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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.

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.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REPEC
Registry ID
PER-022-04
Enrollment
10
Registered
2004-05-14
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Therapy with NeoRecormon® once a week in anemic patients with low-grade non-Hodgkins lymphoma, chronic lymphocytic leukemia or multiple myeloma.

Sponsors

PRODUCTOS ROCHE Q.F.S.A.,
Lead Sponsor

Eligibility

Inclusion criteria

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 of 6 months. 7. Written informed consent.

Exclusion criteria

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 105 fL. 9. Folic acid deficiency, example MCV of erythrocyte> 105 &#956;L. 10. Haemolysis: Haptoglobin <30 mg / dl (3.54 pmol / L) or other verifiable positive test for hemolysis. 11. Epilepsy. 12. Pregnancy or lactation period.

Design outcomes

Primary

MeasureTime frame
Outcome name:not contemplated Measure:not contemplated Timepoints:not contemplated

Secondary

MeasureTime frame
Outcome name:not contemplated Measure:not contemplated Timepoints:not contemplated

Countries

Peru

Outcome results

None listed

Source: REPEC (via WHO ICTRP)