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

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ClinicalTrials.gov Identifier: NCT01087008
Recruitment Status : Completed
First Posted : March 15, 2010
Last Update Posted : April 6, 2020
Sponsor:
Collaborators:
Dynamic Solutions
Novartis
Information provided by (Responsible Party):
PETHEMA Foundation

Study Description
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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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: zoledronic acid Other: No treatment control Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 103 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Actual Study Start Date : April 2010
Actual Primary Completion Date : May 2013
Actual Study Completion Date : June 5, 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Time to symptom relapse [ Time Frame: 1 year ]
    Time to symptom relapse, considered as the time from randomization to symptom relapse

  2. 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).

  3. prognostic factors [ Time Frame: 2 years ]
    To describe the prognostic factors in patients with MM and asymptomatic biochemical relapse

  4. 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

  5. Overall survival [ Time Frame: 5 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01087008


Locations
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Spain
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
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
Sponsors and Collaborators
PETHEMA Foundation
Dynamic Solutions
Novartis
Investigators
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Study Chair: García Sanz Ramon, Dr PETHEMA Foundation
More Information
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Additional Information:

Publications of Results:
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: PETHEMA Foundation
ClinicalTrials.gov Identifier: NCT01087008    
Other Study ID Numbers: AZABACHE: 2009-017440-13
First Posted: March 15, 2010    Key Record Dates
Last Update Posted: April 6, 2020
Last Verified: April 2020
Keywords provided by PETHEMA Foundation:
Multiple Myeloma
Zoledronic acid
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
 Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Zoledronic Acid
Bone Density Conservation Agents
Physiological Effects of Drugs