Zoledronic Acid in Patients With Multiple Myeloma and Asymptomatic Biochemical Relapse
AZABACHE
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
1 other identifier
interventional
103
1 country
16
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 multiple-myeloma
Started Apr 2010
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 12, 2010
CompletedFirst Posted
Study publicly available on registry
March 15, 2010
CompletedStudy Start
First participant enrolled
April 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 5, 2013
CompletedApril 6, 2020
April 1, 2020
3.1 years
March 12, 2010
April 3, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
6 months
Secondary Outcomes (5)
Time to symptom relapse
1 year
disease progression
2 years
prognostic factors
2 years
antitumour effect of ZOL
1 year
Overall survival
5 years
Study Arms (2)
Zoledronate acid
EXPERIMENTALNo treatment control
OTHERInterventions
Eligibility Criteria
You may qualify if:
- Male or female patients aged ≥18 years.
- 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
You may not qualify if:
- Criteria of symptomatic disease or organic damage related to disease, defined as:
- Anaemia: haemoglobin \< 10 g/dl or 2 g/dl below normal ranges.
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- PETHEMA Foundationlead
- Dynamic Solutionscollaborator
- Novartiscollaborator
Study Sites (16)
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
Related Publications (4)
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
RESULTR. 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
RESULTR. 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
RESULTGarcia-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.
PMID: 26069291DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
García Sanz Ramon, Dr
PETHEMA Foundation
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 12, 2010
First Posted
March 15, 2010
Study Start
April 1, 2010
Primary Completion
May 1, 2013
Study Completion
June 5, 2013
Last Updated
April 6, 2020
Record last verified: 2020-04