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Use of rHuEpo before autologous hematopoietic stem cell transplantation in patients affected by multiple myeloma, non Hodgkin disease and breast cancer to reduce transfusional requirement after myeloablative conditioning. A monocentric, phase III, open study. - ND

Use of rHuEpo before autologous hematopoietic stem cell transplantation in patients affected by multiple myeloma, non Hodgkin disease and breast cancer to reduce transfusional requirement after myeloablative conditioning. A monocentric, phase III, open study. - ND

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2007-005831-27-IT
Enrollment
Unknown
Registered
2008-05-21
Start date
2007-11-09
Completion date
Unknown
Last updated
2012-03-19

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

Conditions

autologous hematopoietic stem cells transplantation in patients affected by multiple myeloma, non Hodgkin disease and breast cancer MedDRA version: 9.1 Level: HLGT Classification code 10025320 Term: Lymphomas non-Hodgkin's B-cell MedDRA version: 9.1 Level: HLGT Classification code 10006232 Term: Breast disorders MedDRA version: 9.1 Level: HLGT Classification code 10035227 Term: Plasma cell neoplasms

Interventions

Trade Name: EPREX Pharmaceutical Form: Solution for injection INN or Proposed INN: Erythropoietin Concentration unit: U/ml unit(s)/millilitre Concentration type: equal Concentration number: 40000-

Sponsors

AZIENDA OSPEDALIERA OSPEDALE NIGUARDA CA' GRANDA (A.O. DI RILIEVO NAZIONALE)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: age > 18 years; IC; diagnosis of multiple myeloma, non Hodgkin disease and breast cancer; Hb =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: hereditary bone marrow disease; bleeding; lymphoblastic LNH; renal failure; cardiac disease; thrombosis; positive test HIV; pregnancy; incapability to understand the study

Design outcomes

Primary

MeasureTime frame
Main Objective: to evaluate the capability of rHuEpo to reduce the number of RBC units transfused during bone marrow aplasia;Secondary Objective: a) to evaluate the capability of rHuEpo to reduce the number of patients transfused during bone marrow aplasia b)to evaluate the capability of rHuEpo to increase the haemoglobin levels as compared to baseline haemoglobin levels c) to evaluate the safety of rHuEpo before autologous hematopoietic stem cell transplantation;Primary end point(s): to evaluate the capability of rHuEpo to reduce the number of RBC units transfused during bone marrow aplasia—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026