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
- 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
- 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
- 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