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Comparison of Melphalan-Prednisone (MP) to MP Plus Thalidomide in the Treatment of Newly Diagnosed Very Elderly Patients (> 75 Years) With Multiple Myeloma

NCT ID: NCT00644306

Last Updated: 2008-03-26

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

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

232 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-04-30

Study Completion Date

2007-05-31

Brief Summary

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In multiple myeloma, combination chemotherapy with melphalan plus prednisone has been usedsince the 1960s and is regarded as the standard of care in very elderly patients. We assess whether the addition of thalidomide at 100 mg/day to this combination would improve survival.

Detailed Description

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Conditions

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Newly Diagnosed, Multiple Myeloma

Keywords

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Multiple Myeloma, very elderly patients, thalidomide

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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A

12 cycles every 6 weeks :melphalan 0.2 mg/kg day 1 to 4, prednisone 2 mg/kg/d day 1 to 4 plus placebo 100mg/d continuously for 18 months

Group Type PLACEBO_COMPARATOR

Thalidomide

Intervention Type DRUG

100 mg/day continuously for 18 months

melphalan, prednisone

Intervention Type DRUG

12 cycles every 6 weeks :melphalan 0.2 mg/kg day 1 to 4, prednisone 2 mg/kg/d day 1 to 4 plus placebo 100mg/d continuously for 18 months

B

12 cycles every 6 weeks :melphalan 0.2 mg/kg day 1 to 4, prednisone 2 mg/kg/d day 1 to 4 plus thalidomide 100mg/d continuously for 18 months

Group Type ACTIVE_COMPARATOR

melphalan, prednisone, thalidomide

Intervention Type DRUG

12 cycles every 6 weeks :melphalan 0.2 mg/kg day 1 to 4, prednisone 2 mg/kg/d day 1 to 4 plus thalidomide 100mg/d continuously for 18 months

Interventions

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Thalidomide

100 mg/day continuously for 18 months

Intervention Type DRUG

melphalan, prednisone

12 cycles every 6 weeks :melphalan 0.2 mg/kg day 1 to 4, prednisone 2 mg/kg/d day 1 to 4 plus placebo 100mg/d continuously for 18 months

Intervention Type DRUG

melphalan, prednisone, thalidomide

12 cycles every 6 weeks :melphalan 0.2 mg/kg day 1 to 4, prednisone 2 mg/kg/d day 1 to 4 plus thalidomide 100mg/d continuously for 18 months

Intervention Type DRUG

Other Intervention Names

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Alkeran, cortancyl Alkeran, cortancyl

Eligibility Criteria

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Inclusion Criteria

* Stage II or III multiple myeloma according to Durie and Salmon criteria, patients older than 75 years, previously untreated patients.

Exclusion Criteria

* Prior history of another neoplasm (except basocellular cutaneous or cervical epithelioma)
* Primary or associated amyloïdosis
* 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 clinically significant
* History of venous thrombosis during the last 6 months
* HIV or hepatitis B or C positivity
* Patients who had geography, social, or psychological conditions which might prevent adequate follow-up.
Minimum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Central Hospital, Nancy, France

OTHER

Sponsor Role lead

Responsible Party

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Intergroupe Francophone du Myélome (IFM)

Principal Investigators

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Cyrille Hulin, MD

Role: PRINCIPAL_INVESTIGATOR

Hematology CHU Nancy and Intergroupe Francophone du Myelome (IFM)

Locations

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CHU Nancy - Brabois, rue du morvan

Vandœuvre-lès-Nancy, , 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 BACKGROUND
PMID: 17920916 (View on PubMed)

Other Identifiers

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University Hospital, Nancy

Identifier Type: -

Identifier Source: org_study_id