Multiple Myeloma Clinical Trial
Official title:
Assessment of the Antitumour Effect of Zoledronic Acid in Patients With Multiple Myeloma and Asymptomatic Biochemical Relapse: Prospective Clinical Trial of the GEM/PETHEMA Group
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.
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 ;
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