Main info

Identificatie:

HOVON 57 MM

Sponsor:

HOVON

Included patients:

24

Active sites:

10

(of 10)

Title:

A randomized phase III study of i.v. zoledronate (administered for 12 versus 36 months) as an adjunct to standard therapies in the treatment of multiple myeloma.

Timeline

Flow

Details

Phase:

Prospective randomized Phase III study

Monitoring Type:

Objectives:

Eligibility

Inclusion Criteria:

• Patients with a confirmed diagnosis of multiple myeloma stage II or III according to the Salmon & Durie criteria;
• Patients with at least one osteolytic bone lesion on conventional radiographs (plain film);
• Inclusion in HOVON 49 or HOVON 50 trial;
• Inclusion in HOVON 57 at the same time as inclusion in HOVON 49 or HOVON 50;
• Date of inclusion in HOVON 57 trial before date start chemotherapy HOVON 49 or HOVON 50;
• Age >= 18 years;
• WHO performance status 0-3;
• Negative pregnancy test at inclusion if applicable;
• Written informed consent.

Patient Eligibility Criteria for randomization:

• Patients who received zoledronate infusions for 12 months from registration are eligible for randomization if:

Evaluation of radiography and blood parameters has been completed according to protocol.

Exclusion Criteria:

• Treatment with bisphosphonates at any time during the 12 months prior to registration. Exception: patients may have received up to 3 doses of a bisphosphonate for hypercalcaemia provided this has been administered >= 14 days prior to registration;
• Corrected (adjusted for serum albumin) serum calcium < 2.00 mmol/l or > 2.80 mmol/l;
• Serum creatinin > 265 umol/l;
• Total bilirubin > 30 umol/l;
• Patients unwilling or unable to comply with protocol;
• Severe cardiac dysfunction (NYHA classification III-IV) ;
• Patients with clinically significant hypersensitivity to zoledronic acid or other bisphosphonates;
• Patients who are not willing or capable to use adequate contraception during the therapy (all men, all pre-menopausal women);
• Lactating patients if applicable.

Exclusion criteria for randomisation:

• Development of TIH;
• Corrected (adjusted for serum albumin) serum calcium < 2.00 mmol/l or > 2.80 mmol/l;

Serum creatinin > 265 umol/l;
Total bilirubin > 30 umol/l;
Patients unwilling or unable to comply with protocol;
Severe cardiac dysfunction (NYHA classification III-IV) ;
Patients with clinically significant hypersensitivity to zoledronic acid or other bisphosphonates;
Excessive toxicity;
Progressive disease or relapse from CR.

Participating Sites

= Active hospitals

= Inactive hospitals