Zoledronic Acid in Patients With Multiple Myeloma and Asymptomatic Biochemical Relapse

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.

Timeline

Start

2010-04

Primary completion

2013-05

Completion

2013-06-05

Publications

• Results R. García-Sanz, A. Oriol, J. de la Rubia, L. Palomera, P. Ribas, MT. Hernández, MJ. Moreno, J. Bargay, A. Ramírez, AI. Teruel, MJ. Blanchard, M. Gironella, M. Granell, E. Abellá, MA Sampol, R. Martínez, JF San Miguel EVALUTION OF BENEFITS AND POTENTIAL ANTIMYELOMA EFFECT OF ZOLEDRONIC ACID IN PATIENTS WITH ASYMPTOMATIC BIOCHEMICAL RELAPSES. Abstract for ASH 2012
• Results R. García-Sanz, A. Oriol, J. de la Rubia, L. Palomera, P. Ribas, MT. Hernández, MJ. Moreno, J. Bargay, A. Ramírez, AI. Teruel, MJ. Blanchard, M. Gironella, M. Granell, E. Abellá, MA Sampol, R. Martínez, JF San Miguel EVALUTION OF BENEFITS AND POTENTIAL ANTIMYELOMA EFFECT OF ZOLEDRONIC ACID IN PATIENTS WITH ASYMPTOMATIC BIOCHEMICAL RELAPSES. Abstract for EHA 2012
• Results R. García-Sanz, A. Oriol, J. de la Rubia, L. Palomera, P. Ribas, MT. Hernández, MJ. Moreno, J. Bargay, A. Ramírez, AI. Teruel, MJ. Blanchard, M. Gironella, M. Granell, E. Abellá, MA Sampol, R. Martínez, JF San Miguel EVALUTION OF BENEFITS AND POTENTIAL ANTIMYELOMA EFFECT OF ZOLEDRONIC ACID IN PATIENTS WITH ASYMPTOMATIC BIOCHEMICAL RELAPSES. Poster for EHA 2012
• Garcia-Sanz R, Oriol A, Moreno MJ, de la Rubia J, Payer AR, Hernandez MT, Palomera L, Teruel AI, Blanchard MJ, Gironella M, Ribas P, Bargay J, Abella E, Granell M, Ocio EM, Ribera JM, San Miguel JF, Mateos MV; Spanish Myeloma Group (GEM/PETHEMA). Zoledronic acid as compared with observation in multiple myeloma patients at biochemical relapse: results of the randomized AZABACHE Spanish trial. Haematologica. 2015 Sep;100(9):1207-13. doi: 10.3324/haematol.2015.128439. Epub 2015 Jun 11.

Drugs

Indications