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Study of Induction Treatment With Velcade and Dexamethasone for Previously Untreated Patients With Multiple Myeloma and Renal Failure

2014-07-23 21:09:52 | BioPortfolio

Summary

Primary outcome measure:

- Analyze the efficacy (in order to evaluate the response) of Bortezomib/Dexamethasone treatment

Secondary outcome measures:

- Study the speed of response and the response rate (M component in serum and urine protein) after each bortezomib/dexamethasone cycle

- Compare the efficacy of the bortezomib/dexamethasone therapy against the therapy without bortezomib

- Reversibility of renal failure

- Predictive value in the light chain determination for response and reversibility of renal failure

- Early morbidity (< 2 months)

- Progression-free survival

- Overall survival

The safety outcome consists in:

- Determining the safety and tolerance of VELCADE/Dexamethasone, according to the toxicity criteria of clinical and laboratory events

Description

60 patients, 18 years or older, diagnosed with newly symptomatic multiple myeloma (standard diagnosis criteria) and renal failure, previously untreated with chemotherapy, will be included.

It is an multi centric, national and open study designed in order to determine efficacy of the combination of bortezomib and dexamethasone for multiple myeloma patients with renal failure.

The trial consists of two parts: pre-treatment and treatment. Pre- treatment phase: include the enrolment visit in order to determine that the patient is eligible to participate in a study. The patient will be given the Informed Consent Form in order to participate in the study, and detailed information about the treatment, its benefits and risks.

Treatment phase: include the treatment which consist of, at the most, 12 cycles of Velcade and Dexamethasone (induction and extension). During these periods, patients will come to the centre for the study visits to be evaluated, the days they will receive Velcade® of each cycle.

Once the clinical trial has finished, patients will be monitored during short and long-term periods where progression free survival and overall survival will be evaluated.

Study Design

Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Multiple Myeloma

Intervention

velcade

Location

Hospital Germans Trias i Pujol
Badalona
Barcelona
Spain

Status

Not yet recruiting

Source

PETHEMA Foundation

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:09:52-0400

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Medical and Biotech [MESH] Definitions

A rare, aggressive variant of MULTIPLE MYELOMA characterized by the circulation of excessive PLASMA CELLS in the peripheral blood. It can be a primary manifestation of multiple myeloma or develop as a terminal complication during the disease.

Abnormal immunoglobulins characteristic of MULTIPLE MYELOMA.

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A pyrazine and boronic acid derivative that functions as a reversible PROTEASOME INHIBITOR. It is used as an ANTINEOPLASTIC AGENT in the treatment of MULTIPLE MYELOMA and MANTLE CELL LYMPHOMA.

Class I human histocompatibility (HLA) antigens encoded by a small cluster of structural genes at the C locus on chromosome 6. They have significantly lower immunogenicity than the HLA-A and -B determinants and are therefore of minor importance in donor/recipient crossmatching. Their primary role is their high-risk association with certain disease manifestations (e.g., spondylarthritis, psoriasis, multiple myeloma).

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