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

PETHEMA Foundation

Status and phase

Completed

Phase 4

Conditions

Multiple Myeloma

Treatments

Drug: zoledronic acid

Other: No treatment control

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01087008

AZABACHE: 2009-017440-13

Details and patient eligibility

About

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.

Full 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

Enrollment

103 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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