- * Subjects (male or female) aged ≥18, suffering from a newly diagnosed or progressed/relapsed MM and scheduled to receive anti-myeloma treatment. Progression is defined according to "Uniform Response Criteria for Multiple Myeloma"
- * Subjects with progressed/relapsed MM should have had stable disease (during the last 6 months since prior treatment).
- * Life expectancy at least 6 months.
- * 8.5 g/dL ≤Hb ≤11 g/dL at time of randomisation.
- * Iron-restricted erythropoiesis as defined:
- * Stainable iron in bone marrow (BM) combined with transferrin saturation (TSAT) ≤20%, or
- * where the evaluation of stainable iron in BM is not possible or available:
- * ferritin \>30 ng/mL (women) or \>40 ng/mL (men), and
- * TSAT ≤20%
- * Females of child-bearing potential must have a negative urine pregnancy test at screening.
- * Before any study-specific procedure, the appropriate written informed consent must be obtained.
Influenza, Human
Flucelvax (TIVc or QIVc) Pregnancy Registry
NCT03438487 | PHASE 4 | OBSERVATIONAL
The study is a population based prospective cohort study designed to collect data on pregnancy outcomes and events of interest among women immunized with the TIVc or QIVc vaccine during pregnancy.
Trial Information
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Syneos Health
Wilmington,North Carolina,United States,28405
Study Eligibility Criteria
Additional Studies
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