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Zoledronic Acid in Patients With Multiple Myeloma and Asymptomatic Biochemical Relapse

2014-07-23 21:09:50 | BioPortfolio

Summary

Assessment of the antitumour effect of zoledronic acid in patients with multiple myeloma and asymptomatic biochemical relapse

It´s proposed to investigate the use of Zoledronic acid as single therapy in patients with Multiple Myeloma in biochemical relapse. The following must be noted:

- Patients with no formal indication for chemotherapy treatment will be included, as patients with symptomatic myeloma who after responding show biochemical relapse are generally not treated. This allows for generating both a group of patients untreated, on no additional treatment and a treatment group on zoledronic acid.

- As these are relapsing symptomatic patients, their number is far higher than patients with quiescent Multiple Myeloma. This allows for expecting a good enrolment.

- There are few reliable data on symptom progression after biochemical relapse, though it is one of the new objectives occurring in almost all clinical trials on myeloma. In the VISTA study, it has been estimated that the median time to the new treatment is 5 months (combining progression-free time and time to the next treatment). This time is much shorter than the median quiescent myeloma progression-free survival, so a very long follow-up time will not be necessary in this patient group.

- The administration of this drug to these patients can help prevent skeleton-related complications in the future, the study of which will be a secondary objective of this study.

Description

Zometa is administrated every 4 weeks at dose of 4 mg. The limit of administrations is 12. The first infusion is in the visit 2 and the last is in visit 13

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Conditions

Multiple Myeloma

Intervention

zoledronic acid, No treatment control

Location

Hospital Universitari Germans Trias I Pujol
Badalona
Spain

Status

Recruiting

Source

PETHEMA Foundation

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:09:50-0400

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Medical and Biotech [MESH] Definitions

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Myeloma is a malignant disease of the bone marrow. The features are an excess of abnormal malignant plasma cells in the bone marrow, lytic deposits on an X-ray and abnormal gammaglobulin in the serum.  Symptoms include tiredness and bone pain, and t...


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