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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
103
Zoledronic acid 4 mg every 4 weeks for a total of 12 treatments
Patients doesn't receive treatment
Hospital Universitari Germans Trias I Pujol
Badalona, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
Hospital del Mar
Barcelona, Spain
Hospital Vall d'Hebrón
Barcelona, Spain
Hospital Clínico San Carlos
Madrid, Spain
Hospital Universitario Ramón y Cajal
Madrid, Spain
Hospital Jose María Morales Meseguer
Murcia, Spain
Hospital Central de Asturias
Oviedo, Spain
Hospital Son Llàtzer
Palma de Mallorca, Spain
Hospital Universitario Son Dureta
Palma de Mallorca, Spain
...and 6 more locations
Time to next need treatment
Time to the next treatment, considered as the time from the randomization date to the start of the next chemotherapy treatment for Multiple Mieloma or death for any cause
Time frame: 6 months
Time to symptom relapse
Time to symptom relapse, considered as the time from randomization to symptom relapse
Time frame: 1 year
disease progression
To describe the differences between patients treated with ZOL or not in terms of type of disease progression (bone and extra-bone).
Time frame: 2 years
prognostic factors
To describe the prognostic factors in patients with MM and asymptomatic biochemical relapse
Time frame: 2 years
antitumour effect of ZOL
To assess the antitumour effect of ZOL on other clinically significant parameters in MM, including tumour response to ZOL
Time frame: 1 year
Overall survival
Time frame: 5 years
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