Zoledronic Acid in Patients With Multiple Myeloma and Asymptomatic Biochemical Relapse
NCT ID: NCT01087008
Last Updated: 2020-04-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
103 participants
INTERVENTIONAL
2010-04-30
2013-06-05
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Zoledronate acid
zoledronic acid
Zoledronic acid 4 mg every 4 weeks for a total of 12 treatments
No treatment control
No treatment control
Patients doesn't receive treatment
Interventions
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zoledronic acid
Zoledronic acid 4 mg every 4 weeks for a total of 12 treatments
No treatment control
Patients doesn't receive treatment
Eligibility Criteria
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Inclusion Criteria
* Signed informed consent before performing any study procedure that is not the part of the regular medical care of the patients.
* Diagnosis of MM, with biochemical relapse after initial response with no symptoms resulting from the disease (CRAB), defined as a re-positivation of a previous immunofixation (two samples) or increase above 25% of serum or urine protein M.
* In the investigator's opinion, ability to meet all clinical trial requirements
Exclusion Criteria
* Treatment with denosumab within three months prior to inclusion.
* Criteria of symptomatic disease or organic damage related to disease, defined as:
* Impaired renal function: serum creatinine \>2 mg/dl or 173 mmol/l. Calcium increase: serum calcium ≥12 mg/dl within 28 days prior to inclusion.
* Anaemia: haemoglobin \< 10 g/dl or 2 g/dl below normal ranges.
* Bone injury: new osteolytic lesions (from diagnosis) seen within 3 months prior to inclusion, current pathological fractures or increase of osteopenia (from diagnosis) in bone radiology series.
* Others: amyloidosis with current organic damage, recurrent bacterial infections (more than 2 events in 12 months), symptomatic hyperviscosity, presence of plasmacytomas.
* Patients with current and active dental disorders (dental, jaw infection, bone exposed in the mouth, jaw osteonecrosis).
* Patients developing jaw osteonecrosis or other serious adverse events due to treatment with any bisphosphonate .
* Significant liver disease:
* Bilirubin \> 3 g/dl.
* ALT \> 2.5 x the upper limit of normal
* AST \> 2.5 x the upper limit of normal
* Patients who are currently in another clinical trial or receiving any investigational agent.
* Pregnancy or nursing.
* Parathyroid gland diseases.
* Previous malignancy with a high risk of death or bone disease: breast cancer, prostate cancer or lung cancer, even if on complete response.
* Active presence of neoplasms other than Multiple Myeloma
18 Years
ALL
No
Sponsors
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Dynamic Solutions
INDUSTRY
Novartis
INDUSTRY
PETHEMA Foundation
OTHER
Responsible Party
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Principal Investigators
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García Sanz Ramon, Dr
Role: STUDY_CHAIR
PETHEMA Foundation
Locations
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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
Hospital Universitario de Salamanca
Salamanca, , Spain
Hospital Universitario de Canarias
Santa Cruz de Tenerife, , Spain
Hospital Clínico Universitario de Valencia
Valencia, , Spain
Hospital Universitario Dr. Peset.
Valencia, , Spain
Hospital Universitario La Fe
Valencia, , Spain
Hospital Clínico Lozano Blesa
Zaragoza, , Spain
Countries
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References
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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
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
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.
Related Links
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Novartis web page
Spnish Association of Haematology
Other Identifiers
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AZABACHE: 2009-017440-13
Identifier Type: -
Identifier Source: org_study_id
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