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Zoledronic Acid in Patients With Multiple Myeloma and Asymptomatic Biochemical Relapse (AZABACHE)

Primary Purpose

Multiple Myeloma

Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
zoledronic acid
No treatment control
Sponsored by
PETHEMA Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Multiple Myeloma focused on measuring Multiple Myeloma, Zoledronic acid

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Treatment with bisphosphonates (oral route and/or endovenous route) within 3 months prior to inclusion.
  • 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

Sites / Locations

  • Hospital Universitari Germans Trias I Pujol
  • Hospital de la Santa Creu i Sant Pau
  • Hospital del Mar
  • Hospital Vall d'Hebrón
  • Hospital Clínico San Carlos
  • Hospital Universitario Ramón y Cajal
  • Hospital Jose María Morales Meseguer
  • Hospital Central de Asturias
  • Hospital Son Llàtzer
  • Hospital Universitario Son Dureta
  • Hospital Universitario de Salamanca
  • Hospital Universitario de Canarias
  • Hospital Clínico Universitario de Valencia
  • Hospital Universitario Dr. Peset.
  • Hospital Universitario La Fe
  • Hospital Clínico Lozano Blesa

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Zoledronate acid

No treatment control

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Time to symptom relapse
Time to symptom relapse, considered as the time from randomization to symptom relapse
disease progression
To describe the differences between patients treated with ZOL or not in terms of type of disease progression (bone and extra-bone).
prognostic factors
To describe the prognostic factors in patients with MM and asymptomatic biochemical relapse
antitumour effect of ZOL
To assess the antitumour effect of ZOL on other clinically significant parameters in MM, including tumour response to ZOL
Overall survival

Full Information

First Posted
March 12, 2010
Last Updated
April 3, 2020
Sponsor
PETHEMA Foundation
Collaborators
Dynamic Solutions, Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT01087008
Brief Title
Zoledronic Acid in Patients With Multiple Myeloma and Asymptomatic Biochemical Relapse
Acronym
AZABACHE
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
April 2010 (Actual)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
June 5, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PETHEMA Foundation
Collaborators
Dynamic Solutions, Novartis

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Multiple Myeloma, Zoledronic acid

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
103 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Zoledronate acid
Arm Type
Experimental
Arm Title
No treatment control
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
zoledronic acid
Intervention Description
Zoledronic acid 4 mg every 4 weeks for a total of 12 treatments
Intervention Type
Other
Intervention Name(s)
No treatment control
Intervention Description
Patients doesn't receive treatment
Primary Outcome Measure Information:
Title
Time to next need treatment
Description
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
Secondary Outcome Measure Information:
Title
Time to symptom relapse
Description
Time to symptom relapse, considered as the time from randomization to symptom relapse
Time Frame
1 year
Title
disease progression
Description
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
Title
prognostic factors
Description
To describe the prognostic factors in patients with MM and asymptomatic biochemical relapse
Time Frame
2 years
Title
antitumour effect of ZOL
Description
To assess the antitumour effect of ZOL on other clinically significant parameters in MM, including tumour response to ZOL
Time Frame
1 year
Title
Overall survival
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Treatment with bisphosphonates (oral route and/or endovenous route) within 3 months prior to inclusion. 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
García Sanz Ramon, Dr
Organizational Affiliation
PETHEMA Foundation
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital Universitari Germans Trias I Pujol
City
Badalona
Country
Spain
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
Country
Spain
Facility Name
Hospital del Mar
City
Barcelona
Country
Spain
Facility Name
Hospital Vall d'Hebrón
City
Barcelona
Country
Spain
Facility Name
Hospital Clínico San Carlos
City
Madrid
Country
Spain
Facility Name
Hospital Universitario Ramón y Cajal
City
Madrid
Country
Spain
Facility Name
Hospital Jose María Morales Meseguer
City
Murcia
Country
Spain
Facility Name
Hospital Central de Asturias
City
Oviedo
Country
Spain
Facility Name
Hospital Son Llàtzer
City
Palma de Mallorca
Country
Spain
Facility Name
Hospital Universitario Son Dureta
City
Palma de Mallorca
Country
Spain
Facility Name
Hospital Universitario de Salamanca
City
Salamanca
Country
Spain
Facility Name
Hospital Universitario de Canarias
City
Tenerife
Country
Spain
Facility Name
Hospital Clínico Universitario de Valencia
City
Valencia
Country
Spain
Facility Name
Hospital Universitario Dr. Peset.
City
Valencia
Country
Spain
Facility Name
Hospital Universitario La Fe
City
Valencia
Country
Spain
Facility Name
Hospital Clínico Lozano Blesa
City
Zaragoza
Country
Spain

12. IPD Sharing Statement

Citations:
Citation
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 Reference
result
Citation
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 Reference
result
Citation
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
Results Reference
result
PubMed Identifier
26069291
Citation
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.
Results Reference
derived
Links:
URL
http://www.novartis.es
Description
Novartis web page
URL
http://aehh.org
Description
Spnish Association of Haematology

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Zoledronic Acid in Patients With Multiple Myeloma and Asymptomatic Biochemical Relapse

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