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

April 3, 2020 updated by: PETHEMA Foundation

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

103

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Badalona, Spain
        • Hospital Universitari Germans Trias i Pujol
      • Barcelona, Spain
        • Hospital del Mar
      • Barcelona, Spain
        • Hospital de la Santa Creu i Sant Pau
      • Barcelona, Spain
        • Hospital Vall d'Hebron
      • Madrid, Spain
        • Hospital Clinico San Carlos
      • Madrid, Spain
        • Hospital Universitario Ramon y Cajal
      • Murcia, Spain
        • Hospital Jose Maria Morales Meseguer
      • Oviedo, Spain
        • Hospital Central de Asturias
      • Palma de Mallorca, Spain
        • Hospital Son Llatzer
      • Palma de Mallorca, Spain
        • Hospital Universitario Son Dureta
      • Salamanca, Spain
        • Hospital Universitario de Salamanca
      • Tenerife, Spain
        • Hospital Universitario de Canarias
      • Valencia, Spain
        • Hospital Clínico Universitario de Valencia
      • Valencia, Spain
        • Hospital Universitario La Fe
      • Valencia, Spain
        • Hospital Universitario Dr. Peset.
      • Zaragoza, Spain
        • Hospital Clinico Lozano Blesa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Zoledronate acid
Drug: zoledronic acid
Zoledronic acid 4 mg every 4 weeks for a total of 12 treatments
Other: No treatment control
Other: No treatment control
Patients doesn't receive treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to next need treatment
Time Frame: 6 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 5 years
5 years
Time to symptom relapse
Time Frame: 1 year
Time to symptom relapse, considered as the time from randomization to symptom relapse
1 year
disease progression
Time Frame: 2 years
To describe the differences between patients treated with ZOL or not in terms of type of disease progression (bone and extra-bone).
2 years
prognostic factors
Time Frame: 2 years
To describe the prognostic factors in patients with MM and asymptomatic biochemical relapse
2 years
antitumour effect of ZOL
Time Frame: 1 year
To assess the antitumour effect of ZOL on other clinically significant parameters in MM, including tumour response to ZOL
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PETHEMA Foundation

Collaborators

Novartis
Dynamic Solutions

Investigators

  • Study Chair: García Sanz Ramon, Dr, PETHEMA Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2010

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

June 5, 2013

Study Registration Dates

First Submitted

March 12, 2010

First Submitted That Met QC Criteria

March 12, 2010

First Posted (Estimate)

March 15, 2010

Study Record Updates

Last Update Posted (Actual)

April 6, 2020

Last Update Submitted That Met QC Criteria

April 3, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AZABACHE: 2009-017440-13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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