Treatment of Newly Diagnosed Elderly Patients With 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

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-05-31

Study Completion Date

2005-10-31

Brief Summary

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In multiple myeloma, combination chemotherapy with melphalan plus prednisone has been used since the 1960s and is regarded as the standard of care in elderly patients. We assess whether the addition of thalidomide to this combination or adapted high-dose chemotherapy, using a melphalan 100 mg/m2 -based regimen, would improve survival.

Detailed Description

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Trial design This multicenter, randomized, controlled trial is conducted by the French Myeloma Intergroup(IFM) in elderly patients with previously untreated multiple myeloma. The primary objectives of the study are to compare the efficacy and safety of MP with MP-Thalidomide or with MEL100 (intermediate-dose melphalan 100 mg/m2 - based treatment). The secondary objective is to compare the efficacy of MP-Thalidomide vs MEL100.

Conditions

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Multiple Myeloma

Keywords

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Multiple myeloma Elderly patients Thalidomide Autologous transplantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Thalidomide

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Stage II or III multiple myeloma according to Durie and Salmon criteria.
* Patients between 65 and 75 years of age
* Previously untreated patients

Exclusion Criteria

* Prior history of another neoplasm (except basocellular cutaneous or cervical epithelioma)
* Primary or associated amyloidosis
* World Health organisation performance index of at least 3
* Significant renal insufficiency with creatinine serum levels of 5.0 mg per deciliter or more
* Cardiac or hepatic dysfunction
* Cerebral circulatory insufficiency
* Absolute contraindication to corticosteroids
* Peripheral neuropathy
* HIV or hepatitis B or C positivity
* Patients who had geographic, social or psychological conditions which might prevent adequate follow-up

Minimum Eligible Age

65 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Jean-Yves MARY

Role: STUDY_DIRECTOR

U717 INSERM universite Paris7, Hopital Saint-Louis, Paris, France

Locations

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Lille University Hospital

Lille, , France

Site Status

Countries

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France

References

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Facon T, Mary JY, Hulin C, Benboubker L, Attal M, Pegourie B, Renaud M, Harousseau JL, Guillerm G, Chaleteix C, Dib M, Voillat L, Maisonneuve H, Troncy J, Dorvaux V, Monconduit M, Martin C, Casassus P, Jaubert J, Jardel H, Doyen C, Kolb B, Anglaret B, Grosbois B, Yakoub-Agha I, Mathiot C, Avet-Loiseau H; Intergroupe Francophone du Myelome. Melphalan and prednisone plus thalidomide versus melphalan and prednisone alone or reduced-intensity autologous stem cell transplantation in elderly patients with multiple myeloma (IFM 99-06): a randomised trial. Lancet. 2007 Oct 6;370(9594):1209-18. doi: 10.1016/S0140-6736(07)61537-2.

Reference Type DERIVED

PMID: 17920916 (View on PubMed)

Other Identifiers

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IFM 99-06

Identifier Type: -

Identifier Source: org_study_id