No registrations found.
ID
Source
Brief title
Health condition
Multiple Myeloma
Sponsors and support
P/a HOVON Data Center
Erasmus MC - Daniel den Hoed
Postbus 5201
3008 AE Rotterdam
Tel: 010 4391568
Fax: 010 4391028
e-mail: hdc@erasmusmc.nl
Koningin Wilhelmina Fonds (KWF)
Intervention
Outcome measures
Primary outcome
Time to the occurence of the first skeletal related event, from randomization.
Secondary outcome
1. The incidence of SREs per patient in the first 36 months from randomization;
2. Time to first SRE from registration;
3. Time to progression of bone metastasis;
4. Time to overall progression of disease;
5. Performance status (WHO);
6. Quality of life (QLQ-C30);
7. Bone resorption markers;
8. Objective bone lesion response from radiological studies.
Background summary
Study phase:
Phase III.
Study objectives:
Evaluation of the effect of zoledronate i.v. treatment duration in addition to chemotherapy.
Patient population:
Patients with multiple myeloma, previously untreated, Salmon & Durie stage II or III, age >= 18 years, included in HOVON 49 or HOVON 50 trial.
Study design:
Prospective, multicenter, randomized.
Duration of treatment:
Expected duration of zoledronate treatment is 12 months in arm A and 36 months in arm B.
Number of patients:
244 randomized patients (which corresponds with about 407 registered patients).
Study objective
The hypothesis to be tested is that the outcome in arm B is better than in arm A.
Study design
N/A
Intervention
All patients will receive Zoledronate 4 mg as a 15-minute i.v. infusion every 4 weeks for 12 months.
After 12 months these patients will be randomized between:
- Arm A: Off treatment
- Arm B: Zoledronate 4 mg as a 15-minute i.v. infusion every 4 weeks for 24 months.
P. Sonneveld
Erasmus University Medical Center,
Department of Hematology
Rotterdam 3000 CA
The Netherlands
+31 (0)10 7033589
p.sonneveld@erasmusmc.nl
P. Sonneveld
Erasmus University Medical Center,
Department of Hematology
Rotterdam 3000 CA
The Netherlands
+31 (0)10 7033589
p.sonneveld@erasmusmc.nl
Inclusion criteria
1. Patients with a confirmed diagnosis of multiple myeloma stage II or III according to the Salmon & Durie criteria;
2. Patients with at least one osteolytic bone lesion on conventional radiographs (plain film);
3. Inclusion in HOVON 49 or HOVON 50 trial;
4. Inclusion in HOVON 57 at the same time as inclusion in HOVON 49 or HOVON 50;
5. Date of inclusion in HOVON 57 trial before date start chemotherapy HOVON 49 or HOVON 50;
6. Age >=18 years;
7. WHO performance status 0-3;
8. Negative pregnancy test at inclusion if applicable;
9. Written informed consent.
Exclusion criteria
1. 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;
2. Corrected (adjusted for serum albumin) serum calcium < 2.00 mmol/l or > 2.80 mmol/l;
3. Serum creatinin > 265 micromol/l;
4. Total bilirubin > 30 micromol/l;
5. Patients unwilling or unable to comply with protocol;
6. Severe cardiac dysfunction (NYHA classification III-IV);
7. Patients with clinically significant hypersensitivity to zoledronic acid or other bisphosphonates;
8. Patients who are not willing or capable to use adequate contraception during the therapy (all men, all pre-menopausal women);
9. Lactating patients if applicable.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL196 |
| NTR-old | NTR233 |
| Other | : HO57 |
| ISRCTN | ISRCTN23172547 |