Phase IIa Study to Characterize the Effects of the Spiegelmer® NOX H94 on Anemia of Chronic Disease in Patients With Multiple Myeloma or Lymphoma
- Conditions
- Anemia of Chronic DiseaseD63.0Anaemia in neoplastic disease
- Registration Number
- DRKS00004366
- Lead Sponsor
- OXXON Pharma AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 48
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
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
11.Severe renal impairment: estimated glomerular filtration rate (eGFR) <30 mL/min (Cockcroft-Gault)
12.Known central nervous system malignancy or metastasis
13.Significant cardiac disease (e.g. uncontrolled hypertension: systolic blood pressure [BP] >150 mmHg or diastolic BP >100 mmHg; myocardial infarction or unstable angina pectoris) within 6 months prior to screening
14.Positive pregnancy test (serum ß-hCG at screening, urine pregnancy test prior to first treatment) or lactation
15.Previous participation in this study or treatment with an investigational agent <21 days prior to treatment start
16.Hemolysis or bleeding >500 mL (measured or estimated) within 6 weeks prior to treatment start
17.Treatment with erythropoiesis-stimulating agents (ESAs) or red blood cell (RBC) transfusions <21 days prior to treatment start
18.Cytotoxic anti-tumor treatment <21 days prior to treatment start or planned during the anticipated study period (within 3 months from treatment start or randomization). Maintenance therapy is permitted throughout the study (e.g. lenalidomide, interferon)
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method umber of treatment responders, defined by:<br>•Hb increase =1 g/dL OR reticulocyte index normalization (=1%) at any time point until 1 week after the end of treatment <br>AND absence of all of the following treatment failure criteria until 1 week after the end of treatment:<br>•Erythrocyte transfusion, ESA or IV iron, <br>•Hb drop by =1 g/dL <br>•Treatment interruption due to adverse events (AEs)<br>
- Secondary Outcome Measures
Name Time Method •Absolute values and change from baseline of<br>oHb, serum iron, transferrin, ferritin, TSAT, reticulocyte counts, RBC<br>oHepcidin <br>•Proportion of treatment responders at study visits V4, V6, V8, and V10 to V14, as defined for the primary efficacy endpoint <br>•Proportion of treatment failures at study visits V4, V6, V8, and V10, as defined for the primary efficacy endpoint<br>