A multi-centre, randomised studyof Zoledronic Acid versus Observationin Patients with Asymptomatic Myeloma - ND

• Conditions: ewly diagnosed asymptomatic MM; MedDRA version: 9.1Level: LLTClassification code 10028228Term: Multiple myeloma

• Registration Number: EUCTR2006-003854-33-IT
• Lead Sponsor: AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06-27
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Understanding and voluntary signing of informed consent form (ICF)

Age 18 years at the time of signing ICF

Newly diagnosed asymptomatic MM

Asymptomatic MM, previously followed-up, with stable serum or urine M component (no

50% increase in serum or urine M component during the last 24 months)

Measurable M component in serum (

1.0 g/L for IgG, 0.5g/L for IgA or IgM) or urine (

0.2g/ 24h)

Bone marrow plasmacytosis > 10%

Absence of signs or symptoms of end organ damage attributable to neoplastic plasma cell

proliferation

No evidence of bone involvement at standard X-ray survey (osteolytic lesions, pathological

fractures) or MRI (structural damage or tumor masses; focal or diffuse signal alterations allow

inclusion)

Performance status ECOG 0-3

Bilirubin serum level < 2.5mg/dl

SGOT/SGPT < 2N

Ability to comply with trial requirements
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Symptomatic MM

Non secretory MM

Extramedullary plasmacytoma

Previous bisphosphonate therapy ( a three-month wash-out required in caso of treatment with

oral bisphosphonates for benign osteoporosis)

Hypersensitivity to bisphosphonates

Previous therapy for MM (either cytotoxic or Thalidomide/Thalidomide analogues/Bortezomib) Corrected serum calcium < 8mg/dl Hypercalcemia (1mg/dl > normal)

Calculated creatinine clearance < 30 ml/min or creatinine 1mg/dl > normal

Pregnancy or childbearing potential without any contraception method adopted

Prevoius history of malignancy other than MM, unless the subject has been free of the disease

for 5 years, except in situ carcinoma of the cervix or skin

Previous cancer metastatic to the bone

Bone-related disorder (e.g. Paget disease)

Amyloidosis

Any psychiatric illness impairing the ability to comply with trial requirements

Current active dental problems including infection of the teeth or jawbone (maxilla or

mandibular); dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw

(ONJ), of exposed bone in the mouth, or of slow healing after dental procedures (see appendix

for details).

Recent (within 6 weeks) or planned dental or jaw surgery (e.g. extraction, implants) (see

appendix for details)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified