Velcade Combined With High-Dose Dexamethasone in Patients With Newly Diagnosed 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

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-08-31

Brief Summary

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The objective of this study is to evaluate the efficacy and safety of Velcade plus dexamethasone used as induction chemotherapy prior to autologous transplantation.

Detailed Description

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Conditions

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Multiple Myeloma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Dexamethasone

Intervention Type DRUG

velcade

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* diagnosis of MM according to the SWOG criteria (annex 1)
* previously untreated (localized radiotherapy is allowed)
* symptomatic MM stage II or III according to Durie-Salmon staging system (annex 2) or stage I with one symptomatic osteolytic lesion
* with measurable levels of paraprotein in the serum (\> 1g/dl) or in the urine (\> 0.2g/24h)
* age \< 75 years
* able to understand and to given an informed consent
* male, female without childbearing potential or negative urine pregnancy test within 72 hours prior to beginning the treatment. Women of childbearing potential must be following adequate contraceptive measures.
* no active systemic infection. In the presence of any active systemic infection, adequate broad-spectrum or organism-specific antibiotic coverage must be administered. Patients must be a febrile with stable vital signs while receiving antibiotics for at least 48 hours prior to beginning the treatment with Velcade plus dexamethasone.

Exclusion Criteria

* life expectancy \< 2 months
* ECOG performance status \> 2 (annex 3)
* proven amyloidosis
* positive HIV serology
* antecedents of severe psychiatric disease
* severe diabetes contraindicating the use of high-dose corticoïds
* \> NCI grade 2 peripheral neuropathy (Annex IV)
* serum biochemical values as follow

* creatinin level \> 200mmol/l
* bilirubin, transaminases or gGT \> 3 the upper normal limit
* use of any experimental drugs within 30 days of baseline

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Jean-Luc HAROUSSEAU, MD

Role: PRINCIPAL_INVESTIGATOR

NANTES UH

Locations

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Jean-Luc HAROUSSEAU

Nantes, , France

Site Status

Countries

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France

Other Identifiers

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BRD 03/6-E

Identifier Type: -

Identifier Source: org_study_id