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Multiple MyelomaPhase 4AZABACHENCT01087008

Zoledronic Acid in Patients With Multiple Myeloma and Asymptomatic Biochemical Relapse

A Phase 4 study testing zoledronic acid in people with Multiple Myeloma, run by PETHEMA Foundation at 16 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Myeloma
What is being tested?
zoledronic acid
Could I receive a placebo?
No, everyone receives an active treatment
How many people
103 participants
Where
16 sitesSpain
Study dates
Apr 2010to 5 Jun 2013
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 18Show fewer
  • 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

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

Spain16 sites

  • Hospital Universitari Germans Trias I Pujol

    Badalona

  • Hospital de la Santa Creu i Sant Pau

    Barcelona

  • Hospital del Mar

    Barcelona

  • Hospital Vall d'Hebrón

    Barcelona

  • Hospital Clínico San Carlos

    Madrid

  • Hospital Universitario Ramón y Cajal

    Madrid

  • Hospital Jose María Morales Meseguer

    Murcia

  • Hospital Central de Asturias

    Oviedo

  • Hospital Son Llàtzer

    Palma de Mallorca

  • Hospital Universitario Son Dureta

    Palma de Mallorca

  • Hospital Universitario de Salamanca

    Salamanca

  • Hospital Universitario de Canarias

    Santa Cruz de Tenerife

  • Hospital Clínico Universitario de Valencia

    Valencia

  • Hospital Universitario Dr. Peset.

    Valencia

  • Hospital Universitario La Fe

    Valencia

  • Hospital Clínico Lozano Blesa

    Zaragoza

Other trials in Spain

About this study

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

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.
Read the 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

Being tested
zoledronic acid, No treatment control
Keywords
Multiple Myeloma, Zoledronic acid
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • zoledronic acidDrug

    Zoledronic acid 4 mg every 4 weeks for a total of 12 treatments

  • No treatment controlOther

    Patients doesn't receive treatment

Study groups in NCT01087008
Study groupRoleWhat they receive
Zoledronate acidExperimentalNot described
Receives: Drug: zoledronic acid
No treatment controlOtherNot described
Receives: Other: No treatment control

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 6 months

Secondary outcomes (5)

  1. Time to symptom relapse

    Time to symptom relapse, considered as the time from randomization to symptom relapse

    Measured: 1 year

  2. disease progression

    To describe the differences between patients treated with ZOL or not in terms of type of disease progression (bone and extra-bone).

    Measured: 2 years

  3. prognostic factors

    To describe the prognostic factors in patients with MM and asymptomatic biochemical relapse

    Measured: 2 years

  4. antitumour effect of ZOL

    To assess the antitumour effect of ZOL on other clinically significant parameters in MM, including tumour response to ZOL

    Measured: 1 year

  5. Overall survival

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Mar 2010 (estimated)
  2. Study startApr 2010
  3. Primary completionMay 2013
  4. Study completion5 Jun 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
103 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01087008
Sponsor's protocol ID
AZABACHE: 2009-017440-13
Acronym
AZABACHE
Status last verified
Apr 2020
First submitted
12 Mar 2010
Last updated
6 Apr 2020
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 26069291

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing zoledronic acid in people with Multiple Myeloma, run by PETHEMA Foundation at 16 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to next need treatment (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01087008, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2020.

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