DRKS00004366
Recruiting
Phase 2
Phase IIa Study to Characterize the Effects of the Spiegelmer® NOX H94 on Anemia of Chronic Disease in Patients With Multiple Myeloma or Lymphoma
OXXON Pharma AG0 sites48 target enrollmentSeptember 28, 2012
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Anemia of Chronic Disease
- Sponsor
- OXXON Pharma AG
- Enrollment
- 48
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Written informed consent
- •2\.Female or male aged \>18 years
- •3\.Clinically significant anemia of chronic disease (ACD) attributed to histologically or cytologically proven multiple myeloma, M. Hodgkin, or non\-Hodgkin lymphoma of any grade or stage:
- •Hemoglobin (Hb) 7\.0 g/dL to 10 g/dL,
- •Transferrin saturation (TSAT) \<20%,
- •Serum iron \<50 µg/dL
- •Ferritin \>30 ng/mL
- •4\.Previous treatment with systemic anti\-cancer therapy / regimen
- •5\.Eastern Cooperative Oncology Group (ECOG) performance status of \=2
- •6\.Estimated life expectancy \=12 weeks
Exclusion Criteria
- •1\.Inability to personally provide written informed consent or to understand and collaborate throughout the study
- •2\.History of pure red cell aplasia, thalassemia major or sickle cell disease
- •3\.History of anemia unrelated to cancer \<10 g/dL within 6 months prior to screening
- •4\.Uncorrected iron deficiency
- •5\.Regular need for blood transfusions at intervals \<6 weeks
- •6\.Acute or myeloid leukemia
- •7\.Suspected or known history of hemochromatosis
- •8\.Known infection with human immunodeficiency virus, hepatitis B, or hepatitis C
- •9\.Impaired liver function with bilirubin \=2\.0 mg/dL (26 µmol/L), AST or ALT \=2 times upper limit
- •10\.History of hepatic cirrhosis or organ transplantation
Outcomes
Primary Outcomes
Not specified
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