Multicenter open study to investigate the safety of Weekly therapy with NeoRecormon in patients with low-grade non-Hodgkin´s lymphoma, chronic lymphocytic leukemia or Multiple Myeloma.

Not Applicable

• Registration Number: PER-022-04
• Lead Sponsor: PRODUCTOS ROCHE Q.F.S.A.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2004-05-14
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Adult patients with a histologically confirmed diagnosis of low-grade non-Hodgkin´s lymphoma, chronic lymphocytic leukemia or multiple myeloma.
2. Hemoglobin <11 g / dL (<6.82 mmol / L) at the screening visit.
3. Serum erythropoietin level <100 mU / ml.
4. If antineoplastic therapy is to be administered, it must be scheduled for at least 4 months from the first dose of the study treatment.
5. Status performance WHO grade 0-2.
6. Life expectancy> of 6 months.
7. Written informed consent.

Exclusion Criteria

1. Transfusion of red blood cells during the 2 months prior to the first planned dose of the study medication.
2. Hypertension refractory to treatment.
3. Major acute or chronic bleeding requiring therapy within 3 months prior to the start of study treatment (patient with anemia caused by gastrointestinal bleeding).
4. Antineoplastic therapy in the week prior to the screening visit except use of corticosteroids and / or low dose of chlorambucil (Leukeran®).
5. Patients scheduled to receive bone marrow transplantation during the period of the treatment study.
6. Functional iron deficiency, for example transferrin saturation <20%, which can not be treated with intravenous iron supplement prior to the start of the study.
7. Thrombocytopenia grade 3/4: platelet count <50 x 10 ^ / L at the screening visit.
8. Deficiency of vitamin B12, example MCV of erythrocyte> 105 fL.
9. Folic acid deficiency, example MCV of erythrocyte> 105 μL.
10. Haemolysis: Haptoglobin <30 mg / dl (3.54 pmol / L) or other verifiable positive test for hemolysis.
11. Epilepsy.
12. Pregnancy or lactation period.

Study & Design

• Study Type: Interventional
• Study Design: Not specified