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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


Phase 4
18 Years
N/A
Open (Enrolling)
Both
Multiple Myeloma

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Trial Information

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


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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Time to next need treatment

Outcome Description:

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

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

García Sanz Ramon, Dr

Investigator Role:

Study Chair

Investigator Affiliation:

PETHEMA Foundation

Authority:

Spain: Ministry of Health

Study ID:

AZABACHE: 2009-017440-13

NCT ID:

NCT01087008

Start Date:

April 2010

Completion Date:

November 2013

Related Keywords:

  • Multiple Myeloma
  • Multiple Myeloma
  • Zoledronic acid
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

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