IFM 99-02 Thalidomide in Myeloma

NCT ID: NCT00222053

Last Updated: 2010-04-02

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

800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-04-30

Study Completion Date

2009-12-31

Brief Summary

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Principal objective is to evaluate the impact of Thalidomide to prolong the duration of response after autologous transplantation for myeloma

Detailed Description

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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

NONE

Study Groups

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1

No specific intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

2

Biphosphonates

Group Type ACTIVE_COMPARATOR

Biphosphonates

Intervention Type DRUG

Biphosphonates

3

Thalidomide

Group Type EXPERIMENTAL

Thalidomide

Intervention Type DRUG

Per os thalidomide

Interventions

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Thalidomide

Per os thalidomide

Intervention Type DRUG

Biphosphonates

Biphosphonates

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* de novo myeloma
* according to Durie and Salmon classification stage II, III and stage I with a lytic bone lesion
* patients from 18 to 65 years old
* beta2microglobulin \< 3 mg/l or del13 absent
* signed informed consent
* eligible for transplantation

Exclusion Criteria

* peripheral neurological toxicities
* uncontrolled or severe cardiovascular disease
* other malignancy except basocellular carcinoma or FIGO stage I carcinoma of the cervix
* patient who received biphosphonate during the last 60 days
* renal failure definited as creatinine \> 150 µmol/l
* patient with obvious vascular cerebral medical history
* liver dysfunction definited as bilirubin \> 35 µmol/l or ASAT, ALAT, PAL \> 4N
* respiratory dysfunction
* HIV +
* Patient who refused to use an acceptable barrier method for contraception
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Toulouse

OTHER

Sponsor Role lead

Responsible Party

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University Hospital Toulouse

Principal Investigators

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ATTAL Michel, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

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Médecine Interne, CHU Purpan

Toulouse, , France

Site Status

Médecine Interne, Hôpital Rangueil

Toulouse, , France

Site Status

Rhumatologie, CHU Purpan

Toulouse, , France

Site Status

Rhumatologie, CHU Rangueil

Toulouse, , France

Site Status

Service d'hématologie, CHU Purpan

Toulouse, , France

Site Status

Countries

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France

References

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Combination chemotherapy versus melphalan plus prednisone as treatment for multiple myeloma: an overview of 6,633 patients from 27 randomized trials. Myeloma Trialists' Collaborative Group. J Clin Oncol. 1998 Dec;16(12):3832-42. doi: 10.1200/JCO.1998.16.12.3832.

Reference Type BACKGROUND
PMID: 9850028 (View on PubMed)

Attal M, Harousseau JL, Stoppa AM, Sotto JJ, Fuzibet JG, Rossi JF, Casassus P, Maisonneuve H, Facon T, Ifrah N, Payen C, Bataille R. A prospective, randomized trial of autologous bone marrow transplantation and chemotherapy in multiple myeloma. Intergroupe Francais du Myelome. N Engl J Med. 1996 Jul 11;335(2):91-7. doi: 10.1056/NEJM199607113350204.

Reference Type BACKGROUND
PMID: 8649495 (View on PubMed)

Other Identifiers

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PHRC 98-45-N

Identifier Type: -

Identifier Source: org_study_id

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