Clinical Trial Result Information

Protocol number
ML18042

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.

Sponsor
F. Hoffmann-La Roche Ltd

Company division
Pharmaceutical

Product name
NeoRecormon

Generic name
epoetin beta

Therapeutic area
Anemia

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.

Phase of development
IV

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.

Date of report
7/1/2006

Click here for the protocol registry listing of this trial.