Clinical Trial Result Information
Title of Study:
Open label, multicenter study to investigate the safety of once weekly NeoRecormon therapy in anemic patients with low-grade non-Hodgkin’s lymphoma, chronic lymphocytic leukemia or multiple myeloma.
Fast Facts:
| Protocol number: | ML18042 |
| Sponsor: | F. Hoffmann-La Roche Ltd |
| Company division: | Pharmaceutical |
| Product name: | NeoRecormon |
| Generic name: | epoetin beta |
| Phase of development: | IV |
| Therapeutic area, approved indication: | Anemia |
| Date of report: | 7/1/2006 |
Clinical study summary:
This was an open-label study in anemic patients with haematological malignancies, to investigate the safety of once weekly treatment, for 16 weeks, with NeoRecormon 30000 IU, administered via a pre-filled syringe. After 4 weeks’ treatment, the frequency of injections could be increased to twice weekly.
Study center(s) :
1 centre in Peru.
Objectives:
To assess the safety of once-weekly administration of NeoRecormon using the 30 000 IU pre-filled syringe in anemic patients with low-grade non-Hodgkin’s lymphoma, chronic lymphocytic leukemia or multiple myeloma.
Methodology:
After screening, eligible patients with haematological malignancies received weekly subcutaneous injections of NeoRecormon 30000 IU via pre-filled syringe. In the case of blood transfusion during week 4, or an inadequate hemoglobin response, the frequency of injections was increased to twice weekly, after 4 weeks. Study treatment was planned for 16 weeks.
Number of patients (planned/analyzed):
10 planned; 10 treated.
Diagnosis and main criteria for inclusion:
Adult patients with histologically confirmed diagnosis of low-grade non-Hodgkin’s lymphoma, chronic lymphocytic leukemia or multiple myeloma with hemoglobin <=11 g/dL (<=6.82 mmol/L) at screening visit, serum erythropoietin level at screening visit <=100mU/mL. WHO performance status grade 0-2, life expectancy >6 months.
Test product, dose and mode of administration or test procedure:
NeoRecormon (epoetin beta) 30000 IU pre-filled syringe. Starting dose: subcutaneous injection of 30000 IU NeoRecormon administered once weekly. If after 4 weeks of treatment: blood transfusion was necessary in the last week, or hemoglobin did not increase by at least 0.5 g/dL versus baseline, the frequency of injections was to be increased to 30000 IU twice weekly.
Duration of treatment:
16 weeks.
Reference therapy, dose and mode of administration or reference procedure:
N/A
Criteria for evaluation (efficacy, safety):
Adverse event rate and profile
Statistical methods:
The main conclusions of this study were based on the results of the per-protocol analysis. A descriptive statistical analysis of all adverse events occurring during this study was performed.
Summary (efficacy, safety, other results):
A total of 29 AEs were reported during the study. Hypocalcaemia events (17.2%), hypercalcaemia events, (13.8%), vomiting (6.9%) and leucopenia (6.9%) were the most frequently reported AEs in patients receiving NeoRecormon therapy. The majority of AEs recorded by patients were of moderate intensity. A total of 27/29 of the AEs were considered unrelated to NeoRecormon treatment. Two patients recorded 2 SAEs not related to NeoRecormon treatment. Seven patients were withdrawn prematurely as a result of early improvement (3), AEs (2) and refusal to continue treatment (2).
Conclusions:
In conclusion, in this study NeoRecormon was shown to be safe and well-tolerated in anemic patients with hematological malignancies.
Click here for the protocol registry listing of this trial.
