This trial is active, not recruiting.

Condition multiple myeloma
Treatments zoledronic acid, no treatment control
Phase phase 4
Sponsor PETHEMA Foundation
Collaborator Dynamic Solutions
Start date April 2010
End date May 2013
Trial size 103 participants
Trial identifier NCT01087008, AZABACHE: 2009-017440-13


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
zoledronic acid
Zoledronic acid 4 mg every 4 weeks for a total of 12 treatments
no treatment control
Patients doesn't receive treatment

Primary Outcomes

Time to next need treatment
time frame: 6 months

Secondary Outcomes

Time to symptom relapse
time frame: 1 year
disease progression
time frame: 2 years
prognostic factors
time frame: 2 years
antitumour effect of ZOL
time frame: 1 year
Overall survival
time frame: 5 years

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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
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
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by PETHEMA Foundation.