedure is repeated by first relapse.

Intervention Type DRUG

placebo

100 mg x 2 mg tablets escalating to 200 mg x 2 until plateau phase. Maintenance 100 mg x 2 until relapse. This procedure is repeated by first relapse.

Intervention Type DRUG

Other Intervention Names

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thalidomide, Talix no other names

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No