The hypothesis to be tested is that the outcome in arm B is better than in arm A.
ID
Bron
Verkorte titel
Aandoening
Multiple Myeloma
Ondersteuning
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)
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Time to the occurence of the first skeletal related event, from randomization.
Achtergrond van het onderzoek
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).
Doel van het onderzoek
The hypothesis to be tested is that the outcome in arm B is better than in arm A.
Onderzoeksopzet
N/A
Onderzoeksproduct en/of interventie
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.
Publiek
P. Sonneveld
Erasmus University Medical Center,
Department of Hematology
Rotterdam 3000 CA
The Netherlands
+31 (0)10 7033589
p.sonneveld@erasmusmc.nl
Wetenschappelijk
P. Sonneveld
Erasmus University Medical Center,
Department of Hematology
Rotterdam 3000 CA
The Netherlands
+31 (0)10 7033589
p.sonneveld@erasmusmc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL196 |
| NTR-old | NTR233 |
| Ander register | : HO57 |
| ISRCTN | ISRCTN23172547 |