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Clinical picture: MM (Multiple Myeloom)

Trial: HOVON 57 MM


News
1. Overview
Study details
2. Patient eligibility criteria
3. Registration (& randomization) of patients
4. Participating parties
5. Participating sites
6. Instruction videos
7. Download documentation / forms


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News


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1. Overview



Summary

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


Status

closed



Study details



Type of study

Prospective randomized Phase III study


Target number of patients

244


Date of activation

19-Apr-2004


Approved by

CKTO: CKTO 2003-08,3 November 2003
METC: METC Erasmus MC, 2 December 2003


2. Patient eligibility criteria



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.


3. Registration (& randomization) of patients



Registration

Central registration at the HOVON Data Center:
Erasmus MC Cancer Institute, Clinical Trial Center (Hs-423)
P.O. Box 2040
NL-3000 CA Rotterdam
Phone number.: +31.10.7041560 (working days 9.00-17.00)
Fax number.....: +31.10.7041028
TOP address...: http://www.hdc.hovon.nl/top


Registration criteria

The following information will be requested:



Protocol number
Institution name
Name of caller/responsible investigator
Patient's initials or code
Patient's hospital record number
Sex
Date of birth
Inclusion in HOVON 49 / HOVON 50 trial;
Date of inclusion in HOVON 49 / HOVON 50 protocol;
Patient study number in HOVON 49 / HOVON 50 trial;
Date start chemotherapy HOVON 49 / HOVON 50 trial;
Eligibility criteria


4. Participating parties



Principal investigator

P. Sonneveld (p.sonneveld@erasmusmc.nl)


Coordinating investigator(s)

P.W. Wijermans (p.wijermans@hagaziekenhuis.nl)


Statistician(s)

B. van der Holt (b.vanderholt@erasmusmc.nl)


Trial manager

J.G.M. Melssen (j.melssen@erasmusmc.nl)


Central data management

J.G.M. Melssen (j.melssen@erasmusmc.nl)


5. Participating sites



6. Instruction videos



7. Download documentation / forms




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